Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006.
To compare the effects of pulmonary rehabilitation versus usual care on health-related quality of life and functional and maximal exercise capacity in persons with COPD.
We identified additional randomised controlled trials (RCTs) from the Cochrane Airways Group Specialised Register. Searches were current as of March 2014.
We selected RCTs of pulmonary rehabilitation in patients with COPD in which health-related quality of life (HRQoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. We defined 'pulmonary rehabilitation' as exercise training for at least four weeks with or without education and/or psychological support. We defined 'usual care' as conventional care in which the control group was not given education or any form of additional intervention. We considered participants in the following situations to be in receipt of usual care: only verbal advice was given without additional education; and medication was altered or optimised to what was considered best practice at the start of the trial for all participants.
We calculated mean differences (MDs) using a random-effects model. We requested missing data from the authors of the primary study. We used standard methods as recommended by The Cochrane Collaboration.
Along with the 31 RCTs included in the previous version (2006), we included 34 additional RCTs in this update, resulting in a total of 65 RCTs involving 3822 participants for inclusion in the meta-analysis.
We noted no significant demographic differences at baseline between members of the intervention group and those who received usual care. For the pulmonary rehabilitation group, the mean forced expiratory volume at one second (FEV1) was 39.2% predicted, and for the usual care group 36.4%; mean age was 62.4 years and 62.5 years, respectively. The gender mix in both groups was around two males for each female. A total of 41 of the pulmonary rehabilitation programmes were hospital based (inpatient or outpatient), 23 were community based (at community centres or in individual homes) and one study had both a hospital component and a community component. Most programmes were of 12 weeks' or eight weeks' duration with an overall range of four weeks to 52 weeks.
The nature of the intervention made it impossible for investigators to blind participants or those delivering the programme. In addition, it was unclear from most early studies whether allocation concealment was undertaken; along with the high attrition rates reported by several studies, this impacted the overall risk of bias.
We found statistically significant improvement for all included outcomes. In four important domains of quality of life (QoL) (Chronic Respiratory Questionnaire (CRQ) scores for dyspnoea, fatigue, emotional function and mastery), the effect was larger than the minimal clinically important difference (MCID) of 0.5 units (dyspnoea: MD 0.79, 95% confidence interval (CI) 0.56 to 1.03; N = 1283; studies = 19; moderate-quality evidence; fatigue: MD 0.68, 95% CI 0.45 to 0.92; N = 1291; studies = 19; low-quality evidence; emotional function: MD 0.56, 95% CI 0.34 to 0.78; N = 1291; studies = 19; mastery: MD 0.71, 95% CI 0.47 to 0.95; N = 1212; studies = 19; low-quality evidence). Statistically significant improvements were noted in all domains of the St. George's Respiratory Questionnaire (SGRQ), and improvement in total score was better than 4 units (MD -6.89, 95% CI -9.26 to -4.52; N = 1146; studies = 19; low-quality evidence). Sensitivity analysis using the trials at lower risk of bias yielded a similar estimate of the treatment effect (MD -5.15, 95% CI -7.95 to -2.36; N = 572; studies = 7).
Both functional exercise and maximal exercise showed statistically significant improvement. Researchers reported an increase in maximal exercise capacity (mean Wmax (W)) in participants allocated to pulmonary rehabilitation compared with usual care (MD 6.77, 95% CI 1.89 to 11.65; N = 779; studies = 16). The common effect size exceeded the MCID (4 watts) proposed by Puhan 2011(b). In relation to functional exercise capacity, the six-minute walk distance mean treatment effect was greater than the threshold of clinical significance (MD 43.93, 95% CI 32.64 to 55.21; participants = 1879; studies = 38).
The subgroup analysis, which compared hospital-based programmes versus community-based programmes, provided evidence of a significant difference in treatment effect between subgroups for all domains of the CRQ, with higher mean values, on average, in the hospital-based pulmonary rehabilitation group than in the community-based group. The SGRQ did not reveal this difference. Subgroup analysis performed to look at the complexity of the pulmonary rehabilitation programme provided no evidence of a significant difference in treatment effect between subgroups that received exercise only and those that received exercise combined with more complex interventions. However, both subgroup analyses could be confounded and should be interpreted with caution.
Pulmonary rehabilitation relieves dyspnoea and fatigue, improves emotional function and enhances the sense of control that individuals have over their condition. These improvements are moderately large and clinically significant. Rehabilitation serves as an important component of the management of COPD and is beneficial in improving health-related quality of life and exercise capacity. It is our opinion that additional RCTs comparing pulmonary rehabilitation and conventional care in COPD are not warranted. Future research studies should focus on identifying which components of pulmonary rehabilitation are essential, its ideal length and location, the degree of supervision and intensity of training required and how long treatment effects persist. This endeavour is important in the light of the new subgroup analysis, which showed a difference in treatment effect on the CRQ between hospital-based and community-based programmes but no difference between exercise only and more complex pulmonary rehabilitation programmes.
慢性阻塞性肺病的肺部復健
廣泛應用於慢性阻塞性肺病(COPD) 的肺部復健(也被稱為呼吸復健)，應展現可歸因於復健計畫的改善功能 (包括健康相關生活品質、功能性運動能力及最大運動能力)。本文獻回顧係更新2006年的文獻回顧研究報告。
比較肺部復健和一般照護對慢性阻塞性肺病患者的健康相關生活品質、功能性運動能力和最大運動能力的成效。
我們自Cochrane Airway Group Specialised Register找到更多隨機對照試驗，搜尋至2014年3月為止。
我們選擇有測量健康相關生活品質(HRQoL)及/或功能性運動能力(FEC)或最大(MEC)運動能力的肺部復健之慢性阻塞性肺病病人的隨機對照試驗。我們定義肺部復健為至少持續4周的運動訓練，不管有無衛教和心理支持。我們定義一般照護為常規照護，其中控制組沒有給予衛教或任何其他形式的介入。有下列情況我們認為參與者係接受為ㄧ般照護：只有給予口頭的建議而無其他的衛教，以及在試驗一開始時因考量什麼是最佳做法，針對所有參與者所做的藥物更改或調整。
我們採隨機效應模式計算平均差(MD)。我們向原研究作者徵詢遺漏的資料。我們依據The Cochrane Collaboration所建議的標準方法進行資料收集與分析。
包含先前版本(2006年)納入的31個隨機對照試驗，此次更新增加納入34個隨機對照試驗，總計納入65個隨機對照試驗，共包含3822位參與者在此次的統合分析中。
在試驗開始前，介入組和一般照護組兩組受試者間沒有顯著人口學上的差異。對於肺部復健組，平均第一秒用力呼氣量(forced expiratory volume at one second；FEV1) 預測有39.2 %，一般照護組為 36.4 %；平均年齡分別為62.4歲和62.5歲。兩組中的男女性別比約2：1。總共有41個肺部復健計畫是在醫院進行(住院病人或出院病人)，23個計畫是於社區進行(在社區中心或病人家中)，以及一個研究包含醫院和社區兩部分。大部分的計畫執行12周或8周，全部期間範圍由4周至52周。
介入的性質使得研究人員對受試者或計畫執行者要執行盲法是不可能的。此外，大部分早期的研究是否採取隱密分配也不清楚；且一些研究有的高的流失率，亦對整體的偏差風險有影響。
我們在所有納入的結果均看到有統計上的顯著改善。在生活品質的4個重要面向(慢性呼吸問卷分數(Chronic Respiratory Questionnaire；CRQ)的呼吸困難、疲勞、情緒功能和自覺對疾病的可控性)，效果比0.5單位的最小臨床重要差異值(minimal clinically important difference；MCID)大(呼吸困難： 平均差為 0.79, 95 % CI 0.56 至 1.03, 樣本數1283, 19個研究, 證據品質中等；疲勞：平均差 0.68, 95% CI 0.45 至 0.92, 樣本數1291, 19個研究, 證據品質低；情緒功能：平均差0.56, 95% CI 0.34至0.78, 樣本數1291, 19個研究；自覺對疾病的可控性：平均差 0.71, 95% CI 0.47至0.95, 樣本數1212, 19個研究, 證據品質低)。在聖喬治呼吸問卷的所有面向(St. George's Respiratory Questionnaire；SGRQ)均有統計上的顯著改善，總分則有4個單位的改善(平均差 -6.89, 95% CI -9.26 至 -4.52, 樣本數1146, 19個研究, 證據品質低)。以低偏差風險試驗進行敏感性分析亦得到相似的治療效果估算值 (平均差 -5.15, 95 % CI -7.95 至 -2.36, 樣本數 572, 7個研究)。
在功能性運動能力和最大運動能力兩者都顯示有統計上的顯著改善。相較於接受一般照護，分配到肺部復健的受試者，研究顯示有增加其最大運動能力(mean Wmax；W) (平均差 6.77, 95% CI 1.89 至 11.65, 樣本數779, 16個研究)。共通的成效量超過Puhan於2011年提出的MCID (4 瓦)。關於功能性運動能力，6分鐘行走距離的平均治療效果比臨床有顯著意義的閾值大(平均差 43.93, 95% CI 32.64 至 55.21, 參與人數 1879, 38個研究)。http://Puhan 2011(b)
比較於醫院內和社區兩種復健計畫的次群組分析，在慢性呼吸問卷的所有面向均顯示，次群組間有顯著的治療成效差異，一般來說，在醫院進行的肺部復健組比在社區進行的組別之平均值高。SGRQ問卷則沒有顯示這樣的差異。另外，依肺部復健計劃的複雜性進行次群組分析，只做運動和接受運動並結合更複雜的介入措施這兩個次群組間，其治療效果沒有顯著差異的證據。然而，此兩個次群組分析可能有干擾，其結果應該小心地解讀。
肺部復健可減緩呼吸困難和疲勞，改善情緒功能以及增進個案對自己疾病狀況的控制感，對病情有中等大且具臨床意義的改善。對於控制慢性阻塞性肺病來說，復健扮演很重要的一部分，有利於增進健康相關生活品質以及運動能力。我們認為在慢性阻塞性肺部疾病進行更多比較肺部復健和傳統照護的隨機對照試驗是沒有必要的，未來研究應該著重在確認肺部復健哪個部分是必要的、其理想的時間長度和地點、指導及所需訓練強度的程度，以及治療效果可以維持多久。本研究的重要在於由新次群組分析上，慢性呼吸問卷評估顯示，在醫院執行和在社區執行的計畫治療效果有差異，在只有做運動和較複雜的肺部復健計畫兩者間則沒有差異。
翻譯者：林芷筠
服務單位：嘉義長庚紀念醫院復健科
職稱：研究助理
本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail：cochranetaiwan@tmu.edu.tw
Pulmonary rehabilitation for chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) describes a chronic lung condition that prevents the air supply from getting to the lungs. Symptoms include breathlessness, coughing, tiredness and frequent chest infection. Worldwide, COPD is a major cause of ill health.
Pulmonary rehabilitation programmes include exercise as a key component; some programmes contain other interventions such as assessment, education, psychological support and dietary advice. Pulmonary rehabilitation is one of the key recommended approaches in the treatment of COPD. This review compared the impact of pulmonary rehabilitation versus usual care on the health-related quality of life of people with COPD. We included 65 studies involving 3822 participants. Participants were randomly assigned to receive pulmonary rehabilitation or usual care. The quality of the studies was generally good.
This review highlights that pulmonary rehabilitation improves the health-related quality of life of people with COPD. Results strongly support inclusion of pulmonary rehabilitation as part of the management and treatment of patients with COPD.
Future studies should concentrate on identifying the most important components of pulmonary rehabilitation, the ideal length of a programme, the intensity of training required and how long the benefits of the programme last.
慢性阻塞性肺病的肺部復健
慢性阻塞性肺部疾病(COPD)係指因空氣供應到肺部受到阻礙的一種慢性肺部症狀。症狀包含呼吸困難、咳嗽、疲累以及經常性胸腔感染。在全世界中，慢性阻塞性肺病是主要不健康的原因之一。
肺部復健計畫包含一個關鍵部分─運動；有些計畫尚有其他介入措施，如:評估、衛教、心理支持以及飲食建議。肺部復健是治療慢性阻塞性肺病重要的建議方法之一。本篇文獻回顧比較肺部復健和一般照護對慢性阻塞性肺病患者的健康相關生活品質的影響。我們納入65個研究，共包含3822位參與者，參與者隨機被分派至接受肺部復健或一般照護，研究的品質普遍是不錯的。
此文獻回顧指出肺部復健可改善慢性阻塞性肺部疾病患者的健康相關生活品質，本研究結果強烈支持將肺部復健納入為慢性阻塞性肺部疾病 控制及治療的一部份。
未來研究應該專注於釐清肺部復健最重要的部份、治療計畫理想的時間長度、所需訓練的運動強度、以及治療計畫的效益可維持多久。
譯註
翻譯者：林芷筠
服務單位：嘉義長庚紀念醫院復健科
職稱：研究助理
本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail：cochranetaiwan@tmu.edu.tw
நாள்பட்ட நுரையீரல் அடைப்பு நோய்க்கான நுரையீரல் மறுவாழ்வுச் சிகிச்சை
நாள்பட்ட நுரையீரல் அடைப்பு நோய் (க்ரானிக் அப்ஸ்டிரக்டிவ் பல்மொனரி டிசிஸ், சிஓபிடி) என்பது காற்று நுரையீரலுக்கு செல்வதை தடுக்கக் கூடிய ஒரு நாள்பட்ட நுரையீரல் நிலைமையாக வரையறுக்கப்படுகிறது. மூச்சுத்திணறல், இருமல், சோர்வு மற்றும் அடிக்கடி ஏற்படும் மார்பு தொற்று ஆகியவை இதன் அறிகுறிகளுள் அடங்கும். உலகளவில், ஆரோக்கியக் கேட்டிற்கு சிஓபிடி ஒரு முக்கிய காரணமாக உள்ளது.
நுரையீரல் மறுவாழ்வுத் திட்டங்கள் உடற்பயிற்சியை ஒரு முக்கியக் கூறாக உட்கொண்டிருக்கிறது; சில திட்டங்கள், மதிப்பீடு, கல்வி, உளவியல் ஆதரவு மற்றும் உணவுமுறை ஆலோசனை ஆகிய பிற தலையீடுகளைக் கொண்டிருக்கின்றன. சிஓபிடி சிகிச்சைக்காக பரிந்துரைக்கப்பட்ட அணுகுமுறைகளில் நுரையீரல் மறுவாழ்வுச் சிகிச்சை முக்கியமான ஒன்றாகும். இந்த திறனாய்வு, சிஓபிடி கொண்ட மக்களின் ஆரோக்கியம் தொடர்புடைய வாழ்க்கைத் தரத்தின் மேல் நுரையீரல் மறுவாழ்வுச் சிகிச்சையின் தாக்கத்தை வழக்கமான பராமரிப்பிற்கு எதிராக ஒப்பிட்டது. நாங்கள், 3822 பங்கேற்பாளர்கள் சம்பந்தப்பட்ட 65 ஆய்வுகளை சேர்த்தோம். சீரற்ற சமவாய்ப்பு முறையில், பங்கேற்பாளர்கள் நுரையீரல் மறுவாழ்வுச் சிகிச்சையை பெறுவதற்கோ அல்லது வழக்கமான பராமரிப்பை பெறுவதற்கோ ஒதுக்கப்பட்டனர். ஆய்வுகளின் தரம் பொதுவாக நன்றாக இருந்தது.
நுரையீரல் மறுவாழ்வுச் சிகிச்சை சிஓபிடி கொண்ட மக்களின் ஆரோக்கியம்-தொடர்புடைய வாழ்க்கைத் தரத்தை மேம்படுத்தியது என்று இந்த திறனாய்வு முனைப்பாகக் கூறுகிறது. சிஓபிடி கொண்ட நோயாளிகளில் நுரையீரல் மறுவாழ்வுச் சிகிச்சையை, மேலாண்மை மற்றும் சிஓபிடி கொண்ட நோயாளிகளுக்கான சிகிச்சையின் பகுதியாக சேர்ப்பதை முடிவுகள் வலுவாக ஆதரிக்கின்றன.
எதிர்கால ஆய்வுகள், திட்டத்தின் சிறந்த காலஅளவு, தேவையான பயிற்சி தீவிரம் மற்றும் எவ்வளவு காலம் திட்டத்தின் நன்மைகள் நீடிக்கும் போன்ற நுரையீரல் மறுவாழ்வுச் சிகிச்சையின் மிக முக்கிய கூறுகளை அடையாளம் காண்பதில் கவனம் செலுத்த வேண்டும்.
மொழிபெயர்ப்பு குறிப்புகள்
மொழி பெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், ஸ்ரீகேசவன் சபாபதி.
Plućna rehabilitacija u terapiji kronične opstruktivne plućne bolesti
Kronična opstruktivna plućna bolest (KOPB) kronično je plućno stanje u kojem je otežan protok zraka do plućnog parenhima. Simptomi uključuju otežano disanje, kašalj, umor i učestale infekcije u prsištu. KOPB jest jedna od najčešćih bolesti diljem svijeta.
Ključna komponenta programa plućne rehabilitacije je tjelovježba; neki programi uključuju i druge intervencije, poput procjene, edukacije, psihološke potpore i savjetovanja o prehrani. Plućna je rehabilitacija jedan od ključnih preporučenih pristupa u terapiji KOPB-a. Autori ovog Cochrane sustavnog pregleda usporedili su učinak plućne rehabilitacije s učinkom uobičajene njege na zdravstveni aspekt kvalitete života pacijenata koji boluju od KOPB-a. Uključeno je 65 studija s ukupno 3822 sudionika. Sudionici su metodom slučajnog odabira bili raspoređeni u skupine koje su podvrgnute plućnoj rehabilitaciji, odnosno uobičajenoj njezi. Kvaliteta studija je općenito bila dobra.
Ovaj sustavni pregled ističe da plućna rehabilitacija pozitivno utječe na zdravstveni aspekt kvalitete života u osoba s KOPB-om. Rezultati snažno podupiru uključivanje plućne rehabilitacije u terapiju pacijenata s KOPB-om.
Buduće bi se studije trebale fokusirati na utvrđivanje najbitnijih komponenti plućne rehabilitacije, idealnu duljinu trajanja programa, koliki je intenzitet treninga potreban, te koliko dugo traju pozitivni učinci same rehabilitacije.
Bilješke prijevoda
Cochrane Hrvatska
Prevela: Jelena Šimić
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr
Pulmonale Rehabilitation bei chronisch obstruktiver Lungenerkrankung
Die 'chronisch obstruktive Lungenerkrankung' (COPD) beschreibt eine chronische Lungenerkrankung, bei welcher die Luftzufuhr in die Lungen behindert wird. Zu den Symptomen gehören Kurzatmigkeit, Husten, Müdigkeit und wiederkehrende Atemwegsinfektionen. COPD spielt weltweit eine führende Rolle als Krankheitsursache.
Programme zur pulmonalen Rehabilitation beinhalten körperliches Training als einen wesentlichen Bestandteil; einige Programme beinhalten weitere Maßnahmen wie beispielsweise Befundaufnahme, Schulung, psychologische Unterstützung und Diätberatung. Die pulmonale Rehabilitation ist eine der vorrangig empfohlenen Ansätze in der Behandlung von COPD. Dieser Review vergleicht die Wirkung einer pulmonalen Rehabilitation gegenüber der Standardversorgung (übliche Versorgung) auf die gesundheitsbezogene Lebensqualität von Menschen mit COPD. Wir schlossen 65 Studien mit 3822 Teilnehmern ein. Die Teilnehmer wurden zufällig einer Gruppe mit pulmonaler Rehabilitation oder der Standardversorgung zugeteilt (randomisiert). Die Qualität der Studien war größtenteils gut.
Dieser Review unterstreicht, dass ein Programm zur pulmonalen Rehabilitation die gesundheitsbezogene Lebensqualität von Menschen mit COPD verbessert. Die Ergebnisse befürworten in hohem Maße den Einbezug eines Programms zur pulmonalen Rehabilitation als Teil des Managements und der Behandlung von Patienten mit COPD.
Zukünftige Studien sollten sich auf die Identifizierung der wichtigsten Bestandteile der pulmonalen Rehabilitation, die ideale Dauer eines Programms, die benötigte Intensität des Trainings und die Dauer des Nutzens der Programme konzentrieren.
Anmerkungen zur Übersetzung
M. Schmidt-Haghiri, freigegeben durch Cochrane Deutschland.
Легочная реабилитация при хронической обструктивной болезни легких
Хроническая обструктивная болезнь легких (ХОБЛ) это хроническое заболевание легких, при котором нарушается поступление воздуха в легкие. Симптомы ХОБЛ включают одышку, кашель, усталость/утомляемость и частые инфекции дыхательных путей. Во всем мире ХОБЛ является одной из основных причин плохого состояния здоровья.
Программы легочной реабилитации включают в себя упражнения в качестве ключевого компонента; некоторые программы включают другие вмешательства, такие как оценка, образование, психологическая поддержка и рекомендации по питанию. Легочная реабилитация является одним из ключевых рекомендуемых подходов в лечении ХОБЛ. В этом обзоре сравнили влияние легочной реабилитации, по сравнению с обычной помощью, на качество жизни, связанное со здоровьем, у людей с ХОБЛ. Мы включили 65 исследований с участием 3822 участников. Участники были рандомизированы [распределены в случайном порядке] в группы для получения легочной реабилитации или обычной помощи. Качество исследований, в целом, было хорошим.
В этом обзоре подчеркивается, что легочная реабилитация улучшает качество жизни, связанное со здоровьем, у людей с ХОБЛ. Результаты решительно поддерживают включение легочной реабилитации в лечение пациентов с ХОБЛ.
Будущие исследования следует сосредоточить на выявлении наиболее важных компонентов легочной реабилитации, идеальной длительности программы реабилитации, интенсивности необходимых тренировок, и на продолжительности полезного эффекта от проведения программы реабилитации.
Заметки по переводу
Перевод: Масалбекова Аида Азизбековна. Редактирование: Юдина Екатерина Викторовна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: lezign@gmail.com
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| Rehabilitation versus usual care for chronic obstructive pulmonary disease | |||||
| Patient or population: patients with chronic obstructive pulmonary disease Settings: hospital and community Intervention: rehabilitation versus usual care | |||||
| Outcomes | Illustrative comparative effects* (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Response on control | Treatment effect | ||||
| Usual care | Rehabilitation versus usual care | ||||
QoL - Change in CRQ (dyspnoea) (Higher is better and 0.5 unit is an important difference) | Median change = 0 units | Mean QoL - change in CRQ (Dyspnoea) in the intervention groups was 0.79 units higher (0.56 to 1.03 higher) | 1283 (19 studies) | ⊕⊕⊕⊝ Moderate 1,2,3 | Sensitivity analysis from studies at lower risk of bias was similar (MD 0.99, 95% CI 0.64 to 1.34; participants = 384; studies = 5; I2 = 34%) |
QoL - Change in SGRQ (total) (Lower is better and 4 units is an important difference) | Median change = 0.42 units | Mean QOL - change in SGRQ (total) in the intervention groups was 6.89 units lower (9.26 to 4.52 lower) | 1146 (19 studies) | ⊕⊕⊕⊝ Moderate 2,3,4 | Sensitivity analysis from studies at lower risk of bias was similar (MD -5.15, 95% CI -7.95 to -2.36; participants = 572; studies = 7; I2 = 51%) |
| Change in maximal exercise (Incremental Shuttle walk test (ISWT)) Distance metres Follow-up: median 12 weeks | Median change = 1 metre | Mean maximal exercise (incremental shuttle walk test) in the intervention groups was 39.77 metres higher (22.38 to 57.15 higher) | 694 (8 studies) | ⊕⊕⊕⊝ Moderate 2,3,5 | |
| Change in functional exercise capacity (6MWT)) Distance metres Follow-up: median 12 weeks | Median change = 3.4 metres | Mean functional exercise capacity (6MWT)) in the intervention groups was 43.93 metres higher (32.64 to 55.21 higher) | 1879 (38 studies) | ⊕⊝⊝⊝ Very low 2,3,6,7 | |
| Change in maximal exercise capacity (cycle ergometer) Workmax (watt) Follow-up: median 12 weeks | Median change = -0.05 watts | Mean maximal exercise capacity (cycle ergometer) in the intervention groups was 6.77 watts higher (1.89 to 11.65 higher) | 779 (16 studies) | ⊕⊕⊝⊝ Low 2,3,8,9 | |
| *The basis for the response on control is the median control group response across studies. CI: confidence interval; MD: mean difference. | |||||
| GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | |||||
Chronic obstructive pulmonary disease (COPD) is a multi-factorial progressive chronic lung disease that causes obstruction in airflow. This obstruction results in persistent and progressive breathlessness, productive coughing, fatigue and recurrent chest infection (GOLD 2014). COPD is also associated with extrapulmonary effects such as muscle wasting, osteopaenia (reduction in protein and mineral content of bone tissue), cardiovascular disease and depression and therefore is now best understood as a systemic disease (Agusti 2003; Agusti 2005). Worldwide, COPD is a major cause of morbidity. It is estimated that 210 million people are living with COPD (Franchi 2009), and it is projected that by the year 2030, COPD will be the third most frequent cause of death globally (WHO 2008). At this time, COPD is an incurable condition that is associated with significant economic costs due to progressive disease severity and frequent hospital admissions and readmissions (GOLD 2014; Guarascio 2013).
Risk factors for COPD are numerous and include genetics, recurrent respiratory infection, low socioeconomic status, exposure to air pollutants, poor nutrition and asthma (Eisner 2010; GOLD 2014). However smoking is recognised as a major cause of COPD, and the more a person smokes, the more likely he or she is to develop this condition (Forey 2011).
COPD is a heterogeneous condition with marked variation in progression between individuals (Casanova 2011; Nishimura 2013). The initial underlying pathology of COPD is confined to the lungs, and a clinical diagnosis is based on presenting symptoms and confirmation of airflow obstruction with a postbronchodilator spirometry forced expiratory volume in one second/forced vital capacity ratio (FEV1/FVC) < 0.70 (GOLD 2014). The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines are usually used to grade the severity of airflow limitations as mild (FEV1 ≥ 80% predicted: GOLD 1), moderate (50% ≤ FEV1 < 80% predicted: GOLD 2), severe (30% ≤ FEV1 50% predicted: GOLD 3) or very severe (FEV1 < 30% predicted: GOLD 4) (GOLD 2014).
The symptoms of COPD make engagement in physical activity unpleasant as the result of air trapping and increased hyperinflation in the lungs, which result in increased breathlessness due to subsequent inefficient breathing (O' Donnell 2007). Increased breathlessness provokes anxiety, which inevitably leads to further breathlessness, exacerbation of COPD symptoms and panic. This causes a vicious circle whereby any activities that involve physical exertion are avoided, causing muscle de-conditioning, which further reduces capacity to engage in physical activity (Bourbeau 2007). Physical inactivity is therefore a key predictor of mortality in people with COPD (Garcia-Aymerich 2006; Spruit 2013; Waschki 2011). Consequently, the joint American Thoracic Society and European Respiratory Society (ATS/ERS) (Spruit 2013) guidelines highlight the importance of exercise in the treatment and management of COPD.
Treatment interventions for COPD include smoking cessation, pharmacological and non-pharmacological therapies and, in specific circumstances, supplemental oxygen, ventilatory support, surgical treatment and palliative care (GOLD 2014). However, best evidence and all current international guidelines ratify the central role of pulmonary rehabilitation in the treatment of people with COPD (GOLD 2014; NICE 2010; Nici 2006; Ries 2007; Spruit 2013).
Pulmonary rehabilitation (PR), which was first defined by the American College of Chest Physicians Committee in 1974, is a proactive approach to minimising COPD symptoms, improving health-related quality of life (HRQoL) and increasing physical and emotional involvement in everyday life (GOLD 2014; Nici 2006; Ries 2007). The ATS in conjunction with the ERS has published numerous comprehensive statements on PR, with the most recent update in 2013. In the latest update, pulmonary rehabilitation was defined newly as a "…comprehensive intervention based on a thorough patient assessment followed by patient tailored therapies that include, but are not limited to, exercise training, education, and behaviour change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviours" (Spruit 2013). This new definition differs from the previous one (2006) in that it focuses on the interdisciplinary and therefore more holistic approach to PR rather than on the previous multi-disciplinary approach; highlights the importance of behaviour change; and places PR firmly within the concept of integrated care (Spruit 2013).
Depending on culture, healthcare systems and resources, the structure, personnel, content and settings of PR programmes may vary (Nici 2006; Spruit 2013). However, individually tailored exercise training is considered the cornerstone of PR (Nici 2006; Ries 2007; Spruit 2013). In particular, strength, low- and high-intensity training, exercise endurance and upper and lower extremity training are recommended (Nici 2006; Ries 2007, Spruit 2013). In addition to exercise, the typical comprehensive PR programme includes patient assessment, education, psychosocial support and nutritional counselling (ATS 1999; GOLD 2014; Spruit 2013). Pulmonary rehabilitation is typically delivered to groups of patients (rather than to individuals), but no evidence suggests the optimal size of the exercise group. However, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR 2011) recommends a staff-to-participant ratio of 1:4, and the British Thoracic Society (British Thoracic Society 2001) a ratio of 1:8. The setting for PR programmes varies; both community-based (Cambach 1997; Casey 2013; Wijkstra 1994a) and home-based programmes (Maltais 2008; Viera 2010) are available. However, traditionally, most PR programmes have been hospital based (Bourbeau 2010), with participants attending as in-patients or on an out-patient basis.
The optimal duration of programmes, number of sessions offered per week and type of staff required to deliver PR programmes are unclear. Beauchamp 2011 concludes, following a systematic review, that available evidence is insufficient to show the optimal duration of PR programmes for people with COPD. However, a programme duration of at least eight weeks is recommended to attain a substantial effect (Beauchamp 2011). Likewise the number of times per week that programmes are offered differs; typically hospital-based out-patient programmes are offered two or three days per week, and in-patient programmes are offered over five days (Spruit 2013). The optimal number of sessions required remains unclear. However, the 2006 ATS/ERS guidelines specify three sessions per week or a twice-weekly supervised and one unsupervised home session (Nici 2006). Finally, key requirements for staff delivering the programme are that they are clinically competent, having the required skills and knowledge and maintain patient safety (Spruit 2013).
Pulmonary rehabilitation seeks to reduce COPD symptoms, reestablish and improve functional ability, enhance participation in everyday life, promote autonomy and improve HRQoL (Spruit 2013). It does this by focusing on the systemic aspects of the disease that are common among patients with COPD (AACVPR 2011). The exercise component of PR increases inspiratory volume and reduces dynamic hyperinflation, both of which reduce dyspnoea when the person is performing tasks (Casaburi 2009). Exercise also increases muscle function, delaying fatigue and resulting in increased exercise tolerance. Meanwhile, the educational component of PR focuses on collaborative self-management and behaviour change (Spruit 2013). It encompasses providing information and knowledge regarding COPD; building skills such as goal setting, problem solving and decision making; and developing action plans that allow individuals to better recognise and manage the disease (Spruit 2013). The behaviour change element focuses on modifying nutritional intake and smoking patterns; adhering to medication and regular exercise; and utilising effective breathing techniques and energy-saving strategies (Spruit 2013).
Review authors undertook the original version of this Cochrane review in 2001 in response to worldwide endorsement of PR as integral to the management of COPD and lack of clear evidence as to the impact of these programmes on HRQoL and exercise tolerance (Lacasse 2001). The review included 23 randomised controlled trials (RCTs), and review authors concluded that PR (exercise training for a minimum of four weeks with or without education and/or psychological support) resulted in statistically significant improvement in HRQoL and modest improvement in exercise capacity (Lacasse 2001). This review was updated in 2006, included 31 RCTs and again reported statistically significant improvement in HRQoL. However, results for both functional and maximal exercise capacity were below the threshold of clinical significance. Lacasse 2006 concluded that further RCTs comparing PR versus usual care for patients with COPD were not needed. Despite this, a large number of RCTs published since 2006 have endorsed the need for this current update. Furthermore, recent RCTs tend to use disease-specific quality of life indices as primary outcome measures,, combined with more refined maximal and functional exercise capacity measurement tools (Curtis 2003; de Torres 2002; Gross 2004; Jones 2003). Consequently in the current review, we will take a more focused approach to assessment of primary and secondary outcomes. In recent years, wide variation has been noted in the follow-up assessment times utilised within studies, and this may have an impact on study outcomes. Therefore in the current review, we will include only assessments completed up to and within three months of completion of the intervention. Also, risk of bias requirements for Cochrane reviews have been altered since the last update; review authors of this current update will ensure that these new requirements are met. Finally, as a separate systematic review examining the effects of PR following exacerbations of COPD has been undertaken (Puhan 2011(a)), we will exclude from this review studies that commenced within four weeks of an acute exacerbation of COPD.
To compare the effects of pulmonary rehabilitation versus usual care on health-related quality of life and functional and maximal exercise capacity in persons with COPD.
All RCTs in which participants are randomly assigned at the individual or cluster level and in which researchers compare the effects of PR versus those of usual care.
We included RCTs in which more than 90% of participants had COPD defined as:
a clinical diagnosis of COPD; and
best recorded forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) (FEV1/FVC) ratio of individual participants < 0.7.
We included RCTs in which:
any or all participants were on continuous oxygen.
We excluded RCTs that focused on participants:
who were mechanically ventilated; or
who had an acute exacerbation within four weeks before commencement of the intervention.
Any in-patient, out-patient, community-based or home-based rehabilitation programme of at least four weeks' duration that included exercise therapy with or without any form of education and/or psychological support delivered to patients with exercise limitation attributable to COPD.
We included any exercise therapy that included physical activity considered to be aerobically demanding.
We excluded:
interventions in which the physical activity component was considered to be not aerobically demanding (e.g. respiratory muscle training, breathing exercises, Tai Chi, yoga) (the degree of aerobic demand was assessed for each individual intervention by examining the detailed description of the intervention in identified studies); and
programmes of less than 4 weeks' duration.
For the purpose of this review, usual care was defined as conventional care. We excluded trials in which the control group was given education or any form of additional intervention. Participants in the following situations were considered to be in receipt of usual care.
Only verbal advice was given. If the advice was accompanied by additional education provided in any way, for example, by video or by diary, then the study was excluded.
Medication was altered or optimised to what was considered best practice at the start of the trial for all participants.
We considered disease-specific HRQoL and/or maximal or functional exercise capacity (up to and including three months after the end of the intervention). We defined 'maximal exercise capacity' as the peak capacity measured by an incremental cycle ergometry test. 'Functional exercise capacity' was defined according to the results of timed walk tests (Holland 2014).
Chronic Respiratory Disease Questionnaire (CRQ).
St. George's Respiratory Questionnaire (SGRQ).
The classification of exercise testing is divided into functional and maximal exercise groups, which include the following (Holland 2014).
Functional exercise capacity assessments.
Six-minute walk test/distance (6MWT/6MWD).
Incremental shuttle walk test (ISWT).
Endurance shuttle walk test (ESWT).
Maximal exercise tests.
Incremental cycle ergometry.
We have detailed in Appendix 1 the search methods used in the previous version of this review. The previously published version included searches up to July 2004. The search period for this update is July 2004 to March 2014.
For the current update, we identified trials from the Cochrane Airways Group Specialised Register (CAGR), which is maintained by the Trials Search Co-ordinator for the Group. The Register contains trial reports identified through systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED) and PsycINFO, and by handsearching of respiratory journals and meeting abstracts (please see Appendix 2 for further details). We searched all records in the CAGR using the search strategy described in Appendix 3.
We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the World Health Organization (WHO) trials portal (www.who.int/ictrp/en/). We searched all databases from their inception to the present, with no restriction on the language of publication. We completed the latest searches in March 2014.
We reviewed the reference lists of relevant articles and retrieved any potential additional citations. We contacted the authors of studies included in the meta-analysis and experts in the field of pulmonary rehabilitation to uncover unpublished material. We also included the papers suggested by the study authors contacted.
The methods used in this review were designed in accordance with recommendations provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Two review authors (BMC, DC) independently tested the inclusion criteria and sought clarification on all areas of concern with the wider review team, which included the original author of the review (YL). When the review authors were confident of the clarity of the criteria and their skills, they assessed studies with respect to the identified criteria. The two review authors then independently assessed all citation titles and abstracts. Review authors electronically collated initial decisions with the use of Distiller SR and later with Early Reviewing Software (EROS); they coded each citation as:
included to proceed;
more information needed before inclusion decision;
important article but not to be included in the review; or
excluded (Appendix 4; Appendix 5).
Review authors held a meeting after every 100 reviewed citations during which they resolved disagreements by consensus. They used quadratic weighted Kappa statistics to measure agreement between coders (Kramer 1981). When consensus could not be reached, a third review author (DD) adjudicated. Review authors then retrieved full-text papers of all potentially eligible studies. Review authors maintained records on all studies that did not meet the inclusion criteria and provided the rationale for their exclusion.
The lead review author (BMC) extracted data from all original papers identified for inclusion in the meta-analysis using a developed data extraction form. The other members of the review group (DC, KM, DD, EM) independently extracted data from an equal share of the same studies. Extracted information included the following.
Background characteristics of the research reports.
Characteristics of participants in the study.
The number and distribution of participants who dropped-out or withdrew from the study.
A full description of the pulmonary rehabilitation programmes (setting, components and duration).
Health-related quality of life measurement instruments and associated results.
Exercise capacity measure outcomes and corresponding results.
The lead review author and co-review authors resolved discrepancies during the data extraction process through discussion; they consulted a third review author when unresolved issues remained. Review authors requested missing data from the authors of the primary studies. They asked these authors to provide additional information by filling in tables similar to the ones used by the review authors during the data extraction process. Two review authors (BMC, EM) entered all data into the Review Manager software (RevMan 2011) and checked them for accuracy.
If a study reported multiple group comparisons (e.g. exercise therapy with inspiratory muscle training compared with exercise therapy alone or with conventional community care), treatment groups considered relevant to PR were combined as if one intervention group,.and this group was compared with the group receiving conventional community care. Studies in which multiple group comparisons included interventions that were not considered relevant to PR such as acupuncture were not combined.
The lead review author (BMC) assessed the risk of bias for all included studies. A second review author (DC, EM or KM) independently assessed the risk of bias for each study. The review authors followed the criteria for assessing risk of bias provided by The Cochrane Collaboration in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and contained in RevMan (RevMan 2011). We assessed risk of bias according to the following domains (Appendix 6).
Random sequence generation.
Allocation concealment.
Blinding of participants and personnel.
Blinding of outcome assessment.
Incomplete outcome data.
Selective outcome reporting.
Other bias.
We considered several important potential sources of bias that have proved to be major determinants of the magnitude of the effect size in clinical trials: unconcealed randomisation, unblinded study personnel, incomplete outcome data and attrition of more than 20% of those randomly assigned. The first of these has been associated with an overestimation of treatment effect by up to 40% (Schulz 1995), and the second may result in differential encouragement during performance testing, with the potential for distortion of the results (up to 30.5 metres in a six-minute walk test) (Guyatt 1984). Schulz 1995 argued that loss to follow-up of 20% or greater should be a matter of concern as it relates to the possibility of bias.
Review authors resolved disagreements by consensus. If details pertaining to randomisation, masking, drop-out and withdrawal were not specified or were unclear in the original trial publication, we contacted the study authors to clarify the issue.
Different measures of HRQoL and exercise capacity have been reported in the primary studies. Both primary outcomes (HRQoL) and secondary outcomes (exercise capacity) are continuous outcomes. For these continuous variables, we recorded mean change from baseline or mean postintervention values and standard deviation (SD) for each group for outcomes measured using the same metrics. When 95% confidence intervals (CIs) and standard errors (SEs) were reported, we calculated SDs as guided by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). When SDs were missing from studies and it was not possible to obtain the results from study authors, we used a mean value for the SD of the other studies that reported that outcome. All outcomes were reported independently, so standardised mean differences (SMDs) for outcomes were not required. Mean differences (MDs) with 95% CIs were calculated for each study by using a random-effects model.
We did not plan to analyse dichotomous outcomes.
We included cluster-randomised trials in the analysis for the current review alongside individually randomised trials. We made an adjustment to the sample size in these studies for each intervention based on the method described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). This method utilised the intracluster correlation co-efficient (ICC) as calculated from trial results.
We included multi-armed trials in this review. To overcome potential issues due to multiple, correlated comparisons, we analysed multi-armed trials using methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). When feasible, we combined multiple comparison groups to create one relevant intervention group and one relevant comparison group.
For included studies, we noted the level of attrition; any study with greater than 20% attrition was considered at high risk of attrition bias. When standard deviations (SDs) of the change were missing from studies, and it was not possible to obtain the result from study authors, we used the mean value for the SD of other included studies that reported that outcome. We excluded from the analysis studies in which only medians and percentiles were available and study authors reported no other means of calculating mean change scores.
We assessed heterogeneity visually through inspection of forest plots, and statistical heterogeneity in each meta-analysis using Tau², I² and Chi² statistics. We regarded heterogeneity as substantial when Tau² was greater than zero and I² was greater than 30% or a low P value (< 0.10) was reported for the Chi² test for heterogeneity.
When 10 or more studies were included in the meta-analysis, we investigated reporting biases (such as publication bias) by using funnel plots. When asymmetry was suggested on visual assessment, we undertook exploratory analyses to investigate asymmetry using the test proposed by Egger 1997 (see Table 1).
| CRQ Fatigue | Bias indicators Begg-Mazumdar: Kendall's tau = 0.22807; P value 0.1863 Egger: bias = 1.61189 (95% CI = -0.194745 to 3.418525); P value 0.077 |
| CRQ Emotional | Bias indicators Begg-Mazumdar: Kendall's tau = 0.204678; P value 0.2378 Egger: bias = 0.997332 (95% CI = -0.618039 to 2.612702); P value 0.2101 |
| CRQ Mastery | Bias indicators Begg-Mazumdar: Kendall's tau = 0.146199; P value 0.4063 Egger: bias = 1.531134 (95% CI = -0.268167 to 3.330434); P value 0.0904 |
CRQ Dyspnoea (see Figure 4 for funnel plot) | Bias indicators Begg-Mazumdar: Kendall's tau = 0.274854; P value 0.1082 Egger: bias = 1.275427 (95% CI = -0.761574 to 3.312427); P value 0.204 |
SGRQ Total (see Figure 5 for funnel plot) | Bias indicators Begg-Mazumdar: Kendall's tau = -0.052632; P value 0.73 Egger: bias = -0.459813 (95% CI = -2.086751 to 1.167125); P value 0.5588 |
| SGRQ Symptoms | Bias indicators Begg-Mazumdar: Kendall's tau = 0.017544; P value 0.945 Egger: bias = 0.076734 (95% CI = -1.241745 to 1.395213); P value 0.9037 |
| SQRQ Activity | Bias indicators Begg-Mazumdar: Kendall's tau = -0.052632; P value 0.73 Egger: bias = -0.336937 (95% CI = -2.10096 to 1.427086); P value 0.692 |
| 6MWT | Bias indicators Begg-Mazumdar: Kendall's tau = 0.16074; P value 0.1601 Egger: bias = 1.24304 (95% CI = 0.183967 to 2.302131); P value 0.0227 |
| Incremental Shuttle Walk Test | Bias indicators Begg-Mazumdar: Kendall's tau = 0.0776906; P value 0.846 Egger: bias = -0.21 2523 (95% CI = -2.7776 to 2.351859); P value 0.846 |
| Cycle Ergometer | Bias indicators Begg-Mazumdar: Kendall's tau = -0.2666667; P value 0.139 |
Review authors undertook statistical analysis by using Review Manager software (RevMan 2011). Throughout the analysis, we used mean differences (MDs) as determined (to take into account pre-experiment group differences) from the differences between preintervention and postintervention changes in treatment and control groups. We combined MDs according to random-effects analyses (Shadish 1994) and presented the results as average treatment effects with 95% CIs and estimates of Tau² and I². In the case of cross-over trials, we considered only the first study period and excluded from the analysis data obtained during the second study period. We explored heterogeneity through a priori specified subgroup analyses. When possible, for each outcome, we discussed the summary effect estimate in the context of its minimal clinically important difference (MCID). The MCID is defined as the smallest difference in score corresponding to the smallest difference perceived by the average patient that would mandate, in the absence of troublesome side effects and excessive costs, a change in management of a patient's condition (Jaeschke 1989).
To explain anticipated heterogeneity among study results, we defined a set of three a priori hypotheses on which sensitivity analyses were to be based. We identified potential sources of heterogeneity in relation to the outcomes of exercise capacity and HRQoL. We then classified these hypotheses into subcategories as follows.
The contribution of each of the components of PR programmes to patient improvement in exercise capacity and HRQoL is not known. We hypothesised that the more comprehensive the rehabilitation programme, the larger would be the effect size in improving exercise capacity and HRQoL. We also hypothesised that a difference in intervention effect may be noted between hospital only-based and community/home-based interventions. Therefore, we performed a subgroup analysis of:
pulmonary rehabilitation and exercise only interventions versus PR plus a more comprehensive intervention within which education was included; and
hospital only-based versus community/home-based programmes.
We hypothesised that the results of trials would be influenced by their methodological quality. For the purpose of this subgroup analysis, we defined high-quality trials as those at low risk of bias for:
allocation concealment; or
incomplete outcome data (i.e. loss to follow-up ≥ 20%).
We assessed for subgroup differences by using interaction tests available within RevMan (RevMan 2011). We reported the results of subgroup analyses by quoting the statistic and the P value, and the interaction test by providing the I² value.
We performed sensitivity analyses on the basis of trial quality by repeating our analysis among only those trials judged to be of 'high quality.' For the purposes of this review, 'high-quality' trials are defined as trials with low risk of bias due to allocation concealment or low risk of bias due to incomplete outcome data. We limited sensitivity analyses to primary outcomes (see Types of outcome measures).
See Characteristics of included studies and Characteristics of excluded studies as well as baseline characteristics (Table 2) and study design (Table 3).
| ||||||||||
| Study | Rehab sample size | Male | Female | Mean age (SD) | FEV1 (SD) | Control sample size | Male | Female | Mean age (SD) | FEV1 (SD) |
| Barakat 2008 | 35 | na | na | 63.7 | 41.9 | 36 | na | na | 65.9 | 43.3 |
| Baumann 2012 | 37 | na | na | 65 | 45 | 44 | na | na | 63 | 47 |
| Behnke 2000a | 23 | 12 | 3 | 64.0 (1) | 34.1 (7.4) | 23 | 11 | 4 | 68.0 (2.2) | 37.5 (6.6) |
| Bendstrup 1997 | 27 | 7 | 9 | 64 (3) | 1.02 L/min (0.06) | 20 | 7 | 9 | 65 (2) | 1.04 L/min (0.07) |
| Booker 1984 | 32 | na | na | 66 (8) | 0.85 L (0.29) | 37 | na | na | 65 (7) | 0.97 L (0.37) |
| Borghi-Silva 2009 | 20 | 13 | 7 | 67 (10) | 33 (9) | 14 | 12 | 8 | 67(10) | 35 (11) |
| Boxall 2005 | 23 | 11 | 12 | 77.6 (7.6) | 40.5 (15.9) | 23 | 15 | 8 | 75.8 (8.1) | 37.7 (15.0) |
| Busch 1988 | 7 | 5 | 2 | 65 (16) | 26% (9) | 7 | 6 | 1 | 66 (16) | 27% (11) |
| Cambach 1997 | 15 | 7 | 8 | 62 (5) | 59% (16) | 8 | 6 | 2 | 62 (9) | 60% (23) |
| Casaburi 2004 | 12 | 12 | 0 | 69 (10) | 36% (9) | 12 | 12 | 0 | 68 (9) | 39% (12) |
| Casey 2013 | 178 | 117 | 61 | 68.8 (10.2) | 57.6 (14.3) | 172 | 106 | 66 | 68.4 (10.3) | 59.7 (13.8) |
| Cebollero 2012 | 28 | 28 | 0 | 68 (7) | 47.8 (5) | 8 | 8 | 0 | 69(5) | 38.7 (5) |
| Chan 2011 | 69 | 61 | 8 | 73.6 (7.5) | 91 (0.39) | 67 | 58 | 9 | 73.6 (7.4) | 89 (0.39) |
| Chlumsky 2001 | 13 | 12 | 1 | 63 (11) | 43% (21) | 6 | 5 | 1 | 65 (13) | 51% (17) |
| Clark 1996 | 32 | na | na | 58 (8) | 1.72 L (0.83) | 16 | na | na | 55 (8) | 1.44 L (0.59) |
| Cochrane 2006 | 74 | 32 | 42 | na | na | 50 | 18 | 32 | na | na |
| Cockcroft 1981 | 18 | 18 | 0 | 61 (5) | 1.53 L (0.70) | 16 | 16 | 0 | 60 (5) | 1.32 L (0.44) |
| De Souto Araujo 2012 | 21 | 12 | 9 | 59 | 39.2 (11.4) /43.9 (10.3) | 11 | 8 | 3 | 71.1 | 45.1 (12.6) |
| Deering 2011 | 25 | 11 | 14 | 67.7 (5.3) | 77.0 (19) | 19 | 8 | 8 | 68.6 (5.5) | 45.8 (18.3) |
| Elci 2008 | 39 | 33 | 6 | 59.67 (8.6) | 47.7 | 39 | 33 | 6 | 58.08 (11.45) | 46.28 |
| Emery 1998 | 25 | 15 | 14 | 65 (6) | 1.29 L (0.63) | 25 | 12 | 13 | 67 (7) | 1.02 L (0.37) |
| Engström 1999 | 26 | 14 | 12 | 66 (5) | 31% (11) | 24 | 12 | 12 | 67 (5) | 34% (10) |
| Faager 2004 | 10 | 3 | 7 | 72 (9) | 26 (7) | 10 | 3 | 7 | 70 (8) | 28 (6) |
| Faulkner 2010 | 10 | na | na | na | na | 10 | na | na | na | na |
| Fernandez 2009 | 30 | 29 | 1 | 66 (8) | 33 (10) | 20 | 20 | 0 | 70 (5) | 38 (12) |
| Finnerty 2001 | 36 | 25 | 11 | 70 (8) | 41% (19) | 29 | 19 | 10 | 68 (10) | 41% (16) |
| Gohl 2006 | 17 | 6 | 4 | 62.5 (7) | 53.4 (10.7) | 17 | 7 | 2 | 53.7 (5.8) | 63.2 (8.5) |
| Goldstein 1994 | 38 | 21 | 17 | 66 (7) | 35% (15) | 40 | 17 | 23 | 65 (8) | 35% (12) |
| Gosselink 2000 | 37 | 31 | 6 | 60 (9) | 41% (16) | 33 | 30 | 3 | 63 (7) | 43% (12) |
| Gottlieb 2011 | 35 | 7 | 15 | 74.1 (66–82) | 64.27 (7.9) | 26 | 7 | 13 | 73.2 (67–88) | 67.05 (8.8) |
| Griffiths 2000 | 93 | 57 | 37 | 68 (8) | 40% (16) | 91 | 54 | 37 | 68 (8) | 39% (16) |
| Gurgun 2013 | 30 | 28 | 28 | 64.0 (10.8) | 41.9 (10.8) | 16 | 15 | 1 | 67.8 (6.6) | 39.3 (9.3) |
| Güell 1995 | 30 | 30 | 30 | 64 (7) | 31% (12) | 30 | 30 | 0 | 66 (6) | 39% (14) |
| Güell 1998 | 18 | 16 | 2 | 68 (8) | 32% (11) | 17 | 17 | 0 | 66 (8) | 38% (15) |
| Hernandez 2000 | 20 | 20 | 0 | 64 (8) | 71.1 (18.9) | 17 | 17 | 0 | 63 (7) | 74.7 (14.7) |
| Hoff 2007 | 6 | 4 | 2 | 62.8 (1.4) | 49.9 (4.6) | 6 | 4 | 2 | 60.6 (3.0) | 45.2 (6.0) |
| Jones 1985 | 8 | 6 | 2 | 64 (6) | 0.78 L (0.27) | 6 | 1 | 5 | 63 (8) | 0.68 L (0.12) |
| Karapolat 2007 | 26 | 21 | 5 | 64.81 (9.4) | 55.50% | 19 | 18 | 1 | 67.21 (6.72) | 58% |
| Lake 1990 | 7 | 6 | 1 | 66.3 (6.8) | 0.83 L (0.25) | 7 | 4 | 3 | 65.7 (3.5) | 0.97 L (0.29) |
| Lindsay 2005 | 25 | 20 | 5 | 69.5 (9.3) | 0.9 L (0.3) | 25 | 18 | 7 | 69.8 (10.3) | 0.8 L (0.4) |
| Liu 2012 | 36 | 26 | 10 | 61.34 (8.3) | 61.27 (5.86) | 36 | 29 | 7 | 62.2 (6.34) | 61.43 (6.17) |
| McGavin 1977 | 12 | 12 | 0 | 61 (6) | 0.97 L (0.33) | 12 | 12 | 0 | 57 (8) | 1.15 L (0.72) |
| McNamara 2013 | 38 | 18 | 15 | 72 (10) | 60 (10) | 15 | 8 | 7 | 70 (9) | 55 (20) |
| Mehri 2007 | 20 | 11 | 9 | 52.1 (10.7) | na | 18 | 7 | 11 | 52.17 (11.6) | na |
| Mendes De Oliveira 2010 | 56 | 46 | 10 | 66.4/71.3 | 47.5/ 51.5 | 29 | 19 | 10 | 70.8 | 41.4 |
| Nalbant 2011 | 14 | 11 | 3 | 73.5 | 58.5 (48-65) | 15 | 13 | 2 | 68 | 57 (44-66) |
| O'Shea 2007 | 27 | na | na | 66.9 (7) | 49 | 27 | na | na | 68.4 (9.9) | 52 |
| Ozdemir 2010 | 25 | 25 | 0 | 60.9 (8.8) | 54.5 (15.6) | 25 | 25 | 0 | 64.1 (8.9) | 54.1 (20.2) |
| Paz-Diaz 2007 | 10 | 6 | 4 | 67 (5) | 34 (11) | 14 | 12 | 2 | 62 (7) | 30 (9) |
| Petty 2006 | 149 | 80 | 69 | 68.8 (9.2) | na | 73 | 40 | 33 | 66.8 (9.9) | na |
| Reardon 1994 | 10 | 5 | 5 | 66 (8) | 35% (10) | 10 | 5 | 5 | 66 (7) | 33% (15) |
| Ringbaek 2000 | 24 | 1 | 23 | 62 (7) | 50% (17) | 21 | 6 | 15 | 65 (8) | 44% (14) |
| Gomez 2006 | 64 | 39 | 9 | 64.1/64.9 | 74 (66.5-81.5) | 33 | 19 | 4 | 63.4 | 60.1 (55.6-64.4) |
| Simpson 1992 | 14 | 5 | 9 | 73 (5) | 40% (19) | 14 | 10 | 4 | 70 (6) | 39% (21) |
| Singh 2003 | 20 | na | na | na | 28 (7.5) | 20 | na | na | na | 26 (7.1) |
| Sridhar 2008 | 61 | 30 | 31 | 69.9 (9.6) | 42.9 (15.5) | 61 | 30 | 31 | 69.68 (10.4) | 48.9 (18.69) |
| Strijbos 1996 | 15 | 14 | 1 | 61 (6) | 40% (20) | 15 | 12 | 3 | 63 (5) | 43% (9) |
| Theander 2009 | 15 | 3 | 9 | 66 | 35.1 (7.6) | 15 | 10 | 4 | 64 | 32.3 (9.5) |
| Vallet 1994 | 10 | 7 | 3 | 60 (9) | 57.2 | 10 | 8 | 2 | 58 (6) | 55.7 |
| Van Wetering 2010 | 102 | 72 | 30 | 65.9 (8.8) | 58 (17) | 97 | 69 | 28 | 67.2 (8.9) | 60 (15) |
| Vijayan 2010 | 16 | na | na | na | na | 15 | na | na | na | na |
| Weiner 1992 | 12 | 6 | 6 | 67 (9) | 32.8 (3) | 12 | 5 | 7 | 61 (9) | 39.2 (2.8) |
| Wen 2008 | 32 | 31 | 1 | 67 (7)/68 (7) | 46 (10)/50 (14) | 9 | 9 | 0 | 66(10) | 52 (14) |
| Wijkstra 1994 | 28 | 23 | 5 | 64 (5) | 44% (11) | 15 | 14 | 1 | 62 (5) | 45% (9) |
| Xie 2003 | 25 | 22 | 3 | 54 (6) | 42% (16) | 25 | 21 | 4 | 54 (6) | 40% (17) |
| Study | Follow-up | Duration (weeks) | Setting | Programme type |
| Barakat 2008 | 14 weeks | 14 | Outpatient | Exercise + other |
| Baumann 2012 | 6 months | 8 | Community | Exercise + other |
| Behnke 2000a | 3, 6 months | 24 | Inpatient | Exercise + other |
| Bendstrup 1997 | 12, 24 weeks | 12 | Outpatient | Exercise |
| Booker 1984 | 3, 6, 12 months | 9 | Home | Exercise + other |
| Borghi-Silva 2009 | 6 weeks | 6 | Outpatient | Exercise |
| Boxall 2005 | 12 weeks | 12 | Home | Exercise + other |
| Busch 1988 | 18 weeks | 18 | Home | Exercise |
| Cambach 1997 | 3 months | 12 | Community | Exercise + other |
| Casaburi 2004 | 10 weeks | 10 | Outpatient | Exercise + other |
| Casey 2013 | 12 weeks | 8 | Community | Exercise + other |
| Cebollero 2012 | 12 weeks | 12 | Outpatient | Exercise |
| Chan 2011 | 3 months | 12 | Community | Exercise |
| Chlumsky 2001 | 8 weeks | 8 | Outpatient | Exercise |
| Clark 1996 | 12 weeks | 12 | Home | Exercise |
| Cochrane 2006 | 6 weeks, 6 months, 12 months | 6 | Outpatient | Exercise + other |
| Cockcroft 1981 | 2, 6 months | 6 | Outpatient | Exercise |
| De Souto Araujo 2012 | 8 weeks | 8 | Community | Exercise |
| Deering 2011 | 8 weeks | 7 | Outpatient | Exercise + other |
| Elci 2008 | 1, 3 months | 12 | Community /Home | Exercise + other |
| Emery 1998 | 10 weeks | 10 | Outpatient | Exercise + other |
| Engström 1999 | 12 months | 52 | Outpatient /Home | Exercise + other |
| Faager 2004 | 8 weeks, 6 months | 8 | Inpatient /Home | Exercise + other |
| Faulkner 2010 | week 9 | 8 | Community | Exercise + other |
| Fernandez 2009 | 1 year | 52 | Home | Exercise + other |
| Finnerty 2001 | 12, 24 weeks | 6 | Outpatient | Exercise + other |
| Gohl 2006 | 12 months | 52 | Community | Exercise |
| Goldstein 1994 | 24 weeks | 8 | Inpatient | Exercise + other |
| Gosselink 2000 | 6, 18 months | 24 | Outpatient | Exercise |
| Gottlieb 2011 | 6 months | 7 | Community | Exercise + other |
| Griffiths 2000 | 1 year | 6 | Outpatients /Home | Exercise + other |
| Gomez 2006 | 3, 6 months | 12 | Community | Exercise + other |
| Güell 1995 | 3, 6, 9, 12, 18, 24 months | 12 | Outpatient /Home | Exercise |
| Güell 1998 | 8 weeks | 8 | Outpatient | Exercise |
| Gurgun 2013 | 8 weeks, 6 months | 8 | Outpatient | Exercise + other |
| Hernandez 2000 | 12 weeks | 12 | Home | Exercise |
| Hoff 2007 | 8 weeks | 8 | Outpatient | Exercise |
| Jones 1985 | 10 weeks | 10 | Home | Exercise |
| Karapolat 2007 | 8, 12 weeks | 8 | Outpatient | Exercise + other |
| Lake 1990 | 8 weeks | 8 | Outpatient | Exercise |
| Lindsay 2005 | 6 weeks, 3 months | 6 | Community | Exercise + other |
| Liu 2012 | 6 months | 24 | Inpatient /Home | Exercise |
| McGavin 1977 | 14 weeks | ?12 | Home | Exercise |
| McNamara 2013 | 8 weeks | 8 | Outpatient | Exercise |
| Mehri 2007 | 4 weeks | 4 | Outpatient | Exercise |
| Mendes De Oliveira 2010 | 12 weeks | 12 | Outpatient /Home | Exercise + other |
| Nalbant 2011 | 3, 6 months | 24 | Nursing home | Exercise + other |
| O'Shea 2007 | 3, 6 months | 12 | Outpatient /Home | Exercise |
| Ozdemir 2010 | 1 month | 4 | Outpatient | Exercise |
| Paz-Diaz 2007 | 8 weeks | 8 | Outpatient | Exercise |
| Petty 2006 | 8 weeks | 8 | Home | Exercise + other |
| Reardon 1994 | 6 weeks | 6 | Outpatient | Exercise + other |
| Ringbaek 2000 | 8 weeks | 8 | Outpatient | Exercise + other |
| Simpson 1992 | 8 weeks | 8 | Outpatient | Exercise |
| Singh 2003 | 4 weeks | 4 | Home | Exercise |
| Sridhar 2008 | 6 months | 6 | Outpatients /Home | Exercise + other |
| Strijbos 1996 | 3, 6, 12, 18 months | 12 | Outpatient | Exercise + other |
| Theander 2009 | 12 weeks | 12 | Outpatient /Home | Exercise + other |
| Vallet 1994 | 8 weeks | 8 | Inpatient | Exercise |
| Van Wetering 2010 | 4 months | 12 | Community | Exercise + other |
| Vijayan 2010 | Unclear | 6 | Unclear | Exercise |
| Weiner 1992 | 6 months | 24 | Outpatient | Exercise |
| Wen 2008 | 12 weeks | 12 | Outpatient | Exercise |
| Wijkstra 1994 | 12 weeks | 12 | Outpatient /Home | Exercise + other |
| Xie 2003 | 12 weeks | 12 | Home | Exercise |
Our search yielded 1284 citations with potential for inclusion (see Figure 1). We excluded 1132 citations during the initial screening of titles and abstracts and assessed 98 studies (152 citations) on the basis of a full-text review. Of these, 51 studies (68 citations) failed to meet the inclusion criteria. A further five studies (eight citations) provided insufficient detail to allow a decision and are still awaiting classification (see Characteristics of studies awaiting classification). Of these, we conducted a teleconference with the author of two studies (Meshcheryakova 2010; Meshcheryakova 2012) and are awaiting additional unpublished information. We were not able to establish contact with the authors of the other three studies (Aksu 2006; D'Amico 2010; Ren 2011). Three studies were ongoing at the time of this review, and results were not yet published; the study authors wished to withhold results until after publication (Chang 2008; Gurgun 2011; Sathyapala 2008) (see Characteristics of ongoing studies). In addition, eight citations were related to five studies that were already included in the previous version of this review. Thus, 34 studies (65 citations) were included for the first time in this review, in addition to the 31 studies (65 citations) already included in the previous version of the review. We have provided details of the literature search for the previous version of the review in Appendix 1.
Study flow diagram.
We included the 31 RCTs from the 2006 version of the Cochrane review (Lacasse 2006). A total of 65 studies (represented by 130 citations) contributed to this meta-analysis, including 34 new studies (Barakat 2008; Baumann 2012; Borghi-Silva 2009; Casey 2013; Cebollero 2012; Chan 2011; Cochrane 2006; De Souto Araujo 2012; Deering 2011; Elci 2008; Faager 2004; Faulkner 2010; Fernandez 2009; Gohl 2006; Gomez 2006; Gottlieb 2011; Gurgun 2013; Hoff 2007; Karapolat 2007; Lindsay 2005; Liu 2012; McNamara 2013; Mehri 2007; Mendes De Oliveira 2010; Nalbant 2011; O'Shea 2007; Ozdemir 2010; Paz-Diaz 2007; Petty 2006; Sridhar 2008; Theander 2009; Van Wetering 2010; Vijayan 2010; Wen 2008), in addition to the 31 studies included in the original review (Behnke 2000a; Bendstrup 1997; Booker 1984; Boxall 2005; Busch 1988; Cambach 1997; Casaburi 2004; Chlumsky 2001; Clark 1996; Cockcroft 1981; Emery 1998; Engström 1999; Finnerty 2001; Goldstein 1994; Gosselink 2000; Griffiths 2000; Güell 1995; Güell 1998; Hernandez 2000; Jones 1985; Lake 1990; McGavin 1977; Reardon 1994; Ringbaek 2000; Simpson 1992; Singh 2003; Strijbos 1996; Vallet 1994; Weiner 1992; Wijkstra 1994; Xie 2003). We provided descriptions of these individual studies in the Characteristics of included studies table.
These studies involved 3822 participants, 2090 of whom were randomly allocated to some form of exercise rehabilitation for a minimum duration of four weeks, and 1732 individuals who were randomly assigned to usual care. For a detailed account of the criteria required for inclusion, see Criteria for considering studies for this review. The sample size in the included studies ranged from 12 participants (Hoff 2007) to 350 participants (Casey 2013) with a median of 45 participants (interquartile range (IQR) 29.5 to 67). We noted a large gender imbalance across all studies, with 69% of participants being male and with 10 studies including no female participants.
Only six studies reported patient-based programmes, three of which were combined with a home-based follow-up component. Thirty-seven studies were hospital out-patient based; eight of these included a home-based element. In all, 21 programmes were community based, 11 of which were entirely home based, and one programme combined community- and home-based components. The venue for the programme run by Vijayan 2010 was unclear from the reports. The duration of the programmes ranged from four weeks (three studies) to one year (three studies). Eight- and 12-week programmes (18 studies of each) were most common. Timelines for assessment of participants followed a pattern identical to that of programme duration.
All but two trials that met the inclusion criteria used a standard parallel-group design. Casey 2013 utilised cluster samples from general practices, whereas Cambach 1997 conducted a cross-over trial. Most studies (48 trials) randomly assigned participants to two groups (i.e. rehabilitation and usual care), and three trials randomly assigned participants to three intervention groups, in addition to the usual care group (Casaburi 2004; Cochrane 2006; Lake 1990). The remaining 14 trials utilised two intervention groups and a usual care group (Cebollero 2012; De Souto Araujo 2012; Deering 2011; Emery 1998; Gomez 2006; Gurgun 2013; Jones 1985; Liu 2012; McNamara 2013; Mendes De Oliveira 2010; Petty 2006; Strijbos 1996; Weiner 1992; Wen 2008)
We excluded 51 studies from the current update during the full-text screening process.The Characteristics of excluded studies table provides full details of the excluded studies.
As a result of the nature of the intervention, it was expected that blinding of participants and of professionals who delivered the interventions was not possible. Consequently, risk of performance bias in all studies was high. Risk of bias for other bias domains varied across included studies, and insufficient detail was provided to inform judgement in several included studies (see Figure 2, Risk of bias summary table, and Figure 3, Risk of bias graph, for an overview).
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
We judged 53 included studies as having low risk of bias in random sequence generation. Information was insufficient to permit a decision in relation to 12 trials (Bendstrup 1997; Borghi-Silva 2009; Clark 1996; Faager 2004; Fernandez 2009; Hoff 2007; Lindsay 2005; Mehri 2007; Nalbant 2011; Paz-Diaz 2007; Vijayan 2010; Wen 2008). With regard to allocation concealment, we judged 28 studies as having low risk of bias (Behnke 2000a; Booker 1984; Boxall 2005; Busch 1988; Cambach 1997; Casaburi 2004; Casey 2013; Cebollero 2012; Cochrane 2006; Cockcroft 1981; De Souto Araujo 2012; Emery 1998; Engström 1999; Faulkner 2010; Finnerty 2001; Goldstein 1994; Gomez 2006; Gosselink 2000; Gottlieb 2011; Griffiths 2000; Gurgun 2013; Karapolat 2007; Liu 2012; McNamara 2013; Mendes De Oliveira 2010; O'Shea 2007; Theander 2009; Van Wetering 2010) and four studies as having high risk of bias (Baumann 2012; Güell 1995; Güell 1998; Jones 1985); the remaining 33 studies provided insufficient information to inform judgements.
As a result of the nature of the intervention, it was not possible to blind participants or professionals who delivered the interventions. Consequently, we judged all studies as having high risk of performance bias.
Across studies, the level of reporting of whether outcome assessment was blinded was relatively poor. We judged 32 studies as having low risk of detection bias ( Barakat 2008; Booker 1984; Busch 1988; Casaburi 2004; Casey 2013; Cebollero 2012; Chan 2011; Cochrane 2006; De Souto Araujo 2012; Deering 2011; Elci 2008; Emery 1998; Engström 1999; Finnerty 2001; Goldstein 1994; Gomez 2006; Griffiths 2000; Güell 1995; Güell 1998; Hernandez 2000; Jones 1985; Lake 1990; Liu 2012; McNamara 2013; O'Shea 2007; Petty 2006; Reardon 1994; Ringbaek 2000; Simpson 1992; Strijbos 1996; Van Wetering 2010; Weiner 1992). In two of these studies (Engström 1999; Simpson 1992), the primary outcome assessment (quality of life) was blinded but the secondary outcome assessment (exercise capacity) was not. In Lake 1990, the cycle ergometer test was blinded, but the six-minute walk test was not. In Busch 1988, the cycle ergometer test was not blinded and the 12-minute walk test was blinded. Among studies that reported blinding of outcome assessment, nine studies were judged as having high risk of detection bias (Boxall 2005; Cambach 1997; Faulkner 2010; Gosselink 2000; Gottlieb 2011; McGavin 1977; Theander 2009; Vallet 1994; Wijkstra 1994), and the remaining 23 studies provided insufficient information to inform judgements.
We judged 39 studies as having low risk of attrition bias (Barakat 2008; Borghi-Silva 2009; Boxall 2005; Cambach 1997; Casaburi 2004; Chlumsky 2001; Cockcroft 1981; Emery 1998; Engström 1999; Fernandez 2009; Goldstein 1994; Griffiths 2000; Güell 1995; Güell 1998; Gurgun 2013; Hoff 2007; Karapolat 2007; Lake 1990; Lindsay 2005; Liu 2012; McGavin 1977; McNamara 2013; Mehri 2007; O'Shea 2007; Ozdemir 2010; Paz-Diaz 2007; Petty 2006; Reardon 1994; Ringbaek 2000; Simpson 1992; Singh 2003; Strijbos 1996; Theander 2009; Vallet 1994; Van Wetering 2010; Vijayan 2010; Weiner 1992; Wijkstra 1994; Xie 2003) and 22 as having high risk (Baumann 2012 24% of people dropped out; Behnke 2000a 35%; Bendstrup 1997 24%; Booker 1984 27%; Busch 1988 30%; Casey 2013 24%; Chan 2011 23%, Cochrane 2006 43%; De Souto Araujo 2012 24%; Deering 2011 42%; Faager 2004 30%; Faulkner 2010 30%; Finnerty 2001 43%; Gohl 2006 44%; Gomez 2006 48%; Gosselink 2000 62%; Gottlieb 2011 32%; Hernandez 2000 38%; Jones 1985 26%; Mendes De Oliveira 2010 27%; Nalbant 2011 28%; Wen 2008 24%). Information was insufficient to inform judgements in five studies (Cambach 1997; Cebollero 2012; Clark 1996; Elci 2008; Vijayan 2010).
We found no trial registration protocol for most studies to check whether all prespecified outcomes were reported in the articles. However, outcomes listed in the methods section of the included studies were reported in the results section, with the exception of four studies that were judged to have high risk of reporting bias (i.e. Ozdemir 2010, whose results for the CRQ are incomplete; Paz-Diaz 2007, who did not provide results for the rehabilitation group for CRQ; Petty 2006, in which results of the six-minute walk test and Short Form (SF)-36 are not presented; and Weiner 1992, in which results of the SGRQ are not available ). In relation to publication bias, we visually reviewed the funnel plots (Figure 1; Figure 4; Figure 5) and followed this by performing the Egger test (Egger 1997) (Table 1). Egger test results showed no significant publication bias across the studies included in the current meta-analysis.
Funnel plot of comparison: 1 Rehabilitation versus usual care, outcome: 1.4 QoL - Change in CRQ (Dyspnoea) (see Table 1 for Egger and Begg-Mazumdar: Kendall's test results).
Funnel plot of comparison: 1 Rehabilitation versus usual care, outcome: 1.5 QoL - Change in SGRQ (Total) (see Table 1 for Egger and Begg-Mazumdar: Kendall's test results).
We found no other source of bias, with the exception of a tendency toward increased proportions of male participants, as was highlighted earlier.
For this comparison, we included all participants who were randomly assigned in the included studies and received PR (defined as exercise training for at least four weeks with or without educational and/or psychological support) and those allocated to usual care (see Characteristics of included studies for details). We also undertook subgroup analysis as discussed in the Subgroup analysis and investigation of heterogeneity section. All outcomes results utilised in the analyses were based on baseline assessment measurements and the earliest follow-up assessment up to three months after completion of the intervention.
Among the 65 trials that met the inclusion criteria of the meta-analysis, 44 made an attempt to measure HRQoL using eight different strategies. Only three of these strategies - the Transitional Dyspnoea Index (TDI; Mahler 1984), the Chronic Respiratory Disease Questionnaire (CRQ; Guyatt 1987a) and the St. Georges Respiratory Questionnaire (SGRQ; Jones 1992) - have been demonstrated to be valid and responsive. Of these, the CRG and the SGRQ have become the recognised standard of assessment of HRQoL amongst patients with COPD and are reported here. We analysed the CRQ and the SGRQ separately. Not all subscales were fully completed by all participants, so the numbers of participants per outcome and per subscale varied.
Scores for the CRQ are reported on a 7-point scale. Although 23 studies utilised the CRQ to assess HRQoL, only 19 studies (1291 participants) provided results suitable for analysis.
Participants allocated to rehabilitation programmes had, on average, significantly greater changes in HRQoL CRQ scores across all subscales when compared with participants allocated to control groups (Fatigue: MD 0.68, 95% CI 0.45 to 0.92; 19 trials; 1291 participants; Tau² = 0.15; I² = 64%; Analysis 1.1; Emotional function: MD 0.56, 95% CI 0.34 to 0.78; 19 trials; 1291 participants; Tau² = 0.12; I² = 58%; Analysis 1.2; Mastery: MD 0.71, 95% CI 0.47 to 0.95; 19 trials; 1212 participants; Tau² = 0.16; I² = 63%; Analysis 1.3; Dyspnoea: MD 0.79, 95% CI 0.56 to 1.03; 19 trials; 1283 participants; Tau² = 0.15; I² = 63%; Analysis 1.4).
For each of the CRQ domains (dyspnoea, fatigue, emotional function and mastery), the common effect size exceeded the 'minimal clinically important difference' (MCID) (0.5 points on the 7-point scale) (Jaeschke 1989). The lower limit of the confidence interval around the common treatment effect of the dyspnoea domains (Analysis 1.4) exceeded the MCID, indicating not only statistical significance but also clinical significance in the effect of PR. The lower limits of the remaining domains were slightly below the MCID (Analysis 1.1; Analysis 1.2; Analysis 1.3).
Heterogeneity identified across all domains of the CRQ was substantial, as Tau² was greater than zero, and in all cases, I² was greater than 30% and the P value for the Chi² test was less than 0.10. We undertook subgroup and sensitivity analyses to try to explore heterogeneity; although findings are presented later, they did not explain the high level of heterogeneity.
Scores for the SGRQ are reported on a 100-point scale. Twenty trials utilised the SGRQ to assess the HRQoL of participants. Results were available in a usable format from 19 trials (a maximum of 1153 participants) for inclusion in the meta-analysis. Barakat 2008 was not included in the analysis, as clarification regarding the SD of the change is needed from the study authors.
Similar to the CRQ, participants allocated to PR programmes had, on average, significantly greater changes in SGRQ scores across all subscales when compared with participants allocated to control groups (SGRQ total: MD -6.89, 95% CI -9.26 to -4.52; 19 trials; 1146 participants; Tau² = 13.17; I² = 59%; Analysis 1.5; SGRQ symptoms: MD -5.09, 95% CI -7.69 to -2.49; 19 trials; 1153 participants; Tau² = 7.79; I² = 26%; Analysis 1.6; SGRQ impact: MD -7.23, 95% CI -9.91 to -4.55; 19 trials; 1149 participants; Tau² = 17.94; I² = 58%; Analysis 1.7; SGRQ activity: MD -6.08, 95% CI -9.28 to -2.88; 19 trials; 1148 participants; Tau² = 27.01; I² = 64%; Analysis 1.8).
For each of the SGRQ domains (as well as the total SGRQ score), the common effect size exceeded the MCID of four (Jones 1991; Quirk 1991) (Analysis 1.5; Analysis 1.6; Analysis 1.7; Analysis 1.8). All results of the analysis for all domains of the SGRQ were statistically significant. However, the extent of the 95% CI around the pooled treatment effect exceeds the MCID only for the SGRQ total and SGRQ impact domains of the SGRQ, demonstrating unequivocal clinical and statistical significance in these domains.
Heterogeneity in results obtained from the total and all subscales of the SGRQ was substantial, with the exception of the symptoms subscale (Analysis 1.6).
A total of 34 trials measured maximal exercise capacity. We limited the meta-analysis to the 16 trials that used the incremental cycle ergometer test.
Investigators in 16 studies (779 participants) used the incremental cycle ergometer test. On average, a statistically significant increase in mean Wmax (W) was reported among participants allocated to PR compared with those allocated to usual care (MD 6.77, 95% CI 1.89 to 11.65; Tau² = 40.97; I² = 74%; Analysis 1.10). The common effect size exceeded the MCID (4 watts) proposed by Puhan 2011(b). The maximal exercise test showed substantial heterogeneity in the results obtained.
Of the included studies, 43 trials used the six-minute walk test as an outcome. Of these, 38 (1879 participants: 1012 actively treated, 867 controls) presented the results in a format that could be used for the meta-analysis (see Analysis 1.11). Investigators reported a statistically significant increase, on average, in the mean difference in metres walked associated with PR (MD 43.93 m, 95% CI 32.64 to 55.21; Tau² = 713.49; I² = 74%; Analysis 1.11). Both the common effect and the lower limit of its confidence interval exceeded the MCID for the 6WMD of 30 metres, as recommended by Holland 2014, indicating the clinical significance of the effect of PR. .
Eight trials (694 participants) reported data on the incremental shuttle walk test (ISWT). These test results were analysed independently from those of the 6MWT. On average, a statistically significant increase in mean metres walked was noted among participants allocated to PR compared with those allocated to usual care (MD 39.77, 95% CI 22.38 to 57.15; Tau² = 181.56; I² = 32%). This result is slightly below the MCID of 47.5 m (Singh 2008; Singh 2014) to make this a finding of clinical significance.
Similar to previous outcomes on maximal exercise, both the six-minute walk test and the analyses demonstrated substantial heterogeneity.
Several other outcome measures were used to measure functional capacity, but because of the limited numbers of trials providing data for these other outcomes (endurance shuttle walk test: two trials; 12-minute walk test: four trials); four-minute walk test: one trial)), these findings were not included in the meta-analysis.
In total, 39 included studies were considered to have a hospital-based PR intervention delivered on an in-patient or out-patient basis. A total of 25 studies focused on programmes that were delivered in the community at community centres or in individuals' homes. One study had both a community-based and an out-patient-based intervention group, so it was excluded from the subgroup analysis (Mendes De Oliveira 2010).
In the subgroup analysis for the CRQ domain outcomes, the 'community' subgroup included nine studies (Cambach 1997; Casey 2013; Faulkner 2010; Gomez 2006; Hernandez 2000; Lindsay 2005; O'Shea 2007; Singh 2003; Wijkstra 1994) and the 'hospital group' included 10 studies (Behnke 2000a; Cebollero 2012; Goldstein 1994; Gosselink 2000; Griffiths 2000; Güell 1995; Güell 1998; McNamara 2013; Simpson 1992; Sridhar 2008; ). For SGRQ outcomes, the community subgroup included nine studies (Baumann 2012; Boxall 2005; Chan 2011; De Souto Araujo 2012; Elci 2008; Fernandez 2009; Gohl 2006; Gottlieb 2011; Van Wetering 2010) and the hospital subgroup included 10 studies (Chlumsky 2001; Deering 2011; Engström 1999; Finnerty 2001; Griffiths 2000; Gurgun 2013; Karapolat 2007; Paz-Diaz 2007; Ringbaek 2000; Theander 2009).
Evidence suggested a significant difference in treatment effect between subgroups for all domains of the CRQ, with higher mean values, on average, in the PR group in hospital than in the community-based group (Analysis 2.1; Analysis 2.2; Analysis 2.3; Analysis 2.4). No subgroup differences were reported for any of the SGRQ domains (Analysis 2.5; Analysis 2.6; Analysis 2.7; Analysis 2.8).
A total of 31 trials were included in the 'exercise only' subgroup, and 34 trials in the 'exercise plus more comprehensive components' subgroup, of which 10 trials in the 'exercise only' subgroup (Cebollero 2012; Gosselink 2000; Güell 1995; Güell 1998; Hernandez 2000; McNamara 2013; O'Shea 2007; Simpson 1992; Singh 2003; Sridhar 2008), and nine in the more comprehensive subgroup (Behnke 2000a; Cambach 1997; Casey 2013; Faulkner 2010; Goldstein 1994; Gomez 2006; Griffiths 2000; Lindsay 2005; Wijkstra 1994) reported CRQ data.
For the SGRQ, five trials were included in the 'exercise only' subgroup (Chan 2011; Chlumsky 2001; De Souto Araujo 2012; Gohl 2006; Paz-Diaz 2007) and 14 trials in the more comprehensive subgroup (Baumann 2012; Boxall 2005; Deering 2011; Elci 2008; Engström 1999; Fernandez 2009; Finnerty 2001; Gottlieb 2011; Griffiths 2000; Gurgun 2013; Karapolat 2007; Ringbaek 2000; Theander 2009; Van Wetering 2010).
No evidence was found of a significant treatment effect between subgroups for all domains of the CRQ (Analysis 3.1; Analysis 3.2; Analysis 3.3; Analysis 3.4) and the SGRQ (Analysis 3.5; Analysis 3.6; Analysis 3.7; Analysis 3.8).
Please see Table 4 for a summary of results of the subgroup analysis.
| |||||
| Pulmonary rehabilitation versus usual care. Subgroup: community versus hospital-delivered programme | |||||
| Outcome | Subscale | Subgroups | Heterogeneity | MD [95% CI] | Test for subgroup differences |
| CRQ | Fatigue | Community | Tau² = 0.10; I² = 52% | 0.44 [0.14, 0.75] | Chi² = 3.98, df = 1 (P value 0.05), I² = 74.9% |
| Hospital | Tau² = 0.09; I² = 51% | 0.86 [0.58, 1.14] | |||
| CRQ | Emotional Function | Community | Tau² = 0.00; I² = 0% | 0.21 [0.04, 0.39] | Chi² = 12.24, df = 1 (P value 0.0005), I² = 91.8% |
| Hospital | Tau² = 0.06; I² = 39% | 0.77 [0.51, 1.03] | |||
| CRQ | Mastery | Community | Tau² = 0.07; I² = 45% | 0.40 [0.12, 0.67] | Chi² = 8.58, df = 1 (P value 0.003), I² = 88.3% |
| Hospital | Tau² = 0.05; I² = 31% | 0.95 [0.70, 1.20] | |||
| CRQ | Dyspnoea | Community | Tau² = 0.03; I² = 26% | 0.58 [0.34, 0.81] | Chi² = 4.05, df = 1 (P value 0.04), I² = 75.3% |
| Hospital | Tau² = 0.17; I² = 60% | 0.99 [0.66, 1.32] | |||
| SGRQ | Total | Community | Tau² = 24.00; I² = 73% | -8.15 [-12.16, -4.13] | Chi² = 0.69, df = 1 (P value 0.41), I² = 0% |
| Hospital | Tau² = 6.41; I² = 35% | -6.05 [-8.91, -3.20] | |||
| SGRQ | Symptoms | Community | Tau² = 6.28; I² = 24% | -3.66 [-7.07, -0.24] | Chi² = 1.65, df = 1 (P value 0.20), I² = 39.2% |
| Hospital | Tau² = 4.96; I² = 15% | -6.91 [-10.51, -3.30] | |||
| SGRQ | Impact | Community | Tau² = 19.91; I² = 63% | -8.17 [-12.00, -4.34] | Chi² = 0.46, df = 1 (P value 0.50), I² = 0% |
| Hospital | Tau² = 22.39; I² = 58% | -6.21 [-10.33, -2.09] | |||
| SGRQ | Activity | Community | Tau² = 48.91; I² = 78% | -7.82 [-13.37, -2.28] | Chi² = 0.93, df = 1 (P value 0.33), I² = 0% |
| Hospital | Tau² = 10.45; I² = 36% | -4.58 [-8.16, -1.00] | |||
| Pulmonary rehabilitation versus usual care. Subgroup: exercise only programme versus exercise plus additional elements in programme | |||||
| Outcome | Subscale | Subgroups | Heterogeneity | MD [95% CI] | Test for subgroup differences |
| CRQ | Fatigue | Exercise only | Tau² = 0.00; I² = 0% | 0.73 [0.54, 0.92] | Chi² = 0.26, df = 1 (P value 0.61), I² = 0% |
| Exercise + other | Tau² = 0.29; I² = 79% | 0.61 [0.18, 1.03] | |||
| CRQ | Emotional Function | Exercise only | Tau² = 0.00; I² = 0% | 0.51 [0.31, 0.71] | Chi² = 0.09, df = 1 (P value 0.77), I² = 0% |
| Exercise + other | Tau² = 0.28; I² = 79% | 0.58 [0.16, 1.00] | |||
| CRQ | Mastery | Exercise only | Tau² = 0.01; I² = 11% | 0.66 [0.44, 0.88] | Chi² = 0.12, df = 1 (P value 0.73), I² = 0% |
| Exercise + other | Tau² = 0.31; I² = 79% | 0.74 [0.31, 1.18] | |||
| CRQ | Dyspnoea | Exercise only | Tau² = 0.06; I² = 31% | 0.83 [0.56, 1.10] | Chi² = 0.13, df = 1 (P value 0.72), I² = 0% |
| Exercise + other | Tau² = 0.25; I² = 77% | 0.74 [0.35, 1.13] | |||
| SGRQ | Total | Exercise only | Tau² = 62.83; I² = 70% | -7.87 [-16.72, 0.98] | |
| Exercise + other | Tau² = 10.17; I² = 56% | -6.76 [-9.19, -4.34] | Chi² = 0.06, df = 1 (P value 0.81), I² = 0% | ||
| SGRQ | Symptoms | Exercise only | Tau² = 0.00; I² = 0% | -7.38 [-12.33, -2.44] | |
| Exercise + other | Tau² = 13.88; I² = 41% | -4.38 [-7.62, -1.15] | Chi² = 0.99, df = 1 (P value 0.32), I² = 0% | ||
| SGRQ | Impact | Exercise only | Tau² = 33.34; I² = 63% | -6.11 [-12.60, 0.38] | |
| Exercise + other | Tau² = 17.12; I² = 59% | -7.61 [-10.64, -4.57] | Chi² = 0.17, df = 1 (P value 0.68), I² = 0% | ||
| SGRQ | Activity | Exercise only | Tau² = 139.67; I² = 78% | -9.33 [-21.66, 2.99] | Chi² = 0.30, df = 1 (P value 0.59), I² = 0% |
| Exercise + other | Tau² = 18.51; I² = 60% | -5.79 [-8.95, -2.64] | |||
A sensitivity analysis included only studies of high quality (studies for which both allocation concealment and Incomplete outcome data were rated as low risk) (see risk of bias table in Figure 2). Thirteen studies met the criteria for high quality (Boxall 2005; Cambach 1997; Cockcroft 1981; Emery 1998; Engström 1999; Goldstein 1994; Griffiths 2000; Karapolat 2007; Liu 2012; McNamara 2013; O'Shea 2007; Theander 2009; Van Wetering 2010). Effect estimates were consistent with overall summary effect estimates for the two primary outcomes when contributing data were restricted to high-quality studies, with the exception of one domain, for which the confidence interval widened enough to include the possibility of no difference between rehabilitation and control. All domains for both the CRQ and the SGRQ continued to be statistically significant when restricted to studies of high quality, with the exception of the SGRQ symptoms domain, which was no longer statistically significant (MD -4.12, 95% CI -8.42 to 0.21;, seven trials; 572 participants; Tau² = 13.82; I² = 46%).
Neither subgroup analyses nor the sensitivity analysis based on quality had any impact on reducing or explaining high levels of heterogeneity.
This review summarised 65 studies involving 3822 participants with chronic obstructive pulmonary disease (COPD), 2090 of whom were randomly allocated to some form of exercise rehabilitation for a minimum duration of four weeks, and 1732 individuals randomly assigned to usual care. This is the second update of this review, which was last updated in 2006 (Lacasse 2006). Pulmonary rehabilitation is now accepted within the scientific community as an essential strategy in the ongoing management of people with COPD (GOLD 2014). Development of objective health-related quality of life (HRQoL) outcome measures (Kirshner 1985) and demonstration of a physiological rationale for exercise training in people with COPD (Casaburi 1991; Maltais 1996) have facilitated this acceptance. Results of the previous version of this meta-analysis strongly supported pulmonary rehabilitation (PR) in the management of COPD, and results of this current update reconfirm these findings.
Three aspects of the meta-analysis warrant comment. First, we examined the short-term effects of PR in COPD, that is, the benefits of rehabilitation found at the completion of a programme. When the original review was undertaken, few investigators were examining the long-term benefits of rehabilitation (Guell 2000; Ries 1995; Troosters 2000; Wijkstra 1995). More recently, focus on this aspect of PR has increased and exploration of strategies to maintain early benefits continues (Brooks 2002; Foglio 2001; Ries 2003). This review does not attempt to examine these issues. Second, we have been conservative in concluding clear benefit only when the 95% confidence interval (CI) representing the smallest treatment effect was still greater than the minimal clinically important difference (MCID). Third, we excluded a number of well-conducted studies that have contributed to our understanding of PR, but in which control participants received interventions beyond what was considered conventional care. An example of this is Ries 1995, which was excluded on the grounds that control participants had been given an educational programme. Similarly, several studies in which an intervention such as inspiratory muscle training, psychosocial support or breathing exercises was compared with exercise training were excluded. Only studies in which usual care was directly compared with exercise rehabilitation were included for analysis.
As the care of patients with COPD is largely concerned with treating symptoms (Pauwels 2001), we believe that HRQoL should be considered as the primary outcome in PR. The present meta-analysis reconfirms the findings of the previous version that PR is effective in relieving dyspnoea and fatigue, and in improving patients' emotional function and control over the disease. The magnitude of the improvement lies beyond the MCID.
In most trials, investigators measured HRQoL by using either the Chronic Respiratory Disease Questionnaire (CRQ) or the St. George's Respiratory Questionnaire (SGRQ). Head-to-head comparisons of these questionnaires have been published (Harper 1997; Rutten-van Mölken 1999). In both studies, analyses of reliability, validity and responsiveness did not clearly favour one instrument above the other. Rutten-van Mölken and colleagues (Rutten-van Mölken 1999) suggested that the choice between the CRQ and the SGRQ should be based on other considerations, such as the required sample size. Only one trial included in the meta-analysis reported results from both the CRQ and the SGRQ (Griffiths 2000), with no clear indication that one questionnaire is more sensitive to change than the other. Therefore, comparisons from this meta-analysis are only indirect. We found wider 95% CIs around the pooled treatment effect from the SGRQ - a situation that may be explained by the smaller number of participants contributing to this analysis.
Pulmonary rehabilitation programmes included in the meta-analysis differed in several aspects, including clinical setting, duration and composition. This we believe is responsible for the substantial heterogeneity observed in the results obtained and is in keeping with a recent study by Spruit 2014 and supported by Rochester 2014, who also identified this as an issue requiring further investigation. For instance, the contributions of educational activities and psychological support to exercise training remain uncertain. This information would be of outmost importance to physicians and allied healthcare professionals who prescribe rehabilitation and to those who allocate the resources. We addressed this issue in a systematic overview of the literature (Lacasse 1997). Since the time this review was published, further evidence from randomised controlled trials (RCTs) has been published to better define the type and intensity of exercise (Bernard 1999), as well as the influence of programme components, including patient education and self-management (Bourbeau 2003), nutritional support (Steiner 2003) and respiratory muscle training (Watson 1997). Sometimes, evidence even took the form of systematic reviews (Ferreira 2012; Lotters 2002; Taylor 2005). Such questions were too specific to be directly addressed in this meta-analysis, which aimed to investigate the overall effect of rehabilitation in COPD (not the effects of its components). Nevertheless, homogeneity among study results suggested that less sophisticated rehabilitation programmes may also be effective in improving HRQoL, although the between-study comparison from which this conclusion follows is relatively weak.
Investigators have identified an increase in exercise tolerance and functional activities such as walking as other relevant outcomes of rehabilitation (Fishman 1994; Pauwels 2001). Our current interpretation of the results of the six-minute walk test (6MWT) analysis differs from that of the previous version of the meta-analysis (Lacasse 2006). In 2006, results of the meta-analysis were compared with an MCID of 54 metres (95% CI 37 to 71 metres; Redelmeier 1997). From this comparison, the clinical significance of results obtained from the 2006 meta-analysis was interpreted as uncertain. Since 2006, several studies have further investigated the issue of the MCID in field walk tests in chronic respiratory disease. Results of these studies have recently been summarised in an important systematic review, which was supported by the European Respiratory and American Thoracic Societies (Holland 2014; Singh 2014). Although variability across studies and methods used to determine the MCID is evident, available evidence suggests that the MCID for the 6MWT lies between 25 and 33 metres (median estimate 30 metres). Results of our meta-analysis (i.e. MD of 43.93 metres with 95% CI between 36.24 and 55.21 metres) indicate the clinical significance of the effects of PR.
When compared with the treatment effects of other important modalities of care for patients with COPD, such as long-acting inhaled therapy or oral theophylline and its new derivatives (Kew 2014 ; Ram 2005), rehabilitation resulted in greater improvement in important domains of HRQoL and functional exercise capacity.
The importance of measures of maximal exercise capacity remains to be defined. An initial test may be useful in assisting with the prescription of an appropriate level of training. Retesting may provide physiological evidence that a training response has occurred and may be useful in adjustment of intensity levels during the programme (Jones 1988). As the results of maximal exercise tests correlate poorly with those of HRQoL measures (Guyatt 1985; Wijkstra 1994a), maximal exercise testing cannot serve as a substitute for such measures when the outcome of a rehabilitation programme is evaluated.
Results of this meta-analysis strongly support pulmonary rehabilitation, including at least four weeks of exercise training, as part of the spectrum of treatment for patients with COPD. We found clinically and statistically significant improvements in important domains of health-related quality of life, including dyspnoea, fatigue, emotional function and mastery, in addition to the six-minute walk/distance test - a measure of functional exercise.
Pulmonary rehabilitation has long been underused in patients with COPD (Brooks 2007; Puhan 2011(a); Yohannes 2004). With the support of current international statements or clinical practice guidelines targeting respiratory rehabilitation in COPD (Bolton 2013; Nici 2006; Spruit 2013), we hope that the results of this meta-analysis will encourage the implementation of new programmes.
Overall, the conclusions of this meta-analysis are in agreement with those of prior meta-analyses published in 1996 and in 2001 (Lacasse 1996; Lacasse 2001). The addition of 34 RCTs since the 2006 update resulted, as expected, in narrowing of the CIs around the common effects of rehabilitation in the outcomes examined. This update continues to support the strong argument that PR is beneficial in improving HRQoL. It also reiterates the view presented in the 2006 update that additional RCTs comparing PR and conventional care in COPD are no longer warranted. However findings of the subgroup analysis undertaken as part of this update do stimulate new questions in relation to PR. The subgroup analysis finding that identified a difference in treatment effect between hospital-based programmes and community-based programmes suggests that further research should be undertaken to compare these two approaches. Similarly, the fact that the subgroup analysis identified no differences between basic exercise PR programmes and those that provided more complex interventions suggests the need to examine and identify the most essential components of PR programmes for achieving the best patient outcomes. Other factors that remain uncertain include the degree of supervision, the intensity of the training and how long the treatment effect persists. Recent recommendations provided by current guidelines from the ATS or ACSM that at least three weekly sessions are necessary for a treatment effect raise issues that require consideration beyond this current review. These specific issues demand further elucidation through RCTs and further meta-analysis.
We acknowledge the authors of the primary studies included in the meta-analysis, who have kindly provided additional data and information regarding their previous work. We acknowledge the contributions of Eric Wong, Roger Goldstein and Gordon Guyatt, who co-authored the initial version of this review. We would also like to thank Elizabeth Stovold (CAG Information Specialist) for conducting electronic literature searches, Emma Jackson for assisting with locating papers and Emma Welsh for providing assistance during the editorial process.
Yves Lacasse acknowledges Merck Frosst Canada, who funded a co-author, Sylvie Martin, to work on a previously published version of the review. At the time, the Cochrane Airways Group did not believe that this funding presented a threat to the validity of the Reviews' findings. Merck Frosst Canada was not otherwise involved in the design or conduct of this meta-analysis. We also acknowledge Nederlands Astma Fonds, Netherlands for funding for an earlier version of this review. No authors received funding for the 2015 update of the review.
John White was the Editor for this review and commented critically on the review.
The methods section of this review is based on a standard template used by the Cochrane Airways Group.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 QoL - Change in CRQ (Fatigue) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.68 [0.45, 0.92] |
| 2 QoL - Change in CRQ (Emotional Function) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.56 [0.34, 0.78] |
| 3 QoL - Change in CRQ (Mastery) | 19 | 1212 | Mean Difference (IV, Random, 95% CI) | 0.71 [0.47, 0.95] |
| 4 QoL - Change in CRQ (Dyspnoea) | 19 | 1283 | Mean Difference (IV, Random, 95% CI) | 0.79 [0.56, 1.03] |
| 5 QoL - Change in SGRQ (Total) | 19 | 1146 | Mean Difference (IV, Random, 95% CI) | -6.89 [-9.26, -4.52] |
| 6 QoL - Change in SGRQ (Symptoms) | 19 | 1153 | Mean Difference (IV, Random, 95% CI) | -5.09 [-7.69, -2.49] |
| 7 QoL - Change in SGRQ (Impacts) | 19 | 1149 | Mean Difference (IV, Random, 95% CI) | -7.23 [-9.91, -4.55] |
| 8 QoL - Change in SGRQ (Activity) | 19 | 1148 | Mean Difference (IV, Random, 95% CI) | -6.08 [-9.28, -2.88] |
| 9 Maximal Exercise (Incremental shuttle walk test) | 8 | 694 | Mean Difference (IV, Random, 95% CI) | 39.77 [22.38, 57.15] |
| 10 Maximal Exercise Capacity (cycle ergometer) | 16 | 779 | Mean Difference (IV, Random, 95% CI) | 6.77 [1.89, 11.65] |
| 11 Functional Exercise Capacity (6MWT)) | 38 | 1879 | Mean Difference (IV, Random, 95% CI) | 43.93 [32.64, 55.21] |
Comparison 1 Rehabilitation versus usual care, Outcome 1 QoL - Change in CRQ (Fatigue).
Comparison 1 Rehabilitation versus usual care, Outcome 2 QoL - Change in CRQ (Emotional Function).
Comparison 1 Rehabilitation versus usual care, Outcome 3 QoL - Change in CRQ (Mastery).
Comparison 1 Rehabilitation versus usual care, Outcome 4 QoL - Change in CRQ (Dyspnoea).
Comparison 1 Rehabilitation versus usual care, Outcome 5 QoL - Change in SGRQ (Total).
Comparison 1 Rehabilitation versus usual care, Outcome 6 QoL - Change in SGRQ (Symptoms).
Comparison 1 Rehabilitation versus usual care, Outcome 7 QoL - Change in SGRQ (Impacts).
Comparison 1 Rehabilitation versus usual care, Outcome 8 QoL - Change in SGRQ (Activity).
Comparison 1 Rehabilitation versus usual care, Outcome 9 Maximal Exercise (Incremental shuttle walk test).
Comparison 1 Rehabilitation versus usual care, Outcome 10 Maximal Exercise Capacity (cycle ergometer).
Comparison 1 Rehabilitation versus usual care, Outcome 11 Functional Exercise Capacity (6MWT)).
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 QoL - Change in CRQ (Fatigue) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.68 [0.45, 0.92] |
| 1.1 QoL - Community CRQ (Fatigue) | 9 | 648 | Mean Difference (IV, Random, 95% CI) | 0.44 [0.14, 0.75] |
| 1.2 QoL - Hospital CRQ (Fatigue) | 10 | 643 | Mean Difference (IV, Random, 95% CI) | 0.86 [0.58, 1.14] |
| 2 QoL - Change in CRQ (Emotional Function) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.56 [0.34, 0.78] |
| 2.1 QoL - Community (Emotional Function) | 9 | 648 | Mean Difference (IV, Random, 95% CI) | 0.21 [0.04, 0.39] |
| 2.2 QoL - Hospital CRQ (Emotional Function) | 10 | 643 | Mean Difference (IV, Random, 95% CI) | 0.77 [0.51, 1.03] |
| 3 QoL - Change in CRQ (Mastery) | 19 | 1212 | Mean Difference (IV, Random, 95% CI) | 0.71 [0.47, 0.95] |
| 3.1 QoL - Community CRQ (Mastery) | 9 | 569 | Mean Difference (IV, Random, 95% CI) | 0.40 [0.12, 0.67] |
| 3.2 QoL - Hospital CRQ (Mastery) | 10 | 643 | Mean Difference (IV, Random, 95% CI) | 0.95 [0.70, 1.20] |
| 4 QoL - Change in CRQ (Dyspnoea) | 19 | 1283 | Mean Difference (IV, Random, 95% CI) | 0.82 [0.59, 1.05] |
| 4.1 QoL - Community Based CRQ (Dyspnoea) | 8 | 633 | Mean Difference (IV, Random, 95% CI) | 0.58 [0.34, 0.81] |
| 4.2 QoL - Hospital Based CRQ (Dyspnoea) | 11 | 650 | Mean Difference (IV, Random, 95% CI) | 0.99 [0.66, 1.32] |
| 5 QoL - Change in SGRQ (Total) | 19 | 1146 | Mean Difference (IV, Random, 95% CI) | -6.89 [-9.26, -4.52] |
| 5.1 QoL - Community in SGRQ (Total) | 9 | 643 | Mean Difference (IV, Random, 95% CI) | -8.15 [-12.16, -4.13] |
| 5.2 QoL - Hospital SGRQ (Total) | 10 | 503 | Mean Difference (IV, Random, 95% CI) | -6.05 [-8.91, -3.20] |
| 6 QoL - Change in SGRQ (Symptoms) | 19 | 1153 | Mean Difference (IV, Random, 95% CI) | -5.09 [-7.69, -2.49] |
| 6.1 QoL - Community SGRQ (Symptoms) | 9 | 649 | Mean Difference (IV, Random, 95% CI) | -3.66 [-7.07, -0.24] |
| 6.2 QoL - Hospital SGRQ (Symptoms) | 10 | 504 | Mean Difference (IV, Random, 95% CI) | -6.91 [-10.51, -3.30] |
| 7 QoL - Change in SGRQ (Impacts) | 19 | 1149 | Mean Difference (IV, Random, 95% CI) | -7.23 [-9.91, -4.55] |
| 7.1 QoL - Community SGRQ (Impacts) | 9 | 646 | Mean Difference (IV, Random, 95% CI) | -8.17 [-10.00, -4.34] |
| 7.2 QoL - Hospital SGRQ (Impacts) | 10 | 503 | Mean Difference (IV, Random, 95% CI) | -6.21 [-10.33, -2.09] |
| 8 QoL - Change in SGRQ (Activity) | 19 | 1148 | Mean Difference (IV, Random, 95% CI) | -6.08 [-9.28, -2.88] |
| 8.1 QoL - Community SGRQ (Activity) | 9 | 645 | Mean Difference (IV, Random, 95% CI) | -7.82 [-13.37, -2.28] |
| 8.2 QoL - Hospital SGRQ (Activity) | 10 | 503 | Mean Difference (IV, Random, 95% CI) | -4.58 [-8.16, 1.00] |
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 1 QoL - Change in CRQ (Fatigue).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 2 QoL - Change in CRQ (Emotional Function).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 3 QoL - Change in CRQ (Mastery).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 4 QoL - Change in CRQ (Dyspnoea).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 5 QoL - Change in SGRQ (Total).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 6 QoL - Change in SGRQ (Symptoms).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 7 QoL - Change in SGRQ (Impacts).
Comparison 2 Rehabilitation versus usual care (subgroup analysis hospital vs community), Outcome 8 QoL - Change in SGRQ (Activity).
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 QoL - Change in CRQ (Fatigue) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.68 [0.45, 0.92] |
| 1.1 QoL - Exercise Only CRQ (Fatigue) | 10 | 480 | Mean Difference (IV, Random, 95% CI) | 0.73 [0.54, 0.92] |
| 1.2 QoL - Exercise + Other CRQ (Fatigue) | 9 | 811 | Mean Difference (IV, Random, 95% CI) | 0.61 [0.18, 1.03] |
| 2 QoL - Change in CRQ (Emotional Function) | 19 | 1291 | Mean Difference (IV, Random, 95% CI) | 0.56 [0.34, 0.78] |
| 2.1 QoL - Exercise Only CRQ (Emotional Function) | 10 | 480 | Mean Difference (IV, Random, 95% CI) | 0.51 [0.31, 0.71] |
| 2.2 QoL - Exercise + Other CRQ (Emotional Function) | 9 | 811 | Mean Difference (IV, Random, 95% CI) | 0.58 [0.16, 1.00] |
| 3 QoL - Change in CRQ (Mastery) | 19 | 1212 | Mean Difference (IV, Random, 95% CI) | 0.71 [0.47, 0.95] |
| 3.1 QoL - Exercise Only CRQ (Mastery) | 10 | 480 | Mean Difference (IV, Random, 95% CI) | 0.66 [0.44, 0.88] |
| 3.2 QoL - Exercise + Other CRQ (Mastery) | 9 | 732 | Mean Difference (IV, Random, 95% CI) | 0.74 [0.31, 1.18] |
| 4 QoL - Change in CRQ (Dyspnoea) | 19 | 1283 | Mean Difference (IV, Random, 95% CI) | 0.79 [0.56, 1.03] |
| 4.1 QoL - Exercise Only CRQ (Dyspnoea) | 10 | 474 | Mean Difference (IV, Random, 95% CI) | 0.83 [0.56, 1.09] |
| 4.2 QoL - Exercise + Other CRQ (Dyspnoea) | 9 | 809 | Mean Difference (IV, Random, 95% CI) | 0.74 [0.35, 1.13] |
| 5 QoL - Change in SGRQ (Total) | 19 | 1146 | Mean Difference (IV, Random, 95% CI) | -6.89 [-9.26, -4.52] |
| 5.1 QoL Exercise Only SGRQ (Total) | 5 | 230 | Mean Difference (IV, Random, 95% CI) | -7.87 [-16.72, 0.98] |
| 5.2 QoL Exercise + Other SGRQ (Total) | 14 | 916 | Mean Difference (IV, Random, 95% CI) | -6.76 [-9.19, -4.34] |
| 6 QoL - Change in SGRQ (Symptoms) | 19 | 1153 | Mean Difference (IV, Random, 95% CI) | -5.09 [-7.69, -2.49] |
| 6.1 QoL - Exercise Only SGRQ (Symptoms) | 5 | 230 | Mean Difference (IV, Random, 95% CI) | -7.38 [-12.33, -2.44] |
| 6.2 QoL - Exercise + Other SGRQ (Symptoms) | 14 | 923 | Mean Difference (IV, Random, 95% CI) | -4.38 [-7.62, -1.15] |
| 7 QoL - Change in SGRQ (Impacts) | 19 | 1149 | Mean Difference (IV, Random, 95% CI) | -7.23 [-9.91, -4.55] |
| 7.1 QoL - Exercise Only SGRQ (Impacts) | 5 | 230 | Mean Difference (IV, Random, 95% CI) | -6.11 [-12.60, 0.38] |
| 7.2 QoL - Exercise + Other SGRQ (Impacts) | 14 | 919 | Mean Difference (IV, Random, 95% CI) | -7.61 [-10.64, -4.57] |
| 8 QoL - Change in SGRQ (Activity) | 19 | 1148 | Mean Difference (IV, Random, 95% CI) | -6.08 [-9.28, -2.88] |
| 8.1 QoL - Exercise Only SGRQ (Activity) | 5 | 230 | Mean Difference (IV, Random, 95% CI) | -9.33 [-21.66, 2.99] |
| 8.2 QoL - Exercise + Other SGRQ (Activity) | 14 | 918 | Mean Difference (IV, Random, 95% CI) | -5.79 [-8.95, -2.64] |
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 1 QoL - Change in CRQ (Fatigue).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 2 QoL - Change in CRQ (Emotional Function).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 3 QoL - Change in CRQ (Mastery).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 4 QoL - Change in CRQ (Dyspnoea).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 5 QoL - Change in SGRQ (Total).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 6 QoL - Change in SGRQ (Symptoms).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 7 QoL - Change in SGRQ (Impacts).
Comparison 3 Rehabilitation versus usual care (subgroup analysis exercise only vs exercise and other), Outcome 8 QoL - Change in SGRQ (Activity).
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 QoL - Change in CRQ (Dyspnoea) | 5 | 384 | Mean Difference (IV, Random, 95% CI) | 0.99 [0.64, 1.34] |
| 1.1 QoL - Low Risk CRQ (Dyspnoea) | 5 | 384 | Mean Difference (IV, Random, 95% CI) | 0.99 [0.64, 1.34] |
| 2 QoL - Change in CRQ (Emotional Function) | 5 | 386 | Mean Difference (IV, Random, 95% CI) | 0.60 [0.09, 1.11] |
| 2.1 QoL - Low Risk (Emotional Function) | 5 | 386 | Mean Difference (IV, Random, 95% CI) | 0.60 [0.09, 1.11] |
| 3 QoL - Low Risk CRQ (Fatigue) | 5 | 386 | Mean Difference (IV, Random, 95% CI) | 0.90 [0.41, 1.39] |
| 4 QoL - Low Risk CRQ (Mastery) | 5 | 386 | Mean Difference (IV, Random, 95% CI) | 0.77 [0.28, 1.26] |
| 5 QoL - Low Risk SGRQ (Total) | 7 | 572 | Mean Difference (IV, Random, 95% CI) | -5.15 [-7.95, -2.36] |
| 6 QoL - Low Risk SGRQ (Symptoms) | 7 | 572 | Mean Difference (IV, Random, 95% CI) | -4.12 [-8.45, 0.21] |
| 7 QoL - Low Risk SGRQ (Impacts) | 7 | 572 | Mean Difference (IV, Random, 95% CI) | -5.92 [-10.01, -1.82] |
| 8 QoL - Low Risk SGRQ (Activity) | 7 | 572 | Mean Difference (IV, Random, 95% CI) | -5.33 [-8.10, -2.57] |
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 1 QoL - Change in CRQ (Dyspnoea).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 2 QoL - Change in CRQ (Emotional Function).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 3 QoL - Low Risk CRQ (Fatigue).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 4 QoL - Low Risk CRQ (Mastery).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 5 QoL - Low Risk SGRQ (Total).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 6 QoL - Low Risk SGRQ (Symptoms).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 7 QoL - Low Risk SGRQ (Impacts).
Comparison 4 Rehabilitation versus usual care (sensitivity analysis by allocation concealment and incomplete outcome), Outcome 8 QoL - Low Risk SGRQ (Activity).
Search strategy used for review versions published up to 2004
We searched all records in the Cochrane Airways Group Register coded as 'COPD' for original articles published in any language using the following strategy: rehabilitat* or fitness* or exercis* or physical* or train*
In the first version of this review (Lacasse 1996), 522 publications were retrieved from the computerised search. The review authors reduced this list to 68 potentially eligible papers (quadratic weighted Kappa 0.53, 95% CI 0.45 to 0.61) that were assessed in detail. From this study list, 47 were excluded as the result of wrong population studies (n = 4), intervention not meeting the definition of rehabilitation (n = 7), control group not receiving conventional community care (n = 29), trials not randomised (n = 7). Both primary review authors agreed to include 17 papers in the meta-analysis (quadratic Kappa 0.89, 95% CI 0.65 to 1.00). Six of the 14 RCTs included in the original meta-analysis (Lacasse 1996) were not uncovered by this literature search. Therefore, a total of 23 randomised controlled trials were included. This represents an addition of nine RCTs to the meta-analysis published in 1996 (Lacasse 1996). We contacted the authors of these trials for any additional information required; response rate was 91% (21/23).
An updated search for the review was undertaken in October 2004, which identified an additional 998 references. These were filtered to a list of 139 references, which were considered in the update of the review. Of these, 93 studies failed to meet the inclusion criteria. The original version of the review as previously indicated had included 23 trials. From the updated search (2004), eight additional RCTs (represented by 17 references) met the inclusion criteria of the review (Behnke 2000a; Boxall 2005; Casaburi 2004; Chlumsky 2001; Finnerty 2001; Güell 1998; Singh 2003; Xie 2003). Six papers were awaiting assessment (Corrado 1995: published as conference abstract; Fernández 1998: paper not available; Shu 1998: published as conference abstract; Tregonning 2000: published as conference abstract; Ward 1999: published as conference abstract; Wright 2002: unclear study methods). One trial was ongoing (Whiteford 2004). As an outcome of the update in 2004, a total of 31 RCTs (represented by 65 references) contributed to the meta-analysis.
| Database | Frequency of search |
| CENTRAL | Monthly |
| MEDLINE (Ovid) | Weekly |
| EMBASE (Ovid) | Weekly |
| PsycINFO (Ovid) | Monthly |
| CINAHL (EBSCO) | Monthly |
| AMED (EBSCO) | Monthly |
| Conference | Years searched |
| American Academy of Allergy, Asthma and Immunology (AAAAI) | 2001 onwards |
| American Thoracic Society (ATS) | 2001 onwards |
| Asia Pacific Society of Respirology (APSR) | 2004 onwards |
| British Thoracic Society Winter Meeting (BTS) | 2000 onwards |
| Chest Meeting | 2003 onwards |
| European Respiratory Society (ERS) | 1992, 1994, 2000 onwards |
| International Primary Care Respiratory Group Congress (IPCRG) | 2002 onwards |
| Thoracic Society of Australia and New Zealand (TSANZ) | 1999 onwards |
1. Lung Diseases, Obstructive/
2. exp Pulmonary Disease, Chronic Obstructive/
3. emphysema$.mp.
4. (chronic$ adj3 bronchiti$).mp.
5. (obstruct$ adj3 (pulmonary or lung$ or airway$ or airflow$ or bronch$ or respirat$)).mp.
6. COPD.mp.
7. COAD.mp.
8. COBD.mp.
9. AECB.mp.
10. or/1-9
1. exp "clinical trial [publication type]"/
2. (randomised or randomised).ab,ti.
3. placebo.ab,ti.
4. dt.fs.
5. randomly.ab,ti.
6. trial.ab,ti.
7. groups.ab,ti.
8. or/1-7
9. Animals/
10. Humans/
11. 9 not (9 and 10)
12. 8 not 11
The MEDLINE strategy and RCT filter are adapted to identify trials in other electronic databases
#1 MeSH DESCRIPTOR Pulmonary Disease, Chronic Obstructive Explode All
#2 MeSH DESCRIPTOR Bronchitis, Chronic
#3 (obstruct*) near3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)
#4 COPD:MISC1
#5 (COPD OR COAD OR COBD):TI,AB,KW
#6 #1 OR #2 OR #3 OR #4 OR #5
#7 MeSH DESCRIPTOR Rehabilitation
#8 MeSH DESCRIPTOR Respiratory Therapy
#9 rehabilitat*
#10 fitness*
#11 exercis*
#12 train*
#13 #7 or #8 or #9 or #10 or #11 or #12
#14 #6 and #13
[Note: in search line #4, MISC1 denotes the field in which the reference has been coded for condition, in this case, COPD]
| Exclusion criteria |
| Less than 90% of participants have a diagnosis of COPD |
| Not a programme, or programme does NOT contain any exercise component |
| Has an exercise component but is NOT aerobically demanding |
| Programme of less than 4 weeks' duration |
| Control received more than conventional care |
| Includes ventilated patients (hospital ventilated) |
| Within 4 weeks post exacerbation |
| This citation linked to main study paper already being screened |
| Duplicate citation (identical to a citation previously included) |
| The intervention is a medication |
| Classification | Action |
| Excluded | Study excluded |
| Important article but not to be included in review | Study excluded |
| Included but needs translation | Study included and proceeds to next stage |
| Included | Study included and proceeds to next stage |
| More information needed before inclusion decision | Awaiting additional information before study proceeds |
A detailed description of the methods used to generate the allocation sequence was developed for each study to facilitate an assessment of whether it should produce comparable groups.
Risk of bias for sequence generation was graded based on the following:
low risk (any truly random process, e.g. random number table; computer random number generator);
high risk (any non-random process, e.g. odd or even date of birth; hospital or clinic record number); or
unclear risk.
A description of the methods used to conceal the allocation sequence for each study was presented, and this determined whether the intervention allocation might have been anticipated in advance of, or during, recruitment, or changed after assignment.
Risk of bias associated with allocation concealment was graded as follows:
low risk (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
high risk (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth); or
unclear risk.
The nature of the interventions involved in pulmonary rehabilitation would make it highly unlikely or impossible to blind participants or personnel delivering the interventions.
However, it would be possible to blind outcome assessors. Therefore, we assessed the risk of bias for blinding of outcome assessors as:
high risk;
low risk; or
unclear risk.
We will describe for each included study the methods used, if any, to blind outcome assessors from knowledge
of which intervention participants received. We will assess the risk of bias for blinding of outcome assessment as:
low risk;
high risk; or
unclear risk.
A description of completeness of data for each outcome at all stages of the study was presented. This included examining attrition and exclusions from the analysis. Each study was examined to identify whether attrition and exclusions were reported (comparing the numbers presented at each stage with the total number of randomised participants). The studies were also examined for rationale and justifications explaining any attrition or exclusions. In instances where enough information could be identified or was obtained from the trial authors, we re-included missing data in the analyses. We assessed the risk of bias for completeness of data as follows:
low risk (20% or less missing data);
high risk (more than 20% missing data); or
unclear risk.
Studies were examined for selective outcome reporting bias by cross-checking that all outcomes identified in the methods section of the results publication were reported in the results section of the trial publication(s).
The risk of bias for selective reporting was graded as follows:
high risk (where not all of the study’s prespecified outcomes had been reported; one or more reported primary outcomes were not prespecified; outcomes of interest were reported incompletely and so cannot be used; study failed to include results of a key outcome that would have been expected to have been reported);
low risk (where it was clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported); or
unclear risk.
If the review authors believed that any other possible sources of bias were matters of concern, these were recorded.
The level at which studies were seen to be free of other problems that could put them at risk of bias was graded as:
low risk;
high risk; or
unclear risk.
An overall judgement was made in relation to whether studies were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and identified above. The magnitude of the overall bias, along with the degree to which the bias was likely to have impacted the findings, was assessed for each study using the following grades:
low risk;
high risk; or
unclear risk.
| Date | Event | Description |
|---|---|---|
| 21 April 2015 | Amended | Typo in CI for functional exercise capacity in results corrected. |
Protocol first published: Issue 1, 1998
Review first published: Issue 1, 2003
| Date | Event | Description |
|---|---|---|
| 26 March 2014 | New citation required and conclusions have changed | New author team Abstract, plain language summary and results redrafted. Inclusion criteria modified and outcomes defined. Methods brought up to date, including use of current Cochrane risk of bias tool. Summary of findings table added Conclusions strengthened through the addition of 35 new studies, and recommendations for future research modified Only assessments completed up to and within 3 months of completion of the intervention included in the analysis Studies that commenced within 4 weeks of an acute exacerbation of COPD excluded, as a separate systematic review examined the effects of pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease (Puhan 2011) Additional subgroup analysis undertaken |
| 26 March 2014 | New search has been performed | New literature search run |
| 20 August 2008 | Amended | Converted to new review format |
| 16 June 2006 | New citation required and conclusions have changed | Substantive amendments made |
BMC and DC selected trials.
BMC, DC, EM and KM extracted data.
BMC, DC, EM, DD and KM assessed the methodological quality of trials.
BMC was responsible for handling data in RevMan.
BMC and DD designed the meta-analysis.
BMC and DD completed the clinical interpretation of results.
YL provided support and guidance throughout the update and critically reviewed the final manuscript.
The review authors DC, BMC, KM and DD were involved in the PRINCE study conducted by Casey 2013, a cluster-randomised trial that was included in this review. The risk of bias table for this study was therefore completed by two independent review authors, who were not involved in this trial but were experienced in conducting Cochrane systematic reviews. These were the review authors EM and Miriam Brennan, Lecturer at the School of Nursing & Midwifery, NUI Galway.
In this current update, the following changes were made from the previous version.
We made the following changes to the inclusion and exclusion criteria.
We excluded randomised controlled trials that focused on participants:
who were ventilated; or
who had an acute exacerbation within four weeks before commencement of the intervention
We excluded interventions for which the physical activity component was considered to not be aerobically demanding (such as respiratory muscle training, breathing exercises, Tai Chi and yoga). The degree of aerobic demand was assessed for each individual intervention by examining the detailed description of the intervention in identified studies. We also excluded programmes of less than four weeks' duration.
We clarified what was considered usual care.
| Methods | Study design: RCT "Randomization was in blocks of 10, using random numbers" (pg 157) | |
| Participants | Setting: out-patients in France Inclusion criteria:
Exclusion criteria:
Participant status: Age, years: RG: 63.7; CG: 65.9 Gender (M/F): 67/13 FEV1 % predicted: RG: 41.9; CG: 43.3 Participants randomly assigned: Randomised: 80 Analysed Rehab: 35 | |
| Interventions | Pulmonary rehabilitation: Out-patient-based rehabilitation ULE, LLE, Edu Duration: 14-Week programme | |
| Outcomes | Assessed: baseline and 14 weeks Spirometry, SGRQ, 6MWT, Bode Index | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was in blocks of 10, using random numbers" (pg 157) |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The nature of the intervention made it impossible to blind participants to their allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All tests including SGRQ outcome assessment [were] blinded" (pg 150) "All of these tests were supervised by a blinded observer, who subsequently repeated this assessment before the study and at the end of the study (0 and 14 weeks)" (pg 156) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 80; completed: 71; attrition: 11.25% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: prospective, randomised, controlled, interventional, multi-centre trial | |
| Participants | Setting: Hamburg metropolitan area, multi-centre trial Inclusion criteria:
Exclusion criteria:
Participant status: Age, years: RG: 65; CG: 63 Gender (M/F): 47/34 FEV1 % predicted: RG: 45; CG:47 Participants randomly assigned: Randomised: 100 Analysed Rehab: 37 | |
| Interventions | Pulmonary rehabilitation: Out-patient (hospital based) Aerobic exercise, ULE, LLE Edu, peer support Duration: 8 sessions of 20 minutes and 18 sessions of 60 minutes Usual care: Standard care consisted of referral back to the participant’s pulmonologist following baseline assessments. The control group did not take part in any components of the rehabilitation programme | |
| Outcomes | Assessed: baseline and 6 months 6-Minute walk test (6MWT) Cycle ergometry Short Form-12 (SF-12), SGRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was performed using a computer-generated list of random numbers to assign participants to either training or standard care" (pg 3) |
| Allocation concealment (selection bias) | High risk | "Consecutive patients with COPD according to accepted criteria [5] were recruited" (pg 3) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Due to the nature of the intervention it was not possible to blind subjects to their allocation (pg 2) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Those supervising the 6MWT were not blinded, whereas those supervising cycle ergometry were blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 42; completed: 32; attrition: 10 (24%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT | |
| Participants | Setting: work undertaken in Germany Inclusion criteria:
Exclusion criteria:
Participant status: Age, (years± SD): RG: 64.0 ± 1.9; CG: 68.0 ± 2.2 Gender (M/F): RG: 12/3; CG: 11/4 FEV1 % predicted (± SD): RG: 34.1 ± 7.4; 37.5 ± 6.6 Participants randomly assigned: In-patient and home-based | |
| Interventions | Pulmonary rehabilitation: acute hospital admission followed by home exercise programme for 6 months LLE, Edu, Psy Usual care: Control participants were advised to perform exercise but without special instructions | |
| Outcomes | Assessment: baseline and 3, 6 months 6MWT, CRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was in blocks of 10, using random numbers (from study authors) |
| Allocation concealment (selection bias) | Low risk | Randomisation process: sealed envelopes (from study authors) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the programme knew the allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Does not provide information on blinding of assessors, other than that main researcher undertook assessments "the questionnaire was administered as a structured interview, and all interviews were performed by the same investigator (M.B.)" (pg 11867) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced :46; completed: 30; attrition:16 (35%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None reported |
| Methods | Study design: RCT | |
| Participants | Setting: Patients came for out-patient rehabilitation to a hospital in Denmark Inclusion criteria:
Exclusion criteria:
Participant status: Age, (years ± SD): RG: 64 ± 3; CG: 65 ± 2 Gender (M/F): RG: 7/9; CG: 7/9 Participants randomly assigned: Randomised: 42 | |
| Interventions | Pulmonary rehabilitation: out-patient LLE, ULE, IMT Control: Stated that care was provided by primary physician | |
| Outcomes | Assessment: baseline and 12 weeks 6MWT, CRQ, activities of daily living, York QLQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided other than this: "The patients were randomly allocated to either an intervention or a control group" |
| Allocation concealment (selection bias) | Unclear risk | Information not available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the programme knew the allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided in relation to blinding of those carrying out outcome assessments |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 42; completed: 32; attrition: 10 (24%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT | |
| Participants | Setting: home-based UK study in London Inclusion criteria:
Exclusion criteria:
Participant status: Age, (years±SD) : RG: 66± 8; CG: 65 ± 7 Gender: not available Participants randomly assigned: Randomised: 69 | |
| Interventions | Pulmonary rehabilitation: LLE, BE, PD, Edu, Psy | |
| Outcomes | Assessment: baseline and 3, 6, 12 months 6MWT, DSSI/SAD, daily activity questionnaire | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: coin toss |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the programme knew the allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All assessments were carried out by independent assessors who were unaware of the treatment received by each participant - "double-blind" (pg 258) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 128; completed: 94 (73%); attrition: 27% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: prospective randomised controlled trial | |
| Participants | Setting: Brazil Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: 67 ±10; CG: 67 ± 10 Gender (M/F): RG: 13/7; CG: 12/8 FEV1 % predicted (± SD): RG: 64 ± 16; CG: 64 ± 18 Participants randomly assigned: Randomised: 40 Analysed: Rehab: 20 | |
| Interventions | Pulmonary rehabilitation: Out-patient (hospital-based) supervised training programme Aerobic exercise, ULE, LLE Duration: 6-week programme Usual care | |
| Outcomes | Assessed: baseline and 6 weeks 6-Minute walk ReR intervals | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information available |
| Allocation concealment (selection bias) | Unclear risk | No information available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind because of the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information available |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 40; completed: 34; attrition: 6 (15%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Unclear risk | None noted |
| Methods | Study design: RCT | |
| Participants | Setting: home-based PR programme in Australia Inclusion criteria:
Exclusion criteria:
Participant status: Gender (M/F): RG: 11/12; CG: 15/8 Age (years±SD): RG: 77.6 ±7.6; CG: 75.8 ±8.1 FEV1 % predicted (± SD): RG: 40.5 ±15.9; CG: 37.7 ±15.0 FEV1/FVC % predicted (± SD): RG: 74.4 ± 21.3; CG: 70.4 ± 19.2 Participants randomly assigned: Randomised: 60 | |
| Interventions | Pulmonary rehabilitation: supervised home-based ULE, LLE, Edu Usual care: Control phase: Participants received no treatment in addition to usual medical care | |
| Outcomes | Assessed: baseline and 12 weeks 6MWT, SGRQ, dyspnoea | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer-generated random numbers that were coded into opaque envelopes by a person independent from the study, they retained the envelopes until initial assessment was completed" (pg 380) |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group: "computer-generated random numbers that were coded into opaque envelopes by a person independent from the study, they retained the envelopes until initial assessment was completed" (pg 380) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Neither assessors nor participants were blinded to group assignment in this study" (pg 380) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "Neither assessors nor participants were blinded to group assignment in this study" (pg 380) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 60; completed: 46 (76.7%); attrition: 23.3% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | High risk | "Had to live locally might bias the sample selection and be motivated to exercised daily" (pg 379) |
| Methods | Study design: RCT stratified in a random manner | |
| Participants | Setting: home-based; Saskatchewan, Canada Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 65 ±16; CG: 66 ±16 Gender (M/F): RG: 5/2; CG: 6/1 FEV1 (± SD): RG: 26% ± 9; CG: 27% ±11 Participants randomly assigned: Randomised: 14 | |
| Interventions | Pulmonary rehabilitation: LLE, BE Usual care: Control group visited but did not follow the exercise programme | |
| Outcomes | Assessment: baseline and at 18 weeks CRQ (dyspnoea only), ICET, multi-step stage test | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Letter received from study author: used a table of random numbers |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention were aware of those allocated to the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | “The testers did not know whether the patients were assigned to the Exercise Group or the Control Group" (pg 470) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 20; completed: 14; attrition: 6 (30%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Unclear risk | None noted |
| Methods | Study design: RCT | |
| Participants | Setting: 8 community-based local physiotherapy practices in The Netherlands Inclusion criteria:
Exclusion criteria:
Participant status: Age, (years± SD): RG: 62 ± 5; CG: 62 ± 9 Gender (M/F): RG: 7/8; CG: 6/2 FEV1 % predicted (± SD): RG: 59% ± 16; CG: 60% ± 23 Participants randomly assigned: Randomised: 99 | |
| Interventions | Pulmonary rehabilitation: community based LLE, ULE, Edu, IMT Usual care: medication management only | |
| Outcomes | Assessment: baseline, 3 months 6MWT, CRQ, ICET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Within each physiotherapy practice, four out of eight patients were randomly allocated to group RC, and four patients to group CR (block randomisation procedure; four closed envelopes for condition RC and four closed envelopes for condition CR) Baseline assessments were carried out prior to randomisation" (pg 105) |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment "four closed envelopes for condition RC and four closed envelopes for condition CR" (pg 105) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention were aware of those allocated to the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessments: not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No information available |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT into 4 groups | |
| Participants | Setting: out-patient, Los Angeles Inclusion criteria:
Exclusion criteria:
Participant status: Age (years± SD): RG: 69 (10); CG: 68 (9) Gender (M/F):RG: 12/0; CG: 12/0 FEV1 % predicted: RG: 36% (9); CG: 39% (12) Participants randomly assigned: Randomised: 26 | |
| Interventions | Pulmonary rehabilitation: out-patient (hospital) LLE, nutritional instruction provided Usual care: Placebo injections and no training | |
| Outcomes | Assessment: baseline and 10 weeks Peak work rate | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Subjects were randomly assigned to treatment groups based on randomisation tables; randomisation was stratified for age < or ≥ 67 years and FEV1 < or ≥ 40% predicted" (supplement) |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (from study author) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, it was not possible to blind participants to their allocation of exercise or to blind those delivering the exercise |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Investigators and study coordinators were blinded as to whether subjects received testosterone or placebo" (supplement) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 53; completed: 47 (88.7%); attrition: 6 (11.3%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None identified |
| Methods | Study design: 2-Arm, cluster-randomised controlled trial | |
| Participants | Setting: community based, West of Ireland Inclusion criteria:
Exclusion criteria:
Participant status: Age (years± SD): RG: 68.8 ±10.2; CG: 68.4 ± 10.3 Gender (M/F): RG: 117/61; CG: 106/66 FEV1 % (pred ± SD): RG: 57.6 ±14.3 ; CG: 59.7 ±13.8 Participants randomly assigned: Randomised: 350 (16 clusters in control and 16 clusters in intervention) (participants: 178 intervention; 172 control) Analysed: Rehab: 178 | |
| Interventions | Pulmonary rehabilitation: community based, structured, nurse-led and delivered in the primary healthcare setting Aerobic exercise, ULE, LLE, Edu, phone support, respiratory muscle training Duration: 8 weeks, 2 hours per week Usual care: routine GP care | |
| Outcomes | Assessment: baseline and 12 weeks Incremental shuttle walking test, CRQ, Self-Efficacy for Managing Chronic Disease 6-item scale | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random allocation using computerised random sequence generation" (Casey 2013, pg 3) |
| Allocation concealment (selection bias) | Low risk | "Group allocation concealment was achieved by giving responsibility for computerised allocation sequence generation and group allocation to a researcher independent of the research team and blinded to baseline outcome data" (Casey 2013, pg 3) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research assistants trained in outcome assessment, blinded to group allocation" (Casey 2013, pg 3) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 350; completed: 277 (79%); attrition: 73 (21%) |
| Selective reporting (reporting bias) | Low risk | Outcomes reported matched the protocol |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT; randomisation into 3 groups | |
| Participants | Setting: 2 centres in Spain Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): PG: 68 (7); CG: 69 (5) Gender (M/F): all male FEV1 % (pred): RG: 47.8 (5); REG: 44.3 (11.9); CG: 38.7 (5) Participants randomly assigned: Randomised: 36 Combined resistance and endurance group: 14 Resistance alone group: 14 Control: 8 Did not include anyone who did not finish the intervention | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital-based PR); 3 groups: resistance training alone (n = 14); combined resistance and endurance training (n = 14); and control group (n = 8) Duration: 12 weeks. (twice a week 45-60 minutes) Usual care | |
| Outcomes | Assessment: baseline and 12 weeks CRQ, 6MWT | |
| Notes | Combined group of REG/RG used in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "For each subject included in the study, a researcher picked closed ticket with a number inside (from 1 to 3). The number corresponded to one of the three study groups" (additional information from study author) |
| Allocation concealment (selection bias) | Low risk | Allocation: closed ticket with a number inside (additional information from study author) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, it is not possible to blind participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes, according to the study authors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Did not include anyone who did not finish the intervention; unclear as to attrition |
| Selective reporting (reporting bias) | Low risk | Provided summary of all outcomes |
| Other bias | Low risk | |
| Methods | Study design: single-blind, randomised controlled trial Randomly assigned to 1 of 3 groups (TCQ group, exercise, control) | |
| Participants | Setting: 5 general outpatient clinics in Hong Kong Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 73.6±7.5; CG: 73.6 ±7.4 Gender (M/F): RG: 61/8; CG: 58/9 FEV1 % (pred ± SD ): RG: 91 ±.39; CG: 89 ±.39 Participants randomly assigned: Randomised: 206 (TCQ 70, exercise 69, control 67) | |
| Interventions | Pulmonary rehabilitation: community (primary care setting) ULE, LLE, respiratory muscle training (Tai chi Qigong + exercise) Duration: completed 60 minutes twice a week for 3 months Usual care: instructed to maintain usual activities | |
| Outcomes | Assessment: baseline and 3 months Spirometry results, 6MWD, SGRQ, multi-dimensional scale of perceived social support (MSPSS) Secondary outcomes Number of exacerbations, hospital admissions, Borg scale, SaO2 | |
| Notes | TCQ group not included in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random allocation was done using a randomizer software" (pg 5) |
| Allocation concealment (selection bias) | Unclear risk | Not informed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research assistants (RAs) for data collection were blind to the study in order to minimize researcher bias" (pg 6) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 206; completed: 158 (76.7%); attrition: 48 (23.3%) |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported between Chan 2010 and Chan 2011 articles and protocol paper |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT into 2 groups | |
| Participants | Setting: out-patient Inclusion criteria:
Exclusion criteria: Participant status: Age (years ± SD): RG: 63 ±11 ; CG: 65 ±13 Gender (M/F): RG: 12/1; CG: 5/1 FEV1 % (pred ± SD): RG: 43% ±21; CG: 51% ±17 Participants randomly assigned: Randomised: 19 | |
| Interventions | Pulmonary rehabilitation: outpatient hospital LLE, BE Usual care: conventional care | |
| Outcomes | Assessment: baseline and 8 weeks ICET, SGRQ, 6MWT | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomized using specific PC program taking into consideration severity of bronchial obstruction and aimed at desired ratio 2:1" (letter from study author) |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention had to be aware of those who were in the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No information provided in relation to attrition, and no indication in results that any participants did not complete the second assessment |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found at http://www.controlled-trials.com/mrct/ or www.who.int/trialsearch (searched for author names and parts of title of paper or intervention) |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT | |
| Participants | Setting: hospital in Glasgow recruited from a hospital chest clinic; recruited for home-based exercise Inclusion criteria:
Exclusion criteria: Participant status: Age (years± SD): RG: 58 ± 8 ; CG: 55 ± 8 Gender (M/F): N/A FEV1 ± SD : RG: 1.72 L ± 0.83; CG: 1.44 L ±0.59 Participants randomly assigned: Randomised: 48 | |
| Interventions | Pulmonary rehabilitation: home exercise LLE, ULE Usual care: Control group asked to continue with their usual daily routine | |
| Outcomes | Assessment: baseline and 12 weeks ICET, ITT | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information not available "The 48 patients were randomly allocated into training (n=32) or control (n=16) groups, with a 2:1 training versus control ratio" (pg 2591) |
| Allocation concealment (selection bias) | Unclear risk | Information not available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants undertaking the exercise had to be aware that they were receiving same |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned whether assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No account provided of any attrition after allocation; difficult to interpret from the graphs and tables how many completed |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT, randomly assigned to 1 of 4 interventions | |
| Participants | Setting: North Tyneside and South Northumberland from primary and secondary care Inclusion criteria:
Exclusion criteria:
Participant status: Age (years± SD ): 68.9 ± 7.3 across all groups Gender: male 113 (44.1%): combined 32, exercise 32, CBSM 31, cont 18 Female 143 (55.9%): combined 42, exercise 35, CBSM 33, cont 32 FEV1 % (pred± SD): 52.4% ± 15.7 across all groups Participants randomly assigned: Commenced: 256 Group 1: allocated combined: 74 Group 2: allocated exercise: 67 Group 3: allocated CBMS: 65 Group 4: allocated control: 50 | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital-based PR) Aerobic, ULE, LLE, cognitive behavioural self-management Duration: 6 weeks (twice weekly, sessions lasting 2 hours) Usual care: This group of participants received no intervention, except standard care | |
| Outcomes | Assessment: baseline and 6 weeks, 6, 12 months CRQ, Short Form-12 (SF-12), Psychological State Hospital Anxiety and Depression Scale, COPD Self-Efficacy Scale (COPD-SES) | |
| Notes | Incomplete results available for analysis of CRQ (reported as medians) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The random allocation sequence was generated using cards numbered one to four, which were picked at random. Randomisation was stratified according to site and cohort. There were different sequences for each site (Northumberland and North Tyneside) and a new sequence was started for each of the five cohorts" (pg 34) |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes: "Letters detailing the group the subject had been randomised to and details of the intervention were then placed in envelopes. Only the patient ID number was visible on the outside of the envelopes" (pg 34) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Study participants and the practitioners running the interventions could not be blinded to which intervention they were receiving" (pg 34) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "However, both the subjects and the researchers were blinded to the results of previous assessments (they were not allowed to see previous answers to questionnaires for example)" (pg 34) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 256; completed: 46 (57%); attrition: 43% |
| Selective reporting (reporting bias) | Low risk | Appeared to report what had been identified for reporting |
| Other bias | Low risk | None reported |
| Methods | Study design: RCT The first 20 were allocated entirely randomly, and the remaining 19 by a method known as "minimisation," which ensured an even spread of certain variables between groups Randomisation process: sealed envelopes Outcome assessments: blinded | |
| Participants | Setting: in-patient graduated exercise Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 61± 5; CG: 60 ± 5 Gender (M/F): RG: 18/0; CG: 16/0 FEV1 ± SD: RG: 1.53 L ±0.70; CG: 1.32 L ± 0.44 Participants randomly assigned: Randomised: 39 | |
| Interventions | Pulmonary rehabilitation: out-patient rehabilitation centre LLE, ULE Duration: 6 weeks | |
| Outcomes | Assessment: baseline and 2, 4 months 12-Minute WT, ITT | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: sealed envelopes (letter from study author) |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As participants had to undertake exercise, they were aware of the group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 39; 3completed: 4; attrition: 12% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | Gender selection: male only |
| Methods | Study design: RCT; participants were allocated to 3 experimental groups: control group (CG), floor group (FG) and aquatic group (AG) The randomisation process was conducted by a researcher who was not involved in data collection, through the use of opaque envelopes sealed and numbered consecutively in the ratio 1:1:1 and containing study group assignment | |
| Participants | Setting: Brazil Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: [FG: 56.9; AG: 62.4]; CG: 71.1 Gender (M/F): RG:[ FG: 8/5; AG: 4/4]; CG: 8/3 FEV1 % (pred± SD): RG:[ FG: 39.2 ± 11.4; AG: 43.9 ± 10.3]; CG: 45.1 ± 12.6 Participants randomly assigned: 32 participants were randomly assigned Analysed: Aquatic group (AG): 8 Control group (CG): 11 | |
| Interventions | Pulmonary rehabilitation: Low-intensity water and floor exercises on COPD Duration: 8 weeks (3 times: Each session lasted 1 hour and 30 minutes) Usual care | |
| Outcomes | Assessment: baseline and 8 weeks (6MWT), BODE Index, SGRQ | |
| Notes | Combined 2 intervention groups for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The randomisation process was conducted by a researcher not involved in data collection (contact with study authors) |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes (contact with study authors) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants because of the nature of the condition |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All evaluations (initial and final) were performed by a single investigator, who did not know to which group participants were allocated |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 42 participants randomly assigned; losses: 10 Attrition: 24% |
| Selective reporting (reporting bias) | Low risk | It was reported that all said they would |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT; randomly assigned to 3 groups: controls, PR and acupuncture and PR Randomisation occurred with the use of a random numbers table | |
| Participants | Setting: Dublin (identified via referral from the respiratory service) Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: [PR only 67.7 ± 5.3, PR + Acu 65.1 ±9.7]; CG: 68.6 ± 5.5 Gender (M/F): RG: [PR only 11/14, PR + Acu 8/8]; CG: 12/7 FEV1 % (pred ± SD): RG: [PR only 77.0 ±19 , PR + Acu 80.7 ± 24.2]; CG: 45.8 ± 1 8.3 Smokers, packs per year: RG: [PR only 51, PR + Acu 846.5]; CG: 46.2 Participants randomly assigned: 60 randomised (control 19, PR 25, 19 PR + Acu) Analysed: 14 control 11 PR | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital-based PR) Aerobic, ULE, LLE, respiratory muscle training, Edu Duration: 7 weeks, 14 PR sessions Usual care: no specific intervention | |
| Outcomes | Assessment: Baseline, end of PR and 3-month follow-up St. George’s Questionnaire Incremental shuttle walk test FEV1, Pi Max Feree Living Physical Activity, EQ5D | |
| Notes | Only the PR group was reported on in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation occurred with use of a random numbers table |
| Allocation concealment (selection bias) | Unclear risk | No information available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, it is not possible to blind participants or those delivering the programme |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors and the medical team analysing the blood samples were blinded to the treatments received |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 44 in control and PR groups; assessed: 25 Attrition: 19 (42%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Unclear risk | None identified |
| Methods | Study design: RCT; 2 groups Participants were randomly allocated to control or experimental groups with the use of number tables. Concealed until after allocation; once allocated, both participants and those delivering the intervention were aware of those in the intervention group | |
| Participants | Setting:
Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 59.67 ± 8.6; CG: 58.08 ± 11.45 Gender (M/F): RG: 33/6; CG: 33/6 FEV1 % (pred): RG: 47.7; CG: 46.28 FEV1/FVC (± SD): RG: 55.46 ± 8.79; CG: 55.10 ± 7.17 Smokers %: RG: 33.3; CG: 20.5 Participants randomly assigned: 78 participants with COPD randomised: Analysed: 39 experimental group 39 control group | |
| Interventions | Pulmonary rehabilitation: combined home/community/out-patient Duration: 3 months; exercises twice a day for 10 minutes, 5 days a week, at home under the supervision of a relative participants performed 24 sessions Aoribic, ULE, LLE, Edu Usual care: Control group received standard medical care | |
| Outcomes | Assessment: baseline,1 month, 3 months St. George’s Questionnaire SF-36, HADS Hospital Anxiety and Depression, 6MWT, MMRC | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly allocated to control or experimental groups with the use of number tables |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, participants had to be aware of their allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | However, the nurse was blinded to the results of the SF-36, SGRQ, HADS and MMRC |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No account of attrition provided |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | High risk | Gender imbalance noted |
| Methods | Study design: RCT (3 groups: exercise, education and stress management (EXESM); education and stress management (control) Randomisation process: random numbers table Outcome assessments: blinded | |
| Participants | Setting: out-patient Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 65 ± 6; CG: 67 ± 7 Gender (M/F): RG: 15:15; CG: 12/13 FEV1 (±SD): RG: 1.29 L ± 0.63; CG: 1.02 L ± 0.37 Participants randomly assigned: Randomised: 79 | |
| Interventions | Pulmonary rehabilitation: 3 groups: floor group (FG), aquatic group (AG) and control group (out-patient) LLE, ULE, Edu, Psy Usual care: asked not to alter activities significantly during the 10-week study | |
| Outcomes | Assessment: baseline and after the 10-week intervention period ICET, SIP | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | From a random number schedule, printed on a piece of paper |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Concealed until after allocation; once allocated, both participants and those delivering the intervention were aware of those in the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Technical staff conducting the assessments were not aware of group assignments |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall loss: 6 Attrition: 7.6% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: out-patients and home patients recruited from Pulmonary Medicine Department in Goteborg, Sweden Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 66 ± 5; CG: 67 ± 5 Gender (M/F): RG: 14/12; CG: 12/12 FEV1 % (pred): RG: 30.7; CG: 34.1 Smokers: RG: 6; CG: 4 Participants randomly assigned: Randomised: 55 | |
| Interventions | Pulmonary rehabilitation: out-patient and home based LLE, ULE, Edu, IMT Usual care: Control received usual out-patient care | |
| Outcomes | Assessment: baseline to 12 months 6-Minute WT, ICET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer random number tables |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Those receiving the programme had to be aware that they were receiving the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded for HRQoL, not blinded for WT |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 50 out of 55 completed (90.9%) Attrition rate: 9.1% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT (2 groups); 2 weeks after onset of oxygen therapy, 20 participants were randomly assigned to rehabilitation | |
| Participants | Setting: in-patient/home Department of Pulmonary Medicine of the Karolinska Hospital: over 2 years Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 72 ± 9; CG: 70 ± 8 Gender (M/F): RG: 3/7; CG: 3/7 FEV1 % (pred ± SD): RG: 26 ± 7 ; CG: 28 ± 6 Participants randomly assigned: Randomised: 20 (RG: 10; CG: 10) | |
| Interventions | Pulmonary rehabilitation: in-patient and home based Aerobic, ULE, LLE, Edu Duration: 8-Week programme with 1 training session a week; training took 90 to 120 minutes Usual care | |
| Outcomes | Assessment: baseline and 8 weeks, 6 months CRQ, 6-Minute WT, spirometry, blood gas analyses, pulse oximetry, Hospital Anxiety and Depression Scale (HADS) Stanford Health | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No clear statement on random sequence generation |
| Allocation concealment (selection bias) | Unclear risk | No detail re allocation concealment or how randomisation was done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the programme were aware of those included in the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced overall: 20; finished week 8: 14 Attrition: 30% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was registered, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: recruited from primary care; 16 GP practices in Exeter Inclusion criteria:
Exclusion criteria:
Participant status: Age: not provided Gender (M/F): not provided FEV1 % (pred): not provided Smokers: all current non-smokers Participants randomly assigned: Randomised: 20 (RG: 10; CG: 10) | |
| Interventions | Pulmonary rehabilitation: community (primary care setting) Exercise programme run in an exercise facility at a university Aerobic, ULE, LLE, Edu Duration: 8 weeks once-weekly 90-minute supervised exercise and education sessions delivered by a qualified exercise and healthcare practitioner Usual care: Control group received usual care. All were given tiotropium | |
| Outcomes | Assessment: baseline, 1 week post intervention CRQ, ISWT, lung information needs questionnaire (LINQ), HADS, 7-day physical activity recall questionnaire, physical self-perception profile (PSPP) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation sequence, stratified for smoking status, computer generated by a statistician who was independent of the trial |
| Allocation concealment (selection bias) | Low risk | Group allocation was kept concealed by means of sealed envelopes, which were opened in sequence by the trial researcher following baseline assessment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind participants or GPs to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors not blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 20 randomly assigned; attrition: overall 6 (30%) |
| Selective reporting (reporting bias) | Low risk | All outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) performed in a 300-bed district hospital and involving patients with very severe COPD who received oxygen treatment | |
| Participants | Setting: Spanish study; 300-bed district hospital Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 66 ± 8; CG: 70 ± 5 Gender (M/F): 1 woman, as the rest were men FEV1 % (pred ± SD): RG: 33 ± 10; CG: 38 ± 12 FEV1/FVC (± SD): RG: 42 ± 10; CG: 42 ± 11 Participants randomly assigned: Randomised: 50 (RG: 30; CG: 20) | |
| Interventions | Pulmonary rehabilitation: home based Aerobic exercise, ULE, LLE, educational material, home physio visits Duration: received 2 one-hour sessions in the hospital. A minimum of 1 hour of exercise per day was indicated, for a minimum of 5 days per week Usual care | |
| Outcomes | Assessment: baseline and Imediately post intervention (1 year) 6MWT, SGRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not informed of process: only "randomly divided into 2 groups" |
| Allocation concealment (selection bias) | Unclear risk | Not informed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants or those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not informed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | After 1 year, 41 participants completed (83.7%) Attrition: 16.3% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | High risk | All men; 1 woman excluded from analysis |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: recruited from an out-patient clinical at the Chester Hospital NHS Trust, UK Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± Sd ): RG: 70.4 ± 8.0; CG: 68.4 ± 10.4 Gender (M/F): RG: 25/11; CG: 19/10 FEV1 % (pred ± SD): RG: 41.2 ± 19.2; CG: 41.2 ± 16.2 Smoking NO: RG: 2; CG: 6 Participants randomly assigned: Randomised: 100 (27 did not attend initial assessment) | |
| Interventions | Pulmonary rehabilitation: 6-Week out-patient-based rehabilitation programme ULE, LLE, Edu Usual care: Control group reviewed routinely as medical out-patients | |
| Outcomes | Assessment: baseline, 12 weeks and 24 weeks 6-Minute WT, SGRQ | |
| Notes | Jadad's score = 3 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was in blocks of 10, using random numbers |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the exercise programme, unable to blind allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Both tests were supervised by a blinded observer who subsequently repeated these assessments" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 100 randomly assigned; 55 completed (55%) Only 73 attended for initial assessment 45% attrition |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: out-patient community, training in sports hall; Germany Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 62.5 ± 7; CG: 63.2 ± 8.5 Gender (M/F): RG: 6/4; CG: 7/2 FEV1 % (pred ± SD): RG: 53.4 ± 10.7; CG: 53.7 ± 5.8 Participants randomly assigned: Randomised: 34 (RG: 17; CG 17) | |
| Interventions | Pulmonary rehabilitation: community, complex long-term training programme Aerobic exercise, ULE, LLE (escalating levels of activity over time) Duration: 12-month training programme Usual care: Control group did not receive therapy | |
| Outcomes | Assessment: Baseline and 12 months (end of intervention) 6MWT, St. George’s Questionnaire, SF-36, muscle force | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Assigned to training group or control group at random (chosen by lot) |
| Allocation concealment (selection bias) | Unclear risk | Not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, it is not possible to blind participants or those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 34; completed: 19; lost: 15 Attrition: 44% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) Randomisation process: random numbers table Outcome assessments: blinded | |
| Participants | Setting: in-patient/out-patient; Canada Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 66 ± 7; CG: 65 ± 8 Gender (M/F): RG: 21/17; CG: 17/23 FEV1 % (pred ± SD): RG: 34.8 ±14.5; CG: 34.6 ± 11.8 FEV1 /FVC: RG: 36.8 ± 9.5; CG: 38.8 ± 12.4 Smoking packs (± SD): RG: 58 ± 24; CG: 51 ± 26 per year Participants randomly assigned: Randomised: 89 | |
| Interventions | Pulmonary rehabilitation: in-patient/home based Aerobics, LLE, ULE, BE, Edu, Psy Usual care: Control group received conventional care from general practitioner and respiratory specialist | |
| Outcomes | Assessment: baseline and 24 weeks 6-Minute WT, ICET, SSCET, CRQ, BDI/TDI | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random tables for allocation |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention were aware of the allocation of participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigator carrying out outcome assessments blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 89 randomised and 78 completed Attrition: 11 (12%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups); PR for 3 months and rehabilitation maintenance for 12 months (RHBM group). Second group received PR for 3 months only (RHB group) and the third was the control | |
| Participants | Setting: recruited by family physicians from 7 primary care practices in Palma de Mallorca, Spain Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG (RHB: 64.1; RHBM: 64.9); CG: 63.4 Gender (M/F): RG: 39/9; CG: 19/4 FEV1 % (pred): RG: 74 (Range 66.5-81.5); CG: 60.1 (Range 55.6-64.4) FEV1/FVC: RG: 61.2; CG: 59.1 Participants randomly assigned: Randomised: 97 (33 RHB group and 32 RHBM; control 32) | |
| Interventions | Pulmonary rehabilitation: community (primary care setting) Aerobic exercise, ULE, LLE, educational material Duration: 3 months; rehabilitation maintenance for 12 months Usual care: Group received routine care without rehabilitation | |
| Outcomes | Assessment: Baseline, 3 months and 12 months CRQ, pulmonary function tests, 6MWT | |
| Notes | Analyses completed on 3-month results for combined RHB and RHBM groups | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Centrally administered, computer-generated block randomisation scheme using blocks of 6 with EPIDAT, stratified according to participating site |
| Allocation concealment (selection bias) | Low risk | See above |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Health staff members involved in follow-up (a psychologist and a nurse) were blinded to participant assignment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Out of 97, only 50 at 3-month evaluation Attrition: 47 (48%) |
| Selective reporting (reporting bias) | Low risk | Trial registration (ISRCTN94514482); all outcomes stated in the study appear to have been measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: out-patient: referred from an outpatient department in Leuven, Belgium Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 60 ± 9; CG: 63 ± 7 Gender (M/F): RG: 31/6; CG: 30/3 FEV1 % (pred ± SD): 41 ±16; RG: CG: 43 ±12 Participants randomly assigned: Randomised: 100 | |
| Interventions | Pulmonary rehabilitation: outpatient sessions; cycling, treadmill walking, stair climbing and peripheral muscle training LLE, ULE Duration: 24 weeks: 3 times a week in the first 3 months; during subsequent 3 months, training frequency was reduced to twice weekly. Each session had a duration of 1.5 hours Usual care: usual medical care | |
| Outcomes | Assessment: baseline and at 6 months and 18 months 6-Minute WT, ICET, CRQ Isometric quadriceps strength, inspiratory and expiratory muscle strength | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: sealed envelopes |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention were aware of the allocation of participants |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessments: not blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 100; 6 months: 62; remaining: 62% Attrition: 38% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) Single-centre, randomised, placebo-controlled, unblinded clinical trial | |
| Participants | Setting: patients listed with 56 GPs in Copenhagen, Denmark Inclusion criteria:
Exclusion criteria:
Participant status: Age (years, Range): RG: 74.1 (66–82); CG: 73.2 (67–88) Gender (M/F): RG: 7/15; CG: 7/13 FEV1 % (pred ± SD): RG: 64.27 ± 7.9; CG: 67.05 ± 8.8 FEV1 /FVC (± SD): RG: 0.54 ± 0.07; CG: 0.6 ± 0.1 Smokers: RG: 11; CG: 9 Participants randomly assigned: Randomised: 61 (RG: 35; GG: 26) | |
| Interventions | Pulmonary rehabilitation: community Aerobic exercise, ULE, LLE, Edu, follow-up call Duration: 7 weeks; two 90-minute sessions a week Usual care: standard COPD care received from GP | |
| Outcomes | Assessment: baseline and 6 months 6MWT, MRC, SGRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed using sealed opaque envelopes randomly assigned to participants |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participants and those delivering the intervention were aware of the allocation of participants |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded clinical trial |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 61 randomly assigned, 42 completed (68%) Attrition: 32% |
| Selective reporting (reporting bias) | Low risk | Study authors appear to have reported what they said they would at the beginning of the article |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: recruited from local hospitals and local general practices to participate; Wales Out-patient + Home-based follow-up Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 68.2 ± 8.2; CG: 68.3 ± 8.1 Gender (M/F): RG: 57/36; CG: 54/37 FEV1 % (pred ± SD): RG: 39.7 ±16.2; CG: 39.4 ±16.4 FEV1 /FVC (± SD): RG: 0.49 ± 0.13; CG: 0.49 ± 0.13 Smoking, packs per year: RG: 43.5 (31.1); CG: 45.7 (21.9) Participants randomly assigned: Randomised: 200 | |
| Interventions | Pulmonary rehabilitation: multi-disciplinary, out-patient/home based LLE, ULE, Edu, Psy, NS, SmC Usual care: continued with usual out-patient or primary care follow-up | |
| Outcomes | Assessment: baseline and follow-up for 1 year Shuttle WT, CRQ, SF-36, SGRQ, HADS | |
| Notes | Jadad's score = 2 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: sealed envelopes |
| Allocation concealment (selection bias) | Low risk | Study investigators unaware as to order of treatment group assignment (Cochrane Grade A) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, it is not possible to blind participants or those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 200 commenced; 180 completed Attrition: 10% |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups) | |
| Participants | Setting: patients from Ege University Hospital Turkey outpatient clinic admitted to the PR unit between January 2010 and November 2010 Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: [PRNS: 64.0 ± 10.8; PR: 66.8 ± 9.6]; CG: 67.8 ± 6.6 Gender (M/F): RG: [PRNS 13/2; PR: 15/0]; CG: 16/0 FEV1 % (pred ± SD): RG:[ PRNS: 41.9 ± 10.8; PR: 41.9 ± 13.2]; CG: 39.3 ± 9.3 FEV1 /FVC (± SD): RG: [PRNS: 53.4 ± 15.8; PR: 49.0 ± 6.7]; CG: 46.7 ± 7.2 Participants randomly assigned: Randomised: 46 | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital based). Pulmonary rehabilitation and nutritional support (Pr Alone (PR) or PR and nutritional support (PRNS)) Aerobic exercise, ULE, LLE, educational material, nutritional support Duration: 8 weeks Usual care: usual medical standard care | |
| Outcomes | Assessment: baseline and following 8 weeks of PR MRC, 6MWT, ISWT, ESWT, SGRQ, HADS | |
| Notes | Reported results using combined group PR + PRNS | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Eligible patients were randomly assigned in a 1:1:1 ratio with the use of sealed envelopes |
| Allocation concealment (selection bias) | Low risk | As above |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants or those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition reported |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | High risk | All men; 15 in PR group, 15 in control. 2 women in PRNS |
| Methods | Study design: RCT (2 groups) Randomisation process: random numbers table Outcome assessments: blinded | |
| Participants | Setting: out-patient: secondary care respiratory clinic in Barcelona Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: 66 (7); CG: 65 (6) Gender (M/F): all men FEV1 % (pred): RG: 31 (12); CG: 39 (14) Participants randomly assigned: Randomised: 60 | |
| Interventions | Pulmonary rehabilitation (out-patient and home based; 3 months of outpatient breathing retraining and chest physiotherapy; 3 months of daily supervised exercise) LLE, BE, PD Usual care: Control group received standard care | |
| Outcomes | Assessment: baseline and 3, 6, 9, 12, 18 and 24 months 6MWT, ICET, CRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random number tables; letter sent to LaCasse |
| Allocation concealment (selection bias) | High risk | No concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind both participants and those delivering the intervention because of the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Technicians who collected data for outcome measures at every visit, as explained below, were blinded to participants' allocation to PR or control groups |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All 60 participants completed 6 months of follow-up |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | High risk | All men only |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: out-patient Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): 68 ± 8; CG: 66 ± 8 Gender (M/F): RG: 16/2; CG: 17/0 FEV1 % (pred ± SD): RG: 32% ±11; CG: 38% ±15 Participants randomly assigned: Randomised: 40 | |
| Interventions | Pulmonary rehabilitation: 2 months of chest physio and 2 months of muscle training LLE, IMT Usual care | |
| Outcomes | Assessment: baseline and post intervention (8 weeks) CRQ, 6MWT, dyspnoea, maximal workload | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers table |
| Allocation concealment (selection bias) | High risk | Randomisation was not concealed, but the likelihood of bias introduced by unconcealed randomisation was reduced by recruitment of consecutive patients |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind both participants and those delivering the intervention because of the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Technicians who collected data were blinded to participant allocation to the PRG or the CG, as were data analysts, until the analysis was deemed complete |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 40; attrition: 5 (12%) |
| Selective reporting (reporting bias) | Low risk | No protocol paper was found, but all outcomes listed in the paper appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) Randomisation process: random numbers table Outcome assessments: blinded | |
| Participants | Setting: home-based; Seville, Spain Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 64.3 ± 8.3 ; CG: 63.1 ± 6.9 Gender (M/F): RG: 20/0; CG: 17/0 FEV1 % (pred ± SD): RG: 71.1 ± 18.9; CG: 74.7 ± 14.7 FEV1 /FVC (SD): RG: 47 ± 9.9; CG: 42.3 ±12 Participants randomly assigned: Randomised: 60 | |
| Interventions | Pulmonary rehabilitation: home rehabilitation programme; training intensity was determined individually LLE Usual care: Control group participants (standard medical treatment alone; also made visits to the hospital every 2 weeks for a clinical checkup and for supervision of treatment) | |
| Outcomes | Assessment: baseline and 12 weeks ICET, Shuttle WT, CRQ, BDI/TDI | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers table used |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind both participants and those delivering the intervention because of the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators were blinded (letter from study author) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 60 randomly assigned; 37 completed (61.6%) Attrition: 38.3% |
| Selective reporting (reporting bias) | Low risk | It appears that all outcomes stated at the outset of the article were reported in the findings |
| Other bias | Low risk | Participants who were excluded because they did not meet the criteria appear to have been excluded after randomisation |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: Norway Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 62.8 ± 1.4; CG: 60.6 ± 3.0 Gender (M/F): RG: 4/2; CG: 4/2 FEV1/FVC (± SD): RG: 49.9 ± 4.6; CG: 45.2 ± 6.0 Participants randomly assigned: Randomised: | |
| Interventions | Pulmonary rehabilitation: lab-based maximal strength training (seated horizontal leg press apparatus) LLE Duration: 8 weeks Usual care: Control group continued normal daily living with modest regular activity, as recommended by pulmonary physician | |
| Outcomes | Assessment: baseline and week 8 Incremental cycle ergometry | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information provided |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind both participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study protocol with no adverse effects, and the MST group completed 100% of the planned training |
| Selective reporting (reporting bias) | Low risk | No protocol was identified. All outcomes identified in the methods section of the paper were reported in the results |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups: exercise, resistive breathing, control) | |
| Participants | Setting: home based; recruited from a chest clinic in Dunedin, New Zealand Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 63.8 ± 6.09; CG: 62.7 ± 8.36 Gender (M/F): RG: 6/2; CG: 1/5 FEV1 % (pred ± SD): RG: 0.78 ± 0.27; CG: 0.68 ± 0.12 Smoking: RG: 8; CG: 5 Participants randomly assigned: Randomised: 30 (exercise 11, breathing 11, control 8) Control: 6 | |
| Interventions | Pulmonary rehabilitation: Simple physical exercises at home under the supervision of a physiotherapist and every 2 weeks in the gymnasium LLE, ULE Usual care: placebo respiratory device and usual care | |
| Outcomes | Assessment: baseline and 10 weeks 12-Minute WT, ICET, SSCET, daily diary, Lubin Affectometer | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: drawing lots |
| Allocation concealment (selection bias) | High risk | No concealment apparent |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind both participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: not blinded for ICET, blinded for the others |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Commenced: 19; completed: 14 (73.7%) Attrition: 26.3% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified. All outcomes identified in the methods section of the paper are reported in the results |
| Other bias | High risk | Control received a placebo respiratory device, which may have an impact |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: Dept Chest Medicinein Izmir, Turkey Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 64.81 ± 9.4; CG: 67.21 ± 6.72 Gender (M/F): RG: 21/5; CG: 18/1 FEV1 %: RG: 55.50%; CG: 58% Participants randomly assigned: Randomised: 54 | |
| Interventions | Pulmonary rehabilitation: out-patient programme Aerobic exercise, ULE, LLE, breathing exercises, educational material Duration: 8 weeks Education component: 16 sessions of discussion (1 hour/wk) Exercise component: 3 times a week Usual care | |
| Outcomes | Assessment: baseline, week 8 and week 12 6MWT, SGRQ | |
| Notes | Week 8 data used for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly assigned in a 1:1 ratio with the use of sealed envelopes |
| Allocation concealment (selection bias) | Low risk | |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind both participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not informed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 49; completed: 45 Attrition: 18.17% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified. All outcomes identified in the methods section of the paper are reported in the results |
| Other bias | Low risk | Participants who were excluded because they did not meet the criteria appear to have been excluded after randomisation |
| Methods | Study design: RCT (4 groups); participants were randomly assigned to a control group and to 3 actively trained groups | |
| Participants | Setting: intervention delivered in outpatient hospital setting; Perth, Western Australia Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 66.3 ± 6.8; CG: 65.7 ± 3.5 Gender (M/F): RG: 6/1; CG: 4/3 FEV1 % (pred ± Sd): RG: 0.97 ± 0.29; CG: 0.83 ± 0.25 Participants randomly assigned: Randomised: 28 | |
| Interventions | Pulmonary rehabilitation: out-patient hospital based: 4 groups (combined exercise: 7; upper limb: 6; lower limb: 7; control) LLE or ULE or both Usual care | |
| Outcomes | Assessment: baseline and immediately after the 8 weeks 6MWT, ICET, IAET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: randomisation chart |
| Allocation concealment (selection bias) | Unclear risk | No allocation concealment discussed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded for ICET, not blinded for 6MWT |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 28; finished: 26 (92.9%) Attrition: 7.1% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified. All outcomes identified in the methods section of the paper were reported in the results |
| Other bias | Unclear risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: Lek Yuen Family Medicine Teaching Clinic, Hong Kong, and the Family Medicine Training Centre of the Prince of Wales Hospital Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 69.5 ± 9.3; CG: 69.8 ± 10.3 Gender (M/F): RG: 20/5; CG: 18/7 FEV1 % (pred ± SD): RG: 0.9 ± 0.3; CG: 0.8 ± 0.4 Current smoker: RG 3 (12%); CG: 7 (28) Participants randomly assigned: Randomised: 50 (25 each group) | |
| Interventions | Pulmonary rehabilitation: community (primary care setting) Aerobic exercise, ULE, LLE, educational material, home physio visits Duration: 6 weekly sessions of psychoeducation, each lasting for 2 hours Usual care: given tiotropium, which is considered standard usual care | |
| Outcomes | Assessment: baseline, start of PRP, end of PRP and 3 months 6MWD, spirometry, CRQ | |
| Notes | For analysis, used mean and standard deviation of all other studies, as did not provide SD | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not provided |
| Allocation concealment (selection bias) | Unclear risk | Not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those delivering the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 50 randomly assigned; drop-out: 9 Attrition: 18% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified. All outcomes identified in the methods section of the paper were reported in the results |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups) Single-blind | |
| Participants | Setting: conducted in Hong Kong, in the care of respiratory specialists of Jiangs Province Hospitals from October 2008 to October 2010 Inclusion criteria: COPD severity level at GOLD stages I and II Exclusion criteria: no serious co-morbidities (e.g. pulmonary tuberculosis, emphysema, congestive heart failure) Participant status: Age (years± SD):RG:[ HQG: 61.82 ± 7.69; PRG: 61.34 ± 8.3]; CG: 62.2 ± 6.34 Gender (M/F): RG:[HQG: 78%/22%; RG: 72%/28%]; CG: 80%/20% FEV1 % (pred ± SD ): [HQG: 74.43 ± 12.93; PRP: 75.31 ± 12.84;] FEV1 /FVC (± SD): RG[HQG: 60.73 ± 6.18; PRP: 61.27± 5.86]; control: 61.43 ± 6.17 Never smoked: HQG: 37.3%; PRP: 43.8%; control: 34.3% Participants randomly assigned: Analysed: Control: 35 | |
| Interventions | Pulmonary rehabilitation: combined in-patient and/or home/community/out-patient Duration: 6 months; then encouraged to participate in peer-led weekly walking and ball game activities thrice a week, 1 hour each time, for 6 months Usual care: received health education and was advised to continue exercising alone | |
| Outcomes | Assessment: baseline and 6 months 6MWD, Zhongshan COPD Questionnaire for QoL, immune cell factor, hospital admissions | |
| Notes | Used only exercise group for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participant allocation list was drawn on the basis of random order of the block ("H-H-H-P-P-C-C") for 20 times, until a list of 140 individuals in a specific order was obtained |
| Allocation concealment (selection bias) | Low risk | Not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, participants and those delivering the programme could be randomly assigned |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcome assessors were blinded to each participant’s allocated group, as well as to the objectives of the study, to minimise bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomised: 132 (control: 36; PR: 36; Qigong: 60) 118 included in the final analysis (control: 35; PR: 32; Qigong: 51) So lost 14 overall (89%) participated; attrition: 11% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but all results re stated outcomes seem to have been included |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: home based; New Delhi, India Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 61.4 ± 5.6, CG: 57.2 ± 7.9 Gender (M/F): RG: 12/0; CG: 12/0 FEV1 % (pred ± SD ): RG: 0.97 L ± 0.33; CG: 1.15 L ± 0.72 FEV1 /FVC: RG:CG Participants randomly assigned: Randomised: 28 | |
| Interventions | Pulmonary rehabilitation: home-based training programme consisting of graded stair-climbing exercises tailored to suit the ability of the individual LLE Usual care: Control group did not receive exercise instructions or an out-patient check at 2 weeks | |
| Outcomes | Assessment: baseline and mean 14 weeks control; mean 19 weeks intervention 12-Minute WT, ICET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Used random numbers tables |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, participants and those delivering the programme could be randomly assigned |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessments: not blinded (letter from study authors) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 28 started; 24 finished (85.7%) Attrition: 14.28% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but all stated results re outcomes seem to have been included |
| Other bias | Low risk | None identified |
| Methods | Study design: RCT (3 groups, land based, water based, control) | |
| Participants | Setting: patients referred to outpatient pulmonary rehabilitation at an Australian tertiary public hospital Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG:[ water: 72 ± 10; land: 73 ± 7]; CG: 70 ± 9 Gender (M/F): RG: 15/23; CG: 7/8 FEV1 % (pred ± SD): RG: [WB: 60 ± 10; LB: 62 ± 15]; CG: 55 ± 20 FEV1 /FVC: RG: [WB: 59 ± 9; LB: 58 ± 9]; CG: 53 ± 13 Current smokers: RG: [WB: 3; LB: 1]; CG: 2 Participants randomly assigned: Randomised: 53 (control: 15; land based: 20; water based: 18) | |
| Interventions | Pulmonary rehabilitation: out-patient programme: hospital gymnasium; participants walked at an intensity of 80% of the average 6MWT speed over ground or on a treadmill. Water-based exercise training group exercised in a hospital hydrotherapy pool Aerobic exercise, ULE, LLE Duration: 8 weeks; three 60-minute sessions a week of supervised exercise led by the same experienced physiotherapist Usual care: Control group participants received usual medical care and no exercise training. They were asked not to alter their exercise level over the study period | |
| Outcomes | Assessment: baseline and 8 weeks CRDQ, 6MWT, ISWT, ESWT | |
| Notes | Please note: Combined intervention groups of land and water used for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned by an investigator external to the study using a Web-based computer-generated sequence |
| Allocation concealment (selection bias) | Low risk | Concealed allocation achieved with the use of opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the exercise interventions, it was not possible to blind therapists or participants to allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 53; analysed: 55 Attrition: 8 (15%) |
| Selective reporting (reporting bias) | Low risk | Registered on www.anzctr.org.au (ACTRN0126000408583) Primary outcomes and all planned secondary outcomes appear to have been reported |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: Iran Inclusion criteria:
Exclusion criteria: Participant status: Age (years ± SD): RG: 52.1 ± 10.7; CG: 52.17 ± 11.6 Gender (M/F): RG: 11/9; CG: 7/11 FEV1 % (pred): RG:CG: not available FEV1 /FVC: RG:CG: not available Participants randomly assigned: Randomised: 38 (RG: 20, CG: 18) | |
| Interventions | Pulmonary rehabilitation: outpatient clinic, exercised on a treadmill Aerobic exercise, ULE, LLE Duration: 4 weeks, 2 times a week Usual care: Control group completed no treadmill exercise training | |
| Outcomes | Assessment: baseline and 4 weeks VO2 peak, based on the Rockport formula | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the exercise interventions, it was not possible to blind therapists or participants to allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition reported |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but all stated results re outcomes appear to have been included |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups); outpatient group that performed all activities at the clinic, home-based group that performed activities at home and control group | |
| Participants | Setting: private pulmonology clinic in Cascavel (southern Brazil) Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: [home: 66.4; outpatients: 71.3]; CG: 70.8 Gender (M/F): RG:[ home: 27/6; outpatients: 19/4]: CG: 19/10 FEV1 % (pred): RG:[ home 47.5 ; outpatient 51.5 ]; CG: 41.4 Participants randomly assigned: Randomised: 117 | |
| Interventions | Pulmonary rehabilitation: outpatient clinic or home based Aerobic exercise, ULE, LLE, education Duration: 12 weeks, 3 times a week Usual care: Control group performed no PR | |
| Outcomes | Assessment: baseline and 12 weeks MRC, BODE Index, 6MWT | |
| Notes | Combined 2 intervention groups for the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned electronically by a computer to 3 groups |
| Allocation concealment (selection bias) | Low risk | Not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those delivering intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | 2 duly trained healthcare professionals were responsible for the evaluations, which were performed by the same evaluators for all participants |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Loss: 32; attrition: 27% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but all stated results re outcomes appear to have been included |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: nursing home residents in Turkey Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: 73.5; CG: 68 Gender (M/F): RG: 11/3; CG: 13/2 FEV1/FVC (Range): RG: 58.5 (48-65); CG: 57 (44-66) Participants randomly assigned: Randomised: 29 (RG: 14, CG: 15) | |
| Interventions | Pulmonary rehabilitation: Aerobic exercise, ULE, LLE, educational material Duration: 6 months, 3 days a week for 1.5 hours Usual care | |
| Outcomes | Assessment: baseline, 3 months and 6 months 6MWT, lower extremity strength test | |
| Notes | Note: Only medians and ranges provided, so cannot be used in analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not provided |
| Allocation concealment (selection bias) | Unclear risk | Not provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, unable to blind participants and those providing intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 29 people were randomly assigned 21 completed; loss of 8 people Attrition: 28% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but seems to have included all results re outcomes stated |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups); single- blind randomised trial | |
| Participants | Setting: 4 sites including 3 regional health services and 1 large metropolitan hospital; Australia Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 66.9 ± 7: CG: 68.4 ± 9.9 Gender (M/F): RG:CG FEV1 % (pred): RG: 49; CG: 52 FEV1/FVC: RG: 50; CG: 49 Hx smoking per day: RG: 40; CG: 26.5 Participants randomly assigned: Randomised: 54 (27 to each group) | |
| Interventions | Pulmonary rehabilitation: outpatient clinic and home based: under the supervision of an experienced physiotherapist; progressive resistance exercise programme ULE, LLE Duration: 12 weeks: 1 session per week facilitated, 2 sessions performed independently at home Usual care: Control group received no intervention | |
| Outcomes | Assessment: baseline and 3 months and 6 months CRDQ, 6MWT, Timed Up and Go Test, Grocery Shelving Test, Patient-Specific Functional Scale, participation restrictions: London Handicap Scale, hand-held dynamometry | |
| Notes | Utilised data at 3 months for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Generated by member of the research team not involved in participant recruitment |
| Allocation concealment (selection bias) | Low risk | Concealed allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and those delivering the intervention were aware of which individuals were included in the intervention group |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 54; loss: 44 Attrition: 19% |
| Selective reporting (reporting bias) | Low risk | No protocol was identified, but all results re stated outcomes appear to have been included |
| Other bias | High risk | All male |
| Methods | Study design: RCT (2 groups): water based exercise (WE) and control | |
| Participants | Setting: Chest Diseases Outpatient Clinic between April 2006 and November 2006; Turkey Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 60.9 ± 8.8; CG: 64.1 ± 8.9 Gender (M/F): all male FEV1 % (pred ± SD): RG: 54.5 ± 15.6; CG: 54.1 ± 20.2 FEV1/FVC (± SD) : RG: 56.0 ± 10.5; CG: 54.6 ± 9.1 Smoker: RG: 5 (20%); CG: 6 (24%) Participants randomly assigned: Randomised: 50 (25 in each) | |
| Interventions | Pulmonary rehabilitation: out-patient; water-based exercise (WE) Aerobic exercise, ULE, LLE Duration: 4-Week water-based pulmonary rehabilitation for 35 minutes 3 times a week Usual care: received only medical therapy | |
| Outcomes | Assessment: baseline and 1 month Spirometry, 6MWT, CRDQ, HAD Scale, arterial blood gas examination | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | According to "tables of random numbers" |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition reported |
| Selective reporting (reporting bias) | High risk | No protocol was identified, but results for CRQ of rehabilitation group were not provided |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: recruited from the pulmonary clinic at the University Hospital of Caracas Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 67 ± 5; CG: 62 ± 7 Gender (M/F): RG: 6/4; CG: 12/2 FEV1 % (pred ± SD): RG: 34 ± 11; CG: 30 ± 9 FEV1/FVC (± SD): RG: 39 ± 7; CG: 30 ± 9 Participants randomly assigned: Randomised: 24 (PG: 10; CG: 14) | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital-based PR) Aerobic exercise, ULE, LLE Duration: 8-Week programme 3 days per week in groups of 2 or 3 Usual care: Control group received optimal care, as suggested by the American Thoracic Society | |
| Outcomes | Assessment: baseline and Immediately after PR (8 weeks) Spirometry, Beck Depression Inventory, State Trait Anxiety Inventory, MRC Scale, SGRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not informed |
| Allocation concealment (selection bias) | Unclear risk | Not informed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not informed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Commenced: 24 (control: 14; intervention: 10) No loss reported |
| Selective reporting (reporting bias) | High risk | No protocol was identified, but results for the rehabilitation group for CR were not provided |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups): randomised tailored videotape, standard videotape, control | |
| Participants | Setting: physician referrals from private offices, the Denver office of Kaiser Permanente and the Denver Veterans Affairs Medical Center Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: [customised video: 68.8 ± 9.2; standard video: 68.4 ± 9.0]; CG: 66.8 ± 9.9 Gender (M): RG:[customised video: 39 (54.2%); standard video: 41 (59.4%)]; CG: 40 (54.8%) Current smoker: RG:[ customised video: 10 ± 14.3%); standard video: 18 ± 26.5%]; CG: 22 ±30.1% Participants randomly assigned: Randomised: 214 (customised video: 72; standard video: 69; control: 73) Analysed: | |
| Interventions | Pulmonary rehabilitation: home-based programme (in home): a tailored videotape (Group A) and a standard videotape (Group B) Aerobic exercise, ULE, LLE, educational material, home physio visits Duration: 8 weeks Usual care | |
| Outcomes | Assessment: baseline and 8 weeks Fatigue Impact Scale (FIS), Seattle Obstructive Lung Questionnaire (SOLQ), SF-36, 6MWD | |
| Notes | Data could not be analysed, as full results were not available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned to 1 of 3 groups in a blocked fashion to achieve balance |
| Allocation concealment (selection bias) | Unclear risk | Not known |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self-completion by participants |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned: 214; completed: 174 Attrition: 40 (19%) |
| Selective reporting (reporting bias) | High risk | No protocol was identified Results of the 6-minute walk test and SF-36 not presented |
| Other bias | Unclear risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: out-patient; Connecticut Inclusion criteria:
Exclusion criteria:
Participant status: Age (yearsn): RG: 66.3; CG: 66.1 Gender (M/F): RG: 5/5; CG: 5/5 FEV1 % (pred ± SD): RG: 35% ± 10; CG: 33% ± 15 Participants randomly assigned: Randomised: 20 | |
| Interventions | Pulmonary rehabilitation: outpatient LLE, ULE, BE, Edu, Psy Usual care: session with the OPR nurse clinician for optimisation of pulmonary therapy | |
| Outcomes | Assessment: baseline and 6 weeks ITT, BDI/TDI, 12MWD | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: random numbers table |
| Allocation concealment (selection bias) | Unclear risk | Not informed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant loss after allocation |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found at www.controlled-trials.com/mrct/ or www.who.int/trialsearch (searched for author names and parts of title of paper or intervention). However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) Randomisation process: sealed envelopes Outcome assessments: blinded | |
| Participants | Setting: delivered as an outpatient programme in Denmark Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 61.8 ± 6.8; CG: 64.6 ± 7.7 Gender (M/F): RG: 1/23; CG: 6/15 FEV1 % (pred ± SD): RG: 49.5 ± 17.4; CG: 44.3 ± 3.7 Current smoking: RG: 16; CG: 7 Participants randomly assigned: (130 approached; 45 randomised) | |
| Interventions | Pulmonary rehabilitation: out-patient (hospital) Aerobic, LLE, ULE, education, nutritional support Usual care: conventional community care | |
| Outcomes | Assessment: baseline and 8 weeks 6-Minute WT, SGRQ, Psychological General Well-being (PGWB), Borg Scale | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: sealed envelopes |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall commenced: 45; finished: 36 (84.4%) Overall attrition: 7 (15.6%) |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found at www.controlled-trials.com/mrct/ or www.who.int/trialsearch (searched for author names and parts of title of paper or intervention). However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups), stratified | |
| Participants | Setting: out-patient Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 73 ± 4.8; CG: 70 ± 5.7 Gender (M/F): RG: 5/9; CG: 10/4 FEV1 % (pred ± SD): RG: 39.5 ±18.96; CG: 39.2 ± 21.39 FEV1/FVC: RG: 49.4 (12.95); CG: 47.8 (14.04) Participants randomly assigned: Randomised: 34 | |
| Interventions | Pulmonary rehabilitation: Weight-lifting programme training was prescribed for upper and lower limb muscles; resistance was increased progressively LLE, ULE Usual care: Control group attended only for testing | |
| Outcomes | Assessment: baseline and 8 weeks 6MWT, ICET, SSCET, CRQ | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: coin toss |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded for CRQ, not blinded for the others |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 28/34 completed = 82.3% Attrition: 17.64% |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: home based, carried out by Department of Medicine, SMS Medical College and Hospital, Jaipur, India Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): 59.3 ± 6.4 Gender (M/F): male 32 (80%), female 8 (20%) FEV1 % (pred ± SD ): RG: 28 ± 7.5; CG: 26 ± 7.1 FEV1/FVC (±SD): RG: 44 ± 16; CG: 48 ± 10.4 Participants randomly assigned: | |
| Interventions | Pulmonary rehabilitation: domiciliary pulmonary rehabilitation for 4 weeks; supervised weekly to ensure that participants were following the rehabilitation schedule properly and were taking regular treatment LLE, IMT Usual care: Control group participants were asked to continue their activities as usual | |
| Outcomes | Assessment: baseline and 4 weeks CRQ, 6MWT | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: random numbers table |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessments: not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | All outcomes appearing in the controlled trial registry (clinicaltrials.gov) seem to have been reported on in the paper |
| Other bias | Low risk | None reported |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: community and hospital care in West London Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 69.9 ± 9.6; CG: 69.68 ± 10.4 Gender (M/F): RG: 30/31; CG: 30/31 FEV1 % (pred ± SD): RG: 42.9 ±15.5; CG: 48.9 ± 18.69 FEV1/FVC: RG:CG Current smoker (Y/N): RG: 18/61; CG: 12/61 Participants randomly assigned: Randomised: 122 | |
| Interventions | Pulmonary rehabilitation: outpatient followed by home package Aerobic exercise, ULE, LLE, educational material, home physio visits Duration: 4 weeks, 2 attendances per week (1 hour of education, 1 hour of physical training) followed by 3 monthly home visits Usual care: Control group received usual care from primary care physician | |
| Outcomes | Assessment: baseline and 6 months CRQ, hospital readmission rate | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned with the use of random numbers to intervention or control group |
| Allocation concealment (selection bias) | Unclear risk | Not informed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention were aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessments: not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Commenced: 122; outcome data for 104 Attrition: 18 (15%) |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Unclear risk | None reported |
| Methods | Study design: RCT (3 groups) | |
| Participants | Setting: out-patient Inclusion criteria: Exclusion criteria: Participant status: Age (years ± SD ): RG: 61 ± 6 ; CG: 63 ± 5 Gender (M/F): RG: 14/1; CG: 12/3 FEV1 % (pred ± SD): RG: 40.4 ±19.6; CG: 42.6 ± 8.8 Participants randomly assigned: Randomised: 32 Analysed: | |
| Interventions | Pulmonary rehabilitation: hospital-based outpatient pulmonary rehabilitation programmes (HRPa) are compared with those of a 12-week home care rehabilitation programme (HCRP) LLE, BE, PD, Edu, Psy Usual care: Control group received no rehabilitation therapy | |
| Outcomes | Assessment: baseline, 3 months, 6 months, 12 months and 18 months 4-Minute WT, ICET, interviews | |
| Notes | Utilised 3-month results for analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Lottery procedure used to determine which group participants allocated to. |
| Allocation concealment (selection bias) | Unclear risk | No information related to allocation concealment provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Started 50; finished 45; attrition at 3 months: 5 (10%) |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: pulmonary out-patient department in a central county district of Sweden Inclusion criteria:
Exclusion criteria:
Participant status: Age (years): RG: 66; CG: 64 Gender (M/F): RG: 3/9; CG: 10/4 FEV1 % (pred ± SD): RG: 35.1 ± 7.6; CG: 32.3 ± 9.5 Smokers: 3 in each group currently smoking Participants randomly assigned: Randomised: 30 | |
| Interventions | Pulmonary rehabilitation: out-patient programme (hospital based followed by home based), multi-disciplinary; comprising a physiotherapist, a dietician, an occupational therapist and a nurse. After 1 month, individualised home exercise added Aerobic exercise, ULE, LLE, breathing exercises, educational material, nutrition Duration: 12 weeks 2 days per week,1 hour long Usual care: Control group received none of the multi-disciplinary rehabilitation programmes and no care from multi-disciplinary professionals | |
| Outcomes | Assessment: baseline and 12 weeks 6MWD, SQRQ, hand grip strength and health perception, fatigue, functional limitations due to fatigue, functional performance and satisfaction | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation procedures were performed by an independent person from the research group, who took a random envelope from the prepared box with sealed envelopes |
| Allocation concealment (selection bias) | Low risk | For this purpose, we prepared 80 sealed opaque envelopes with assignment information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Data collection was performed by members of the rehabilitation group. Data collected were not blinded to the data collector |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 26/30 complete data for analysis 4/30 lost to follow-up = 13.33% |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: in-patient; France Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD ): RG: 59.6 ± 2.75; CG: 58.2 ± 1.8 Gender (M/F): RG: 7/3; CG: 8/2 FEV1/FVC: RG: 57.2; CG: 55.7 Participants randomly assigned: Randomised: 22 | |
| Interventions | Pulmonary rehabilitation: in-patient rehabilitation LLE, BE Usual care | |
| Outcomes | Assessment: baseline and 2 months ICET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: drawing lots Outcome assessments: not blinded |
| Allocation concealment (selection bias) | Unclear risk | No information related to allocation concealment provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessments: not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 18/20 (90%) completed |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 65.9 ± 8.8; CG: 67.2 ± 8.9 Gender (M/F): 71% male in each group FEV1 % (pred ± SD): RG: 58 ±17; CG: 60 ±15 FEV1/FVC: RG: 49 ±11; CG: 36.1 ± 26.4 Current smokers (%): RG: 33%; CG: 24% Participants randomly assigned: Randomised: 199 | |
| Interventions | Pulmonary rehabilitation: community (primary care setting) Standardised supervised rehabilitation phase and a 20-month active maintenance phase Aerobic exercise, ULE, LLE, educational material Duration: Initally 4-Month, followed by 20-month active maintenance phase (twice a day during 30 minutes) Usual care: received pharmacotherapy according to accepted guidelines | |
| Outcomes | Assessment: baseline and 4 months (immediately after initial intervention) SGRQ, cycle endurance test (CET), 6MWD, muscle strength (handgrip force (HGF), isometric quadriceps peak torque (QPT), maximal inspiratory mouth pressure (Pimax)), 17 body composition (FFM) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Care provided through a computerised procedure with concealed participant allocation |
| Allocation concealment (selection bias) | Low risk | Programme or usual care through a computerised procedure with concealed participant allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All measurements were assessed single-blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss = 24 (12%) (intervention: 15 (4.7%); control: 9 (9.2%)) 88% completed, so 12% attrition |
| Selective reporting (reporting bias) | Low risk | From protocol paper (http://clinicaltrials.gov/ct2/show/NCT00840892), outcomes matched those in the protocol paper |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: India Inclusion criteria:
Exclusion criteria: Participant status: Age (years): not provided Gender: not provided FEV1 %: not provided FEV1/FVC: not provided Participants randomly assigned: Randomised: 31 (15 control; 16 intervention) | |
| Interventions | Pulmonary rehabilitation: not informed of venue Aerobic exercise, ULE, LLE Duration: 8 weeks (5 days a week for 90 minutes) Usual care: Both groups had medication adjusted for 8 weeks | |
| Outcomes | Assessment: baseline 6-Minute walk test (Only relevant test) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No Information |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition reported |
| Selective reporting (reporting bias) | Unclear risk | Insufficent details provided |
| Other bias | High risk | Very superficial information available in relation to the study, precluding good quality assessment |
| Methods | Study design: RCT (3 groups): SIMT group received threshold inspiratory muscle trainer and exercise programme, exercise training group and control randomly matched to 3 groups according to the following criteria: age; FEV1; and FEV1/FVC | |
| Participants | Setting: out-patient; Isreal Inclusion criteria:
Exclusion criteria: Participant status: Age (years ± SD): RG: 64.4 ± 3; CG: 62.3 ± 2.4 Gender (M/F): RG: 6/6; CG: 5/7 FEV1 % (pred ± SD): RG: 32.8 ± 3; CG: 39.2 ± 2.8 Participants randomly assigned: Randomised: 24 | |
| Interventions | Pulmonary rehabilitation: out-patient (hospital) Performed under the supervision of a physiotherapist LLE, ULE, IMT, BE Usual care: no additional treatment | |
| Outcomes | Assessment: baseline and 6 months 12-Minute WT, ICET, SSCET | |
| Notes | 1 exercise only group used in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: random numbers table |
| Allocation concealment (selection bias) | Unclear risk | No information related to allocation concealment provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow-up |
| Selective reporting (reporting bias) | High risk | No trial registration protocol was found. Results of SGRQ not available |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (3 groups) High-intensity group Anaerobic threshold group Control group | |
| Participants | Setting: out-patient clinic in China Inclusion criteria:
Exclusion criteria:
Participant status: Age (years± SD): RG: [ATG: 67 ± 7; HIG: 68 ± 7]; CG: 66 ± 10 Gender (M/F): all male with exception of 1 FEV1% (pred ± SD): RG:[ ATG: 46 ± 10; HIG: 50 ± 14;] CG: 52 ± 14 Participants randomly assigned: Randomised: 41 (high-intensity group: 17; anaerobic threshold group: 15; control group: 9) Analysed: | |
| Interventions | Pulmonary rehabilitation: bicycle exercise training Aerobic exercise, LLE Duration: 12 weeks, 2 days a week Usual care | |
| Outcomes | Assessment: baseline and 12 weeks SGRQ, Borg/Max Oxygen Intake | |
| Notes | No results available for the SGRQ | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No Information |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 54 randomly assigned, 13 lost Attrition: 24% |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Methods | Study design: RCT (2 groups), stratified | |
| Participants | Setting: home based Inclusion criteria:
Exclusion criteria:
Participant status: Age (years ± SD): RG: 64 ± 5; CG: 62 ± 5 Gender (M/F): RG: 23/5; CG: 14/1 FEV1% (pred ± SD): RG: 44 ± 11; CG: 45 ± 9 FEV1/FVC (± SD): RG: 39 ± 8; CG: 36 ± 7 Participants randomly assigned: Randomised: 45 (RG: 30; CG: 15) | |
| Interventions | Pulmonary rehabilitation: out-patient clinic and home based: progressive physiotherapy programme LLE, ULE, IMT, BE, Edu, Psy, nurse home visited In addition, participants had to practice twice a day for half an hour at home Usual care: Control group did not follow the above mentioned protocol | |
| Outcomes | Assessment: baseline and 12 weeks 6-Minute WT, ICET | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: stratified randomisation |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 43/45 = 95.6% completed Attrition rate: 4.4% |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| ||
| Methods | Study design: RCT (2 groups) | |
| Participants | Setting: home-based affiliated central hospital of Jilin Medical College, China Inclusion criteria:
Exclusion criteria:
Participant status: Age (years± SD): RG: 54 ±6; CG: 54 ± 6 Gender (M/F): RG: 22/3; CG: 21/4 FEV1% (pred ± SD): RG: 41.8 ± 15; CG: 40 ± 16.5 FEV1/FVC(±SD): RG: 40.3 ± 9.3; CG: 42.3 ± 12.1 Participants randomly assigned: Randomised: 50 | |
| Interventions | Pulmonary rehabilitation: 1 home rehabilitation walking programme; training intensity was individually determined LLE Usual care: Control group participants (medical treatment alone) also made visits to the hospital every 2 weeks for clinical checkup | |
| Outcomes | Assessment: baseline and 12 weeks ICE, SWT, dyspnoea, lung function, blood gas | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation process: random numbers table |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | As a result of the nature of the intervention, both participants and those delivering the intervention would be aware of allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessments: not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No mention of attrition |
| Selective reporting (reporting bias) | Low risk | No trial registration protocol was found. However it would seem that all outcomes stated in the study were measured |
| Other bias | Low risk | None noted |
| Study | Reason for exclusion |
|---|---|
| |
| Akinci 2011 | Not a randomised controlled trial |
| Ambrosino 1981 | Experimental group did not receive exercise training |
| Ambrosino 2006 | Control group does not receive 'usual care' |
| Amin 2011 | Control group does not receive 'usual care' |
| Arnadottir 2001 | Control group does not receive 'usual care' |
| Backer 2003 | Control group does not receive 'usual care' |
| Bauldoff 1996 | Control group does not receive 'usual care' |
| Bauldoff 2002 | Wrong aim |
| Behnke 2002 | No control group |
| Behnke 2002a | Control group does not receive 'usual care' |
| Behnke 2003 | No control group |
| Bernard 1999 | Control group does not receive 'usual care' |
| Berry 1996 | Control group does not receive 'usual care' |
| Bjerre-Jepsen 1981 | No physical exercise component |
| Bourbeau 2000 | No physical exercise component |
| Bourjeily-Habr 2002 | No physical exercise component |
| Breyer 2010 | Control group does not receive 'usual care' |
| Brooks 2000 | Control group does not receive 'usual care' |
| Böhning 1990 | Wrong comparison |
| Cai 2003 | No physical exercise component |
| Carrieri-Kohlman 96 | Control group does not receive 'usual care' |
| Cegla 2002 | No physical exercise component |
| Chen 2011 | Control group does not receive 'usual care' |
| Ciric 2008 | Not a randomised controlled trial |
| Clark 2000 | FEV1 higher than 70% of predicted |
| Cockcroft 1985 | Control group does not receive 'usual care' |
| Coppoolse 1999 | Control group does not receive 'usual care' |
| Covey 2004 | Not a randomised controlled trial (review article) |
| Cox 1993 | Not a randomised controlled trial |
| de Blasio 2000 | Not a randomised controlled trial (editorial) |
| de Lucas Ramos 1998 | Experimental group does not receive exercise training |
| Dekhuijzen 1990 | Control group does not receive 'usual care' |
| Dekhuijzen 1991 | Control group does not receive 'usual care' |
| Demir-Deriven 2001 | Control group does not receive 'usual care' |
| Demir-Deriven 2002 | Wrong comparison (men compared with women) |
| Dewse 1998 | Not a randomised controlled trial (review article) |
| Di Marzo 2000 | No physical exercise component |
| Downes Vogel 2002 | No physical exercise component |
| Dushianthan 2009 | Not a randomised controlled trial (review article) |
| Egan 2012 | Not a randomised controlled trial |
| Ellum 2002 | Wrong comparison (effect of posture on dyspnoea) |
| Emtner 1998 | Not COPD |
| Epstein 1997 | Control group does not receive 'usual care' |
| Esteve 1996 | Control group does not receive 'usual care' |
| Fan 2008 | Control group does not receive 'usual care' |
| Foglio 2001 | Control group does not receive 'usual care' |
| Gadoury 2005 | Control group does not receive 'usual care' |
| Gale 2009 | Not a randomised controlled trial |
| Garuti 2010 | Not a randomised controlled trial (review article) |
| Gautier 1998 | Control group does not receive 'usual care' |
| Gautier 2002 | Control group does not receive 'usual care' |
| Ghanem 2010 | Participants not clearly 4 weeks post exacerbation |
| Gimenez 2000 | Control group does not receive 'usual care' Quasi-randomisation |
| Girodo 1992 | Not COPD |
| Goldman 1997 | FEV1 is higher than 70% predicted |
| Gormley 1993 | Control group does not receive 'usual care' |
| Gosselink 1990 | Control group does not receive 'usual care' |
| Green 1999 | Control group does not receive 'usual care' |
| Griffiths 1996 | Control group does not receive 'usual care' |
| Grosbois 1999 | Control group does not receive 'usual care' |
| Gu 2011 | No physical exercise component |
| Guell 2006 | Control group does not receive 'usual care' |
| Harver 1989 | Experimental group did not receive exercise training |
| Hawkins 1999 | No physical exercise component |
| Hentschel 2002 | Control group does not receive 'usual care' |
| Holland 2003 | Control group does not receive 'usual care' |
| Hospes 2009 | No physical exercise component |
| Houchen 2011 | Control group does not receive 'usual care' |
| Innocenti 2000 | Control group does not receive 'usual care' |
| Jensen 1983 | No physical exercise component |
| Johnson 2000 | Control group does not receive 'usual care' |
| Jungblut 2007 | Not a randomised controlled trial |
| Kaplan 1990 | Control group does not receive 'usual care' |
| Katsura 2000 | Control group does not receive 'usual care' |
| Kurabayashi 1998 | Experimental group does not receive exercise training |
| Kurabayashi 2000 | Experimental group does not receive exercise training |
| Larson 1999 | Control group does not receive 'usual care' |
| Lathlean 2008 | Randomisation unclear |
| Laukandt 1998 | Control group does not receive 'usual care' |
| Levine 1986 | Wrong comparison |
| Lewczuk 1998 | Not a randomised controlled trial |
| Li 2002 | No physical exercise component |
| Liu 2002 | Randomisation unclear |
| Lotshaw 2003 | Control group does not receive 'usual care' |
| Ma 2002 | Control group does not receive 'usual care' |
| Mador 2002 | Healthy controls |
| Mador 2004 | Control group does not receive 'usual care' |
| Make 2000 | Non-randomised comparison |
| Martinez 1993 | Control group does not receive 'usual care' |
| McKeogh 2012 | Control group does not receive 'usual care' |
| Morgan 1999 | Not a randomised controlled trial (review) |
| Moros Garcia 1996 | Not randomised |
| Morris 2003 | Control group does not receive 'usual care' |
| MTU 2003 | Systematic review |
| Murphy 2004 | Control group does not receive 'usual care' |
| Myers 2000 | Enhancement strategy |
| Na 2005 | Not a randomised controlled trial |
| Nasilowski 2011 | Not a randomised controlled trial |
| Nava 1998 | Unstable patients (wrong population) |
| Ndundu 2001 | Case series |
| Neder 2002 | Control group does not receive 'usual care' |
| Newall 2000 | Control group does not receive 'usual care' |
| Nguyen 2005 | Control group does not receive 'usual care' |
| Ninot 2011 | Outcomes measured longer than 3 months after the end of the intervention |
| Nosworthy 1992 | Control group does not receive 'usual care' |
| Nygren-Bonnier 2002 | Control group does not receive 'usual care' |
| O'Hara 1987 | Not a randomised controlled trial |
| Ortega 2002 | Control group does not receive 'usual care' |
| Patessio 1994 | Control group does not receive 'usual care' |
| Petersen 2008 | Control group does not receive 'usual care' |
| Piantadosi 2000 | No randomised comparison between PR and control group |
| Pison 2001 | Not a randomised controlled trial (review article) |
| Pison 2008 | Control group does not receive 'usual care' |
| Pitta 2004 | Not a randomised controlled trial |
| Ponsioen 2010 | Not a randomised controlled trial (review article) |
| Prince 1989 | Control group does not receive 'usual care' |
| Probst 2003 | Acute effect of walking aid on exercise capacity |
| Proshchaev 2009 | Control group does not receive 'usual care' |
| Puente 1996 | 2 types of training compared |
| Raschke 1990 | Not randomised |
| Regiane Resqueti 2007 | Control group does not receive 'usual care' |
| Reilly 2000 | NETT trial does not meet entry criteria for the review |
| Riario-Sforza 2009 | Randomisation unclear |
| Ries 1986 | Control group does not receive 'usual care' |
| Ries 1988 | Control group does not receive 'usual care' |
| Ries 1995 | Control group does not receive 'usual care' |
| Roberts 1999 | Control group does not receive 'usual care' |
| Rooyackers 1996 | Control group does not receive 'usual care' |
| Rudkin 1997 | Control group does not receive 'usual care' |
| Santiworakul 2009 | Randomisation unclear |
| Sassi-Dambron 1995 | Experimental group does not receive exercise training |
| Saunders 1965 | No physical exercise component |
| Scherer 1998 | Control group does not receive 'usual care' |
| Scorsone 2010 | Control group does not receive 'usual care' |
| Semenyuk 2007 | No physical exercise component |
| Serres 1997 | Inadequate duration (shorter than 4 weeks) |
| Sewell 2005 | Control group does not receive 'usual care' |
| Sinclair 1980 | Not a randomised controlled trial |
| Sindhwani 2011 | Not a randomised controlled trial |
| Sivori 1998 | Control group does not receive 'usual care' |
| Solanes Garcia 2004 | Randomisation unclear |
| Sparrow 1997 | Control group does not receive 'usual care' |
| Spruit 2001 | Control group does not receive 'usual care' |
| Steele 2008 | Control group does not receive 'usual care' |
| Stellefson 2009 | Not an exercise programme |
| Sudo 1997 | Control group does not receive 'usual care' |
| Sugawara 2007 | Control group does not receive 'usual care' |
| Sun 2003 | No physical exercise component |
| Swerts 1990 | Control group does not receive 'usual care' |
| Taylor 2012 | Not an exercise programme |
| Toevs 1984 | Control group does not receive 'usual care' |
| Troosters 1999 | Not a randomised controlled trial (review article) |
| Tsang 2001 | Control group does not receive 'usual care' |
| Ubaidullayev 1990 | No physical exercise component |
| Vargas 1998 | No physical exercise component |
| Vogiatzis 1999 | Treatment allocation not randomised |
| Vogiatzis 2001 | Control group does not receive 'usual care' |
| Vogiatzis 2002 | Control group does not receive 'usual care' |
| Wadell 2005 | Not a randomised controlled trial |
| Wadell 2013 | Control group does not receive 'usual care' |
| Wanke 1994 | Control group does not receive 'usual care' |
| Wedzicha 1998 | Control group does not receive 'usual care' |
| Weiner 1992a | Not COPD |
| Wen 2004 | Participants not clearly 4 weeks post exacerbation and length of intervention unclear |
| White 2002 | Control group does not receive 'usual care' |
| Worth 1985 | Not randomised |
| Xu 2010 | Length of programme unclear |
| Yamanaka 2009 | Not a randomised controlled trial |
| Yan 1996 | Experimental group does not receive exercise training |
| Yosbauran 1996 | Control group does not receive 'usual care' |
| Zanini 2002 | Control group does not receive 'usual care' |
| Zhang 2008 | No physical exercise component |
| Methods | 3 groups |
| Participants | 58 participants |
| Interventions | Pulmonary rehab: aerobic exercise group; aerobic exercise plus isotonic strengthening exercise group; control group with no exercise Duration: 3 times per week for 12 weeks Usual care: not known |
| Outcomes | Assessment: baseline and 12 weeks Exercise performance (measured by Bruce exercise tolerance test), 6MWT, dyspnoea scores, SGRQ, SF-36, BMI and pulmonary function |
| Notes | Not possible to establish contact with study authors |
| Methods | Not known |
| Participants | RCT (2 groups) |
| Interventions | Pulmonary rehabilitation: indoor aerobic training Duration: 3 days per week, 60 minutes each time, for 6 months Usual care: not known |
| Outcomes | Spirometry, oxygen saturation, ambulatory blood pressure measurement, health-related quality of life (SF-12) |
| Notes | Not possible to establish contact with study authors |
| Methods | RCT (4 groups) |
| Participants | 57 participants |
| Interventions | Pulmonary rehabilitation: physical training Duration: not known Usual care: standardised medication |
| Outcomes | 6-Minute walk test, respiratory muscle strength, health-related quality of life (SF-36), lung function |
| Notes | Contact information: m_natalia1967@inbox.ru |
| Methods | RCT (3 groups) |
| Participants | 45 participants |
| Interventions | Pulmonary rehabilitation: a physical exercise programme Duration: not known |
| Outcomes | BMI, pulmonary function, 6MWT, shortness of breath, health-related quality of life (SF-36), systemic inflammation blood indicators, blood testosterone, muscle power and depression |
| Notes | Contact information: m_natalia1967@inbox.ru |
| |
| Methods | RCT (3 groups) |
| Participants | 89 patients with COPD, divided into groups according to severity of COPD |
| Interventions | Pulmonary rehabilitation: 2 different programmes used for 20 weeks Usual care: not known |
| Outcomes | Assessment: baseline and 20 weeks 6MWT, BODE Index, acute exacerbation frequency, Modified Medical Research Council Scale, BMI and pulmonary function (FEV1) |
| Notes | Not possible to establish contact with study authors |
| Trial name or title | Pulmonary rehabilitation or self-management (PRSM) for chronic obstructive pulmonary disease (COPD) |
| Methods | RCT (3 groups) Individual randomisation, blinded outcome assessment, 3-monthly follow-up assessments across a 12-month period and concurrent economic evaluation |
| Participants | Target of 85 per group |
| Interventions | Stanford Chronic Disease Self-Management programme vs multi-factorial pulmonary rehabilitation group vs usual care provided by a GP |
| Outcomes | Primary outcome measure is St. George's Respiratory Disease Questionnaire Secondary outcome measures are measured by Frenchay Activities Index, International Physical Activity Questionnaire, the Hospital Anxiety and Depression Scale, the COPD Self-Efficacy scale and 2 physiological measures (forced vital capacity in 1 second and an incremental shuttle walk) measured at baseline and at 3-monthly intervals across 12 months. Also, spirometry and incremental shuttle walk at baseline and at 3 months |
| Starting date | April 2008 |
| Contact information | terrence.haines@monash.edu |
| Notes | Results not yet published |
| Trial name or title | Efficacy of an Eight-Week Pulmonary Rehabilitation in COPD Patients: An Experience of a Single Center in Turkey |
| Methods | RCT (2 groups) |
| Participants | 152 stable patients with COPD |
| Interventions | 8-Week pulmonary rehabilitation programme vs usual care |
| Outcomes | Assessment: at 8 weeks Walking distance, perceived dyspnoea, health-related quality of life, anxiety and depression |
| Starting date | Not known |
| Contact information | alev.gurgun@ege.edu.tr |
| Notes | Study still recruiting at the time of this review |
| |
| Trial name or title | Comparison of Repetitive Magnetic Stimulation (rMS) and Exercise Versus No Active Treatment on Quadriceps Function in Chronic Obstructive Pulmonary Disease (COPD) |
| Methods | RCT (3 groups) |
| Participants | 58 |
| Interventions | Pulmonary rehabilitation: supervised 2-hour resistance and endurance exercise programme twice a week for 8 weeks Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks Usual care: no intervention |
| Outcomes | Assessment at 8 weeks Lung function, fat-free mass, quadriceps strength, locomotion time and movement intensity over a 2-day period |
| Starting date | 2007 |
| Contact information | m.polkey@imperial.ac.uk |
| Notes | Results not yet published |
