Exercise-based rehabilitation for heart failure

  • Review
  • Intervention

Authors


Abstract

Background

Previous systematic reviews and meta-analyses consistently show the positive effect of exercise-based rehabilitation for heart failure (HF) on exercise capacity; however, the direction and magnitude of effects on health-related quality of life, mortality and hospital admissions in HF remain less certain. This is an update of a Cochrane systematic review previously published in 2010.

Objectives

To determine the effectiveness of exercise-based rehabilitation on the mortality, hospitalisation admissions, morbidity and health-related quality of life for people with HF. Review inclusion criteria were extended to consider not only HF due to reduced ejection fraction (HFREF or 'systolic HF') but also HF due to preserved ejection fraction (HFPEF or 'diastolic HF').

Search methods

We updated searches from the previous Cochrane review. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue1, 2013) from January 2008 to January 2013. We also searched MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and PsycINFO (Ovid) (January 2008 to January 2013). We handsearched Web of Science, bibliographies of systematic reviews and trial registers (Controlled-trials.com and Clinicaltrials.gov).

Selection criteria

Randomised controlled trials of exercise-based interventions with six months' follow-up or longer compared with a no exercise control that could include usual medical care. The study population comprised adults over 18 years and were broadened to include individuals with HFPEF in addition to HFREF.

Data collection and analysis

Two review authors independently screened all identified references and rejected those that were clearly ineligible. We obtained full-text papers of potentially relevant trials. One review author independently extracted data from the included trials and assessed their risk of bias; a second review author checked data.

Main results

We included 33 trials with 4740 people with HF predominantly with HFREF and New York Heart Association classes II and III. This latest update identified a further 14 trials. The overall risk of bias of included trials was moderate. There was no difference in pooled mortality between exercise-based rehabilitation versus no exercise control in trials with up to one-year follow-up (25 trials, 1871 participants: risk ratio (RR) 0.93; 95% confidence interval (CI) 0.69 to 1.27, fixed-effect analysis). However, there was trend towards a reduction in mortality with exercise in trials with more than one year of follow-up (6 trials, 2845 participants: RR 0.88; 95% CI 0.75 to 1.02, fixed-effect analysis). Compared with control, exercise training reduced the rate of overall (15 trials, 1328 participants: RR 0.75; 95% CI 0.62 to 0.92, fixed-effect analysis) and HF specific hospitalisation (12 trials, 1036 participants: RR 0.61; 95% CI 0.46 to 0.80, fixed-effect analysis). Exercise also resulted in a clinically important improvement superior in the Minnesota Living with Heart Failure questionnaire (13 trials, 1270 participants: mean difference: -5.8 points; 95% CI -9.2 to -2.4, random-effects analysis) - a disease specific health-related quality of life measure. However, levels of statistical heterogeneity across studies in this outcome were substantial. Univariate meta-regression analysis showed that these benefits were independent of the participant's age, gender, degree of left ventricular dysfunction, type of cardiac rehabilitation (exercise only vs. comprehensive rehabilitation), mean dose of exercise intervention, length of follow-up, overall risk of bias and trial publication date. Within these included studies, a small body of evidence supported exercise-based rehabilitation for HFPEF (three trials, undefined participant number) and when exclusively delivered in a home-based setting (5 trials, 521 participants). One study reported an additional mean healthcare cost in the training group compared with control of USD3227/person. Two studies indicated exercise-based rehabilitation to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs) and life-years saved.

Authors' conclusions

This updated Cochrane review supports the conclusions of the previous version of this review that, compared with no exercise control, exercise-based rehabilitation does not increase or decrease the risk of all-cause mortality in the short term (up to 12-months' follow-up) but reduces the risk of hospital admissions and confers important improvements in health-related quality of life. This update provides further evidence that exercise training may reduce mortality in the longer term and that the benefits of exercise training on appear to be consistent across participant characteristics including age, gender and HF severity. Further randomised controlled trials are needed to confirm the small body of evidence seen in this review for the benefit of exercise in HFPEF and when exercise rehabilitation is exclusively delivered in a home-based setting.

Résumé scientifique

Réadaptation par l'exercice dans l'insuffisance cardiaque

Contexte

Les précédentes revues systématiques et méta-analyses montrent clairement l'effet positif de la réadaptation par l'exercice pour l'insuffisance cardiaque sur la capacité d'exercice ; cependant, le sens et l'ampleur des effets sur la qualité de vie liée à la santé, la mortalité et les hospitalisations dans l'insuffisance cardiaque sont moins certains. Ceci est une mise à jour d'une revue systématique Cochrane publiée précédemment en 2010.

Objectifs

Déterminer l'efficacité de la réadaptation par l'exercice sur la mortalité, les hospitalisations, la morbidité et la qualité de vie liée à la santé pour les personnes souffrant d'insuffisance cardiaque. Les critères d'inclusion de la revue ont été étendues pour prendre en compte non seulement l'insuffisance cardiaque à fraction d'éjection réduite (ICFER ou « insuffisance cardiaque systolique »), mais également l'insuffisance cardiaque à fraction d'éjection préservée (ICFEP ou « insuffisance cardiaque diastolique »).

Stratégie de recherche documentaire

Nous avons mis à jour les recherches de la précédente revue Cochrane. Nous avons effectué des recherches dans le registre Cochrane des essais contrôlés (CENTRAL) (numéro 1, 2013) de janvier 2008 à janvier 2013. Nous avons également effectué des recherches dans MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) et PsycINFO (Ovid) (de janvier 2008 à janvier 2013). Nous avons effectué une recherche manuelle dans le Web of Science, les bibliographies des revues systématiques et dans des registres d'essais (Controlled-trials.com Et Clinicaltrials.gov).

Critères de sélection

Essais contrôlés randomisés sur des interventions basées sur des exercices avec un suivi de six mois ou plus comparées à des témoins sans exercices qui pouvaient inclure les soins médicaux habituels. La population étudiée se composait d'adultes de plus de 18 ans et a été élargie pour inclure les personnes atteintes de l'ICFEP en plus de l'ICFER.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment passé au crible toutes les références identifiées et exclu celles qui étaient clairement inéligibles. Nous avons obtenu les documents complets des essais potentiellement pertinents. Un auteur de la revue a indépendamment extrait les données des essais inclus et évalué leur risque de biais ; un deuxième auteur de la revue a vérifié les données.

Résultats principaux

Nous avons inclus 33 essais totalisant 4 740 personnes souffrant d'insuffisance cardiaque, atteintes principalement de l'ICFER et des classes II et III de la New York Heart Association. Cette dernière mise à jour a identifié 14 essais supplémentaires. Le risque global de biais des essais inclus était modéré. Il n'y avait aucune différence dans la mortalité combinée entre la réadaptation par l'exercice versus témoin sans exercice dans les essais avec jusqu'à un an de suivi (25 essais, 1 871 participants : risque relatif (RR) 0,93 ; intervalle de confiance (IC) à 95 % 0,69 à 1,27, analyse à effets fixes). Cependant, il y avait une tendance à une réduction de la mortalité avec l'exercice dans les essais à plus d'un an de suivi (6 essais, 2 845 participants : RR 0,88 ; IC à 95 % 0,75 à 1,02, analyse à effets fixes). Par rapport au groupe témoin, l'exercice physique a réduit le taux d'hospitalisation globale (15 essais, 1 328 participants : RR 0,75 ; IC à 95 % 0,62 à 0,92, analyse à effets fixes) et spécifique à l'insuffisance cardiaque (12 essais, 1 036 participants : RR 0,61 ; IC à 95 % 0,46 à 0,80, analyse à effets fixes). L'exercice physique a également amené une amélioration cliniquement importante supérieure au questionnaire Minnesota Living with Heart Failure (13 essais, 1 270 participants : différence moyenne : -5,8 points ; IC à 95 % -9,2 à -2,4, analyse à effets aléatoires) - une mesure de la qualité de vie liée à la santé spécifique à la maladie. Toutefois, les niveaux d'hétérogénéité statistique entre les études sur ce critère de jugement étaient substantiels. Une analyse de méta-régression univariée a montré que ces bénéfices étaient indépendants de l'âge et du sexe des participants, du degré de dysfonctionnement ventriculaire gauche, du type de réadaptation cardiaque (exercice uniquement vs. réadaptation complète), de la dose moyenne de l'intervention d'exercice, de la durée de suivi, du risque global de biais et de la date de publication de l'essai. Au sein des études incluses, un petit ensemble de preuves sont favorables à la réadaptation par l'exercice pour l'ICFEP (trois essais, nombre de participants non défini) et lorsque celle-ci était exclusivement effectuée dans un contexte à domicile (5 essais, 521 participants). Une étude rapportait un coût supplémentaire moyen des soins de santé dans le groupe de l'entraînement par rapport au groupe témoin de 3 227 USD par personne. Deux études indiquaient que la réadaptation par l'exercice représentait une utilisation potentiellement rentable de ressources en termes de gains d'années de vie ajustées en fonction de la qualité (AVAQ) et d'années-vie économisées.

Conclusions des auteurs

Cette revue Cochrane mise à jour confirme les conclusions de la version précédente de cette revue que, par rapport à un témoin sans exercice, la réadaptation par l'exercice n'augmente ni ne réduit le risque de mortalité toutes causes confondues à court terme (jusqu'à 12 mois de suivi), mais réduit le risque d'hospitalisations et confère des améliorations importantes sur la qualité de vie liée à la santé. Cette mise à jour apporte en plus des preuves que l'exercice physique peut potentiellement réduire la mortalité à plus long terme et que les bénéfices de l'exercice physique semblent cohérents à travers les caractéristiques des participants dont l'âge, le sexe et la gravité de l'insuffisance cardiaque. D'autres essais contrôlés randomisés sont nécessaires pour confirmer le petit ensemble des preuves observées dans cette revue en faveur de l'exercice dans l'ICFEP et lorsque la rééducation par l'exercice était exclusivement effectuée dans un contexte à domicile.

摘要

心臟衰竭的運動復健

背景

先前的系統性文獻回顧和後設分析 (meta-analysis) 一致證實,心臟衰竭 (heart failure, HF) 的運動復健,對於運動能力 (exercise capacity) 具有正面影響;不過對HF患者的健康相關生活品質、死亡率和住院等,影響的方向和幅度則較不明確。本次文獻回顧旨在更新先前於2010年發表的考科藍系統性文獻回顧。

目的

判定運動復健對HF患者的死亡率、住院、罹病率和健康相關生活品質的影響。我們將本次文獻回顧的納入條件擴大,不僅考慮因射出分率 (ejection fraction) 降低而導致的HF (HFREF或「收縮性心臟衰竭」),也考慮射出分率正常的心臟衰竭 (HFPEF或「舒張性心臟衰竭」)。

搜尋策略

我們依據先前的考科藍文獻回顧更新搜尋,找尋2008年1月至2013年1月的考科藍對照試驗中央註冊 (Cochrane Central Register of Controlled Trials, CENTRAL) (2013年第1次發行),此外也搜尋MEDLINE (Ovid)、EMBASE (Ovid)、CINAHL (EBSCO) 和 PsycINFO (Ovid) (2008年1月至2013年1月)。我們也以人工的方式搜尋科學網站、系統性文獻回顧的參考書目和試驗註冊 (Controlled-trials.com和Clinicaltrials.gov)。

選擇標準

本次文獻回顧收錄隨機對照試驗,比較無運動介入的對照組和有運動介入的治療組,追蹤期為6個月以上,可能包含一般的醫療照護。試驗族群為18歲以上成人,除了HFREF的患者以外,也擴大納入HFPEF的患者。

資料收集與分析

由2位文獻回顧作者,獨立篩選所有已確認的參考文獻,並排除顯然不符合納入條件的資料。我們取得相關試驗的論文全文,由1位文獻回顧作者,獨立自納入試驗中萃取資料,並評估偏差風險;再由第2位文獻回顧作者負責核對資料。

主要結果

本次文獻回顧納入33篇試驗,包含4740名HF患者,主要為HFREF和紐約心臟學會 (New York Heart Association) 第2級和第3級的患者。最近期的更新進一步找到了14篇試驗。納入試驗的整體偏差風險為中等。追蹤長達1年的試驗顯示,運動復健組和無運動對照組的綜合死亡率並無差異 (25篇試驗,1871名受試者:風險比 [RR]為0.93;95%信賴區間 [CI]為0.69至1.27之間,固定效果 [fixed-effect] 分析)。不過追蹤超過1年的試驗則發現,運動組患者的死亡率有降低的趨勢 (6篇試驗,2845名受試者:RR為0.88;95% CI為0.75至1.02,固定效果分析)。相較於對照組,運動訓練可降低整體 (15篇試驗,1328名受試者:RR為0.75;95% CI為0.62至0.92,固定效果分析) 和HF特有 (12篇試驗,1036名受試者:RR為0.61;95% CI為0.46至0.80,固定效果分析) 的住院率。運動也可使患者的明尼蘇達心臟衰竭生活品質問卷 (Minnesota Living with Heart Failure questionnaire) (專門針對某種疾病測量健康相關生活品質的問卷),出現較佳的臨床重大改善 (13篇試驗,1270名受試者;平均差 [MD]:-5.8分;95% CI為 -9.2至 -2.4,隨機效果 [random-effect] 分析)。無論如何,對於此項結果,各項試驗皆具有相當明顯的統計異質性。單變項統合迴歸分析 (univariate meta-regression analysis) 的結果顯示,此項效益與患者的年齡、性別、左心室功能障礙的程度、心臟復健的類型 (只有運動和綜合復健)、運動介入的平均運動量、追蹤時間長短、整體偏差風險以及試驗發表日期無關。在我們所納入的試驗中,有少數證據支持運動復健有利於HFPEF (3篇試驗,患者人數不明),以及僅在家中進行運動復健 (5篇試驗,521名患者) 的作法。有1篇試驗指出,相較於對照組,運動訓練組患者的平均健康照護成本每人增加3227美元。有2篇試驗顯示,對於增加生活品質調整生命年數 (quality-adjusted life years, QALYs) 和拯救的生命年數 (life-years saved) 而言,運動復健可能是具成本效益的資源使用法。

作者結論

此次更新的考科藍文獻回顧結果,支持前一版的文獻回顧結果:相較於無運動介入的控制組,運動復健並不會增加或降低短期 (追蹤長達12個月) 的所有原因死亡 (all-cause mortality) 風險,但可降低住院風險,並顯著改善健康相關生活品質。此次更新提供進一步的證據,證實運動訓練可以降低長期死亡率,而且運動訓練的益處顯然遍及各種受試者特性,包括年齡、性別和HF嚴重度。未來必須進行隨機對照試驗,以確認本次文獻回顧所觀察到的少數證據,即運動對HFPEF的益處和僅在居家環境進行運動復健的優點。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本翻譯計畫由衛生福利部補助經費,臺北醫學大學實證醫學研究中心、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行

Resumo

Reabilitação baseada em exercícios para insuficiência cardíaca

Introdução

Revisões sistemáticas e metanálises prévias mostraram de maneira consistente o efeito positivo da reabilitação baseada em exercício para insuficiência cardíaca (IC) na capacidade de se exercitar. Porém ainda existem dúvidas quanto a esta intervenção em relação à direção e à magnitude dos seus efeitos na qualidade de vida relacionada à saúde, na mortalidade e nas internações por IC. Esta é uma atualização de uma revisão sistemática Cochrane publicada originalmente em 2010.

Objetivos

Avaliar a efetividade da reabilitação baseada em exercícios para a mortalidade, internações, morbidade e qualidade de vida relacionada à saúde para pessoas com IC. Os critérios de inclusão da revisão foram ampliados e incluem não somente a IC com redução da fração de ejeção (ICFER ou “IC sistólica”), mas também com fração de ejeção normal (ICFEP ou “IC diastólica”).

Métodos de busca

Nós atualizamos as buscas da revisão Cochrane anterior. Pesquisamos as seguintes bases de dados: Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2013) de janeiro de 2008 a janeiro 2013. Nós também buscamos o MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) e o PsycINFO (Ovid) (de janeiro de 2008 a janeiro de 2013). Buscamos manualmente o Web of Science, bibliografias de revisões sistemáticas e plataformas de registros de ensaios (Controlled-trials.com e Clinicaltrials.gov).

Critério de seleção

Incluímos ensaios clínicos randomizados de intervenções baseadas em exercícios com seis meses de seguimento ou mais comparados com um controle sem exercício, que poderiam incluir o cuidado médico usual. Os participantes eram adultos, com mais de 18 anos, e os critérios foram ampliados para incluir indivíduos com ICFEP além daqueles com ICFER.

Coleta dos dados e análises

Dois autores, de forma independente, avaliaram as citações identificadas e excluíram aquelas que claramente não eram elegíveis. Obtiveram o texto completo de estudos potencialmente relevantes. Um autor de revisão extraiu os dados e avaliou a qualidade dos estudos incluídos, e um segundo autor confirmou essas informações.

Principais resultados

Nós incluímos 33 estudos, somando 4.740 pessoas com IC, predominantemente com ICFER e com classes II e III de acordo com a New York Heart Association. A última atualização identificou 14 estudos adicionais. O risco de viés geral dos estudos incluídos foi moderado. Não houve diferença na mortalidade combinada na comparação entre os grupos tratados com reabilitação baseada em exercícios versus o controle sem exercício, em estudos com até um ano de seguimento (25 estudos, 1.871 participantes, risco relativo, RR, 0,93, intervalo de confiança de 95%, 95% CI, 0,69 a 1,27, análise de efeito fixo). Entretanto, houve uma tendência deredução da mortalidade para os estudos com exercícios com mais de um ano de seguimento (6 estudos, 2.845 participantes, RR 0,88, 95% CI 0,75 a 1,02, análise de efeito fixo). Em comparação com o controle, o treinamento com exercícios reduziu a taxa geral de hospitalizações (15 estudos, 1.328 participantes, RR 0,75, 95% CI 0,62 a 0,92, análise de efeito fixo) e especificamente de hospitalizações por IC (12 estudos, 1.036 participantes, RR 0,61, 95% CI 0,46 a 0,80, análise de efeito fixo). O exercício também resultou em uma melhora clínica importante no Questionário para Insuficiência Cardíaca Minnesota Living, uma medida de qualidade de vida para doenças específicas (13 estudos, 1.270 participantes, diferença média -5,8 pontos, 95% CI -9,2 a -2,4, análise de efeito aleatório). Entretanto, para esse desfecho, a heterogeneidade estatística foi substancial entre os estudos. Uma análise univariada de meta-regressão mostrou que esses benefícios eram independentes de idade, gênero, nível da disfunção do ventrículo esquerdo, tipo de reabilitação cardíaca (exercício somente versus reabilitação compreensiva), dose média de intervenção com exercício, duração e seguimento, risco geral de viés e data de publicação do estudo. Entre os estudos incluídos, um pequeno corpo de evidência apoiou a reabilitação baseada em exercícios para ICFEP (três estudos, número de participantes indefinido) e quando a intervenção foi realizada apenas em domicílio (5 estudos, 521 participantes). Um estudo relatou custo médio adicional com cuidados de saúde de US$3.227/pessoa no grupo com treinamento em comparação com o controle. Dois estudos indicaram que a reabilitação baseada em exercícios pode representar um uso custo-efetivo de recursos em termos de ganho em qualidade de vida ajustada em anos (QLAA) e anos de vida salvos.

Conclusão dos autores

Esta atualização da revisão Cochrane apoia as conclusões da versão anterior de que comparada com um grupo controle com nenhum exercício, a reabilitação baseada em exercício não aumenta ou diminui o risco de mortalidade por todas as causas em curto prazo (até 12 meses de seguimento), mas reduz o risco de internações hospitalares e confere melhoras importantes na qualidade de vida relacionada à saúde. Esta atualização fornece evidências adicionais de que o treinamento com exercícios pode reduzir a mortalidade a longo prazo e que os benefícios do treinamento parecem ser consistentes não importando as características dos participantes, tais como idade, gênero e gravidade da IC. Mais ensaios clínicos randomizados são necessários para confirmar o pequeno corpo de evidência visto nesta revisão sobre os benefícios do exercício em ICFEP e quando a reabilitação de exercício é exclusivamente realizada em domicílio.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Maíra T. Parra).

Plain language summary

Exercise-based rehabilitation for heart failure

Background

People with heart failure experience marked reductions in their exercise capacity, which has detrimental effects on their activities of daily living, health-related quality of life and ultimately their hospital admission rate and mortality.

Study characteristics

We searched the scientific literature for randomised controlled trials (experiments in which two or more interventions, possibly including a control intervention or no intervention, are compared by being randomly allocated to participants) looking at the effectiveness of exercise-based treatments compared with no exercise on heart failure in adults over 18 years of age. The inclusion criteria of this updated review were extended to consider not only HF due to reduced ejection fraction (HFREF or 'systolic HF') (ejection fraction is a measure of how well your heart is pumping), but also HF due to preserved ejection fraction (HFPEF or 'diastolic HF'). The search is current to January 2013.

Key results

We found 33 RCTs that included 4740 participants. The findings of this update are consistent with the previous (2010) version of this Cochrane review and show important benefits of exercise-based rehabilitation that include a reduction in the risk of hospital admissions due to HF and improvements in health-related quality of life compared with not undertaking exercise. There was a high level of variation across studies in health-related quality of life outcome. While the majority of evidence was for exercise-based rehabilitation in people with HFREF, this update did identify a broader evidence base that included higher risk (New York Heart Association class IV) and older people, people with HFPEF and more programmes conducted in a home-based setting. We found no evidence to suggest that exercise training programmes cause harm in terms of an increase in the risk of death in either the short or longer term. A small body of economic evidence was identified indicating exercise-based rehabilitation to be cost-effective. Further evidence is needed to understand the effect of exercise training in people with HFPEF better and the costs and effects of exclusively home-based exercise rehabilitation programmes.

Quality of evidence

The general lack of reporting of methods in the included trial reports made it difficult to assess their methodological quality and thereby judge their risk of possible bias.

Résumé simplifié

La réadaptation par l'exercice dans l'insuffisance cardiaque

Contexte

Les patients atteints d'insuffisance cardiaque souffrent de réductions marquées de leur capacité d'exercice, ce qui a des effets néfastes sur leurs activités de la vie quotidienne, la qualité de vie liée à la santé et finalement leur taux d'admission à l'hôpital et la mortalité.

Caractéristiques des études

Nous avons effectué des recherches dans la littérature scientifique pour des essais contrôlés randomisés (expériences dans lesquelles deux ou plusieurs interventions, comportant éventuellement une intervention de contrôle ou l'absence d'intervention, sont comparées en étant assignées de manière aléatoire aux participants) examinant l'efficacité des traitements basés sur l'exercice physique par rapport à l'absence d'exercice sur l'insuffisance cardiaque chez les adultes de plus de 18 ans. Les critères d'inclusion de cette revue mise à jour ont été étendues pour prendre en compte non seulement l'insuffisance cardiaque due à la fraction d'éjection réduite (ICFER ou « insuffisance cardiaque systolique ») (la fraction d'éjection est une mesure de la capacité du cœur à pomper), mais également l'insuffisance cardiaque due à la fraction d'éjection préservée (ICFEP ou « insuffisance cardiaque diastolique »). Les recherches sont à jour jusqu'à janvier 2013.

Résultats principaux

Nous avons trouvé 33 ECR portant sur 4 740 participants. Les résultats de cette mise à jour sont cohérents avec la version précédente (2010) de cette revue Cochrane et montrent des effets bénéfiques importants de la réadaptation par l'exercice, qui incluent une réduction du risque d'hospitalisations pour cause d'insuffisance cardiaque et les améliorations de qualité de vie liée à la santé, par rapport à l'absence d'exercice. Il y avait un niveau élevé de variation entre les études dans le critère de jugement de la qualité de vie liée à la santé. Bien que la majorité des preuves concernaient la réadaptation par l'exercice chez les personnes atteintes de l'ICFER, cette mise à jour a identifié un corpus de preuves plus vaste qui comprend des personnes à risque plus élevé (New York Heart Association classe IV) et plus âgées, des personnes atteintes de l'ICFEP ainsi que plus de programmes réalisés dans un contexte à domicile. Nous n'avons trouvé aucune preuve suggérant que les programmes d'exercices pourraient entraîner des préjudices en termes d'une augmentation du risque de décès dans le court ou long terme. Un petit ensemble de preuves économiques a été identifié, qui indiquait que la réadaptation par l'exercice avait un bon rapport coût/efficacité. Des preuves supplémentaires sont nécessaires pour mieux comprendre l'effet de l'exercice physique chez les personnes atteintes de l'ICFEP ainsi que les coûts et les effets des programmes de réadaptation par l'exercice menés exclusivement à domicile.

Qualité des preuves

En raison du manque général de notification des méthodes dans les rapports d'essais inclus, il a été difficile d'évaluer leur qualité méthodologique et ainsi de juger leur risque de la possibilité de biais.

Notes de traduction

Traduit par: French Cochrane Centre 16th July, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

Laienverständliche Zusammenfassung

Übungsbasierte Rehabilitation bei Herzinsuffizienz

Hintergrund

Menschen mit einer Herzinsuffizienz (Herzschwäche) erfahren deutliche Einschränkungen ihrer Belastungsfähigkeit, die sich nachteilig auf Aktivitäten des täglichen Lebens, die gesundheitsbezogene Lebensqualität sowie letztendlich die Häufigkeit von Krankenhausaufenthalten und die Sterblichkeit auswirken.

Studienmerkmale

Wir haben die wissenschaftliche Literatur nach randomisierten kontrollierten Studien durchsucht, die die Wirksamkeit übungsbasierter Behandlungen im Vergleich mit keiner Übungsbehandlung für über 18-jährige Erwachsene mit Herzinsuffizienz untersucht haben. (Randomisierte kontrollierte Studien (RCTs) sind Untersuchungen, in denen zwei oder mehrere Behandlungsmaßnahmen unter Einschluss einer Kontrollbehandlung (einer anderen Behandlung) oder keiner Behandlung verglichen werden, und in denen die Studienteilnehmer den verschiedenen Behandlungen zufällig zugeordnet werden). Die Einschlusskriterien für diese aktualisierte Übersichtsarbeit wurden erweitert, um nicht nur die Herzinsuffizienz infolge einer verminderten Auswurfleistung (HFREF oder ‚systolische HI‘) (Auswurfleistung ist ein Maß, wie gut ihr Herz pumpt), sondern auch die Herzinsuffizienz infolge einer unveränderten Auswurfleistung (HFPEF oder ‚diastolische HI‘) zu berücksichtigen. Die Suchergebnisse sind auf dem Stand von Januar 2013.

Hauptergebnisse

Wir haben 33 RCTs mit insgesamt 4740 Teilnehmern gefunden. Die Ergebnisse dieser Aktualisierung stimmen mit denen der vorherigen (2010) Version dieses Cochrane Reviews überein. Sie zeigen bedeutende Vorteile einer übungsbasierten Rehabilitation im Vergleich zu keiner Durchführung von Übungen auf, einschließlich einer Verringerung des Risikos von Krankenhausaufenthalten aufgrund der Herzinsuffizienz und Verbesserungen der gesundheitsbezogenen Lebensqualität. In ihren Ergebnissen zur gesundheitsbezogenen Lebensqualität unterschieden sich die Studien erheblich. Während die meiste Evidenz (der wissenschaftliche Beleg) für die übungsbezogene Rehabilitation von Menschen mit HFREF galt, hat diese Aktualisierung auch eine breitere Evidenzlage aufgezeigt, die eine höhere Risikogruppe (New York Heart Association Grad IV), ältere Menschen und Menschen mit HFPEF einschließt, sowie mehr Programme, die im häuslichen Umfeld durchgeführt wurden. Wir haben keine Evidenz gefunden, die darauf hindeutet, dass Übungsprogramme kurz- oder längerfristig schädliche Auswirkungen im Sinne eines Anstiegs des Sterberisikos verursachen. Es gab einige wenige Belege zur Wirtschaftlichkeit, die darauf hindeuten, dass eine übungsbasierte Rehabilitation kosteneffektiv (wirtschaftlich) ist. Weitere Belege sind erforderlich, um die Wirksamkeit von Übungen für Menschen mit HFPEF sowie die Kosten und Auswirkungen von ausschließlich im häuslichen Umfeld durchgeführten Übungsprogrammen besser zu verstehen.

Qualität der Evidenz

Die insgesamt mangelhafte Beschreibung der methodischen Vorgehensweise in den eingeschlossenen Studienberichten erschwert die Beurteilung der methodischen Qualität und somit das Risiko für mögliche Verzerrungen (engl. Bias; eine Verfälschung der Ergebnisse).

Anmerkungen zur Übersetzung

übersetzt von M. Lohkamp & C. Braun, Aug. 2014

淺顯易懂的口語結論

心臟衰竭的運動復健

背景

心臟衰竭患者的運動能力會顯著下降,對他們的日常活動、健康相關生活品質和最終的住院率及死亡率,都具有不利的影響。

試驗特色

我們搜尋科學文獻,找尋隨機對照試驗 (採用2種以上介入的實驗,可能包含對照介入或無介入,將受試者隨機分配至不同的介入組,然後針對各介入組進行比較),探究相對於無運動介入,運動治療對18歲以上心臟衰竭成人患者的療效。我們將此次文獻回顧更新的納入條件擴大,不僅考慮因射出分率降低而導致的HF (HFREF或「收縮性心臟衰竭」) (射出分率是指心臟泵注血液的能力),也考慮射出分率正常的心臟衰竭 (HFPEF或「舒張性心臟衰竭」)。搜尋工作直至2013年1月為止。

重要結果

我們找到33篇RCT,包含4740名受試者。此次文獻回顧更新結果,與前一版 (2010年) 的考科藍文獻回顧結果一致,並證實運動復健具有重要益處。相對於未接受運動介入,運動復健可降低患者因HF住院的風險,並改善健康相關生活品質。各項試驗的健康相關生活品質結果,具有相當高的變異性。儘管大多數的運動復健證據,是以HFREF患者為主,但此次更新確實發現更廣泛的證據基礎,包括高風險 (紐約心臟學會第4級) 和老年患者、HFPEF患者,以及更多在居家環境中執行的方案。我們並未發現長期或短期運動訓練方案,會導致死亡風險增加,但發現一些經濟上的證據,顯示運動復健具有成本效益。必須取得進一步的證據,以瞭解運動訓練對HFPEF患者的益處,以及僅在居家環境執行復健方案的成本和療效。

證據品質

由於我們所納入的試驗,普遍皆未報告所採用的方法,以致很難評估它們的方法學品質,並判斷可能的偏差風險。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本翻譯計畫由衛生福利部補助經費,臺北醫學大學實證醫學研究中心、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行

எளியமொழிச் சுருக்கம்

இதய செயலிழப்பிற்கான உடற்பயிற்சி-சார்ந்த மறுவாழ்வு சிகிச்சை

பின்புலம்

இதய செயலிழப்பு கொண்ட மக்கள், அன்றாட வாழ்க்கை நடவடிக்கைகள், ஆரோக்கியம்-தொடர்பான வாழ்க்கைத் தரம் மற்றும் இறுதியில், அவர்களின் மருத்துவமனை அனுமதி விகிதம் மற்றும் இறப்பு ஆகியவற்றின் மேல் தீங்கு ஏற்படுத்தும் குறிப்பிடத்தக்க உடற்பயிற்சி திறன் குறைவுகளை அனுபவிப்பர்.

ஆய்வுப் பண்புகள்

இதய செயலிழப்பு கொண்ட 18 வயதிற்கு மேலுள்ள வயது வந்தோரில், சிகிச்சையின்மையோடு ஒப்பிடப்பட்ட உடற்பயிற்சி-சார்ந்த சிகிச்சைகளின் திறனைக் கண்டறிந்த சீரற்ற சமவாய்ப்பு கட்டுப்பாடு சோதனைகளுக்காக (இரண்டு அல்லது அதற்கு மேற்பட்ட தலையீடுகள் கொண்ட, தோராயமாக ஒரு கட்டுப்பாடு தலையீடு அல்லது எந்த தலையீடும் இல்லாமல், பங்கேற்பாளர்களுக்கு சீரற்ற முறையில் ஒதுக்கப்பட்டு ஒப்பிடுவது போன்றவற்றை கொண்ட சோதனைகள்) நாங்கள் அறிவியல் இலக்கியத்தை தேடினோம். இந்த மேம்படுத்தப்பட்ட திறனாய்வின் சேர்க்கை விதிமுறைகளில், குறைவான வெளியேற்ற கூற்றின் காரணமாக ஏற்பட்ட இதய செயலிழப்பு (ஹார்ட் பெயிலியர் ரெட்யுஸ்டு யெஜக்ஷன் ப்ராக்க்ஷன், ஹட்ச்ஏப்ஆர்இஏப், HFREF அல்லது, 'சிஸ்டோலிக் ஹட்ச்ஏப்' 'systolic HF’) (வெளியேற்ற கூறு என்பது உங்கள் இதயம் எவ்வளவு நன்றாக உந்துவிசை கொண்டுள்ளது என்பதின் அளவு) மட்டுமல்லாது பாதுகாக்கப்பட்ட வெளியேற்ற கூற்றின் (ஹார்ட் பெயிலியர் பிரிஸ்எர்வ்டு யெஜக்ஷன் ப்ராக்க்ஷன், ஹட்ச்ஏப் பிஇஏப், HFPEF அல்லது 'டயஸ்டோலிக் ஹட்ச்ஏப்' 'diastolic HF') காரணமாக ஏற்பட்ட இதய செயலிழப்பையும் கருத்தில் கொண்டு நீட்டிக்கப்பட்டுள்ளது. இத்தேடல் ஜனவரி 2013 வரை தற்போதையானது.

முக்கிய முடிவுகள்

4740 பங்கேற்பாளர்களை உள்ளடக்கிய 33 சீரற்ற சமவாய்ப்பு கட்டுப்பாடு சோதனைகளை நாங்கள் கண்டோம். இந்த மேம்படுத்தலின் கண்டுபிடிப்புகள், இந்த காக்குரேன் திறனாய்வின் முந்தைய (2010) பதிப்புடன் இசைவானதாக இருந்தது மற்றும் உடற்பயிற்சி மேற்கொள்ளாமையோடு ஒப்பிடுகையில் உடற்பயிற்சி-சார்ந்த மறுவாழ்வு இதய செயலிழப்பு காரணமான மருத்துவமனை அனுமதியின் ஆபாயத்தைக் குறைத்தல் மற்றும் ஆரோக்கியம்-தொடர்பான வாழ்க்கைத் தர மேம்பாடுகள் போன்ற முக்கியமான நன்மைகளை காட்டுகின்றன. ஆரோக்கியம்-தொடர்பான வாழ்க்கைத் தரத்தில், ஆய்வுகளுக்கிடையே உயர் மட்ட மாறுபாடுகள் இருந்தது. பெரும்பாலான சான்று ஹட்ச்ஏப்ஆர்இஏப், HFREF கொண்ட மக்கள் மத்தியில் உடற்பயிற்சி-சார்ந்த மறுவாழ்விற்கு இருந்த போதும், இந்த மேம்படுத்தல் அதிக அபாயம் கொண்ட (நியூயார்க் இதய சங்கம்-வர்க்கம் IV) மற்றும் வயதான மக்கள், ஹட்ச்ஏப் பிஇஏப், HFPEF கொண்ட மக்கள், மற்றும் வீடு-சார்ந்த அடிப்படையில் நடைபெற்ற அதிக திட்டங்கள் ஆகியவற்றை உள்ளடக்கிய ஒரு பரந்த சான்று அடித்தளத்தை அடையாளம் கண்டது. உடற்பயிற்சி பயிற்றுவிப்பு திட்டங்கள் குறுகிய அல்லது நீண்ட-காலக் கட்டத்தில் மரண அபாயத்தின் அதிகரிப்பு அடிப்படையில் தீங்கை ஏற்படுத்தும் என்று பரிந்துரைக்க எந்த சான்றையும் நாங்கள் காணவில்லை. உடற்பயிற்சி-சார்ந்த மறுவாழ்வு குறைந்த செலவு-திறன் கொண்டது என்பதை குறிப்பிட்ட ஒரு சிறியளவு பொருளாதார சான்று அடையாளம் காணப்பட்டது. ஹட்ச்ஏப் பிஇஏப், HFPEF கொண்ட மக்களில், உடற்பயிற்சி பயிற்றுவிப்பின் விளைவைப் பற்றி புரிந்துக் கொள்ளவும் மற்றும் பிரத்தியேகமாக வீடு-சார்ந்த உடற்பயிற்சி மறுவாழ்வுத் திட்டங்களின் விளைவுகள் மற்றும் செலவுகள் பற்றி புரிந்துக் கொள்ள மேற்படியான சான்று தேவைப்படுகிறது.

சான்றின் தரம்

சேர்க்கப்பட்டிருந்த சோதனை அறிக்கைகளில், செயல்முறையியல் பற்றிய அறிக்கையின் பொதுவான பற்றாக்குறையால், செயல்முறையியல் தரம் மற்றும் அவற்றின் சாத்திய ஒருதலைச் சார்பு அபாயத்தை மதிப்பிடுவது கடினமாக்கப்பட்டது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழி பெயர்ப்பாளர்கள்: தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், ஸ்ரீகேசவன் சபாபதி.

Laički sažetak

Rehabilitacija za zatajenje srca koja se temelji na tjelovježbi

Dosadašnje spoznaje

Osobe sa zatajenjem srca imaju značajno smanjenje kapacitete za tjelovježbu, što ima negativan učinak na obavljanje aktivnosti u svakodnevnom životu, kvalitetu života vezanu za zdravlje i konačno može dovesti do povećanja broja primitaka u bolnicu i smrtnosti.

Značajke istraživanja

U ovom Cochrane sustavnom pregledu pretražena je znanstvena literatura kako bi se pronašla randomizirana kontrolirana istraživanja (pokusi u kojima se uspoređuju dvije ili više intervencija, u kojoj je jedna skupina kontrolna, a ponekad jedna skupina ne prima nikakvu intervenciju te se skupine uspoređuju nakon što se ispitanici nasumično podijele u skupine) u kojima je istražena djelotvorost tjelovježbe u usporedbi s izostankom tjelovježbe kod odraslih osoba sa zatajenjem srca. Kriteriji uključenja u ovom obnovljenom sustavnom pregledu su prošireni tako da ne uključuju samo zatajenje srca koje nastaje zbog smanjenja ejekcijske frakcije (sistoličko zatajenje srca) (ejekcijska frakcija je pokazatelj koliko dobro srce radi kao crpka), nego također i zatajenje srca kod kojeg je održana ejekcijska frakcija (dijastoličko zatajenje srca). Dokazi se temelje na literaturi objavljenoj do siječnja 2013.

Ključni rezultati

Pronađena su 33 randomizirana kontrolirana pokusa koja su uključila 4740 ispitanika. Rezultati ovog obnovljenog sustavnog pregleda u skladu su s rezultatima prethodne verzije objavljene 2010. godine i pokazuju da rehabilitacija koja se temelji na tjelovježbi ima važan koristan učinak koji uključuje smanjenje broja primitaka u bolnicu zbog zatajenja srca i poboljšanja u kvaliteti života vezanoj za zdravlje u usporedbi s pacijentima koji nisu vježbali. Studije su se značajno razlikovale u rezultatima kvalitete života vezane za zdravlje. Iako se većina dokaza odnosi na rehabilitacijsku tjelovježbu u osoba sa smanjenom ejekcijskom frakcijom (sistoličko zatajenje), tijekom izrade ovog sustavnog pregleda pronađeni su dokazi koji uključuju i osobe s povećanim rizikom (NYHA stadij 4) i starije osobe te više programa koji se provode kod kuće. Nisu pronađeni dokazi koji bi pokazali da programi tjelovježbe povećavaju rizik od smrti u kratkom ili dugom roku. Pronađeno je i malen broj ekonomskih izračuna koji ukazuju da je rehabilitacijska tjelovježba isplativa. Potrebna su daljnja istraživanja koja će bolje istražiti učinak tjelovježbe na osobe s dijastoličkim zatajenjem srca te koja će istražiti isplativost rehabilitacijske tjelovježbe koja se provodi isključivo u kući pacijenta.

Kvaliteta dokaza

Nedostatci u opisu metoda istraživanja otežavali su procjenu kvalitete uključenih studija i zbog toga nije jasno postoji li mogući rizik od pristranosti.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Livia Puljak
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

Resumo para leigos

Reabilitação baseada em exercícios para insuficiência cardíaca

Introdução

As pessoas com insuficiência cardíaca têm redução marcante na sua capacidade de se exercitar, o que tem efeitos prejudiciais nas atividades do dia a dia, na qualidade de vida relacionada à saúde, na taxa de internação hospitalar e na mortalidade.

Características do estudo

Nós procuramos na literatura científica por ensaios clínicos randomizados que avaliaram a efetividade dos tratamentos baseados em exercícios versus nenhum exercício, para adultos com insuficiência cardíaca com mais de 18 anos de idade. Ensaios clínicos randomizados são experimentos com duas ou mais intervenções, com a possibilidade de incluir um grupo controle de intervenção ou nenhuma intervenção, sendo que a seleção de qual grupo recebe qual intervenção é feita de forma aleatória (ao acaso). Os critérios de inclusão para esta atualização foram ampliados. Decidimos incluir não somente a insuficiência cardíaca (IC) com fração de ejeção reduzida (ICFER ou “IC sistólica” — fração de ejeção é uma medida de quão bem o seu coração está batendo —, mas também IC com fração de ejeção preservada (ICFEP ou “IC diastólica”). A busca foi atualizada em janeiro de 2013.

Resultados principais

Nós encontramos 33 estudos clínicos randomizados que incluíram 4.740 participantes. Os achados desta atualização são consistentes com a versão prévia (2010) desta revisão Cochrane e mostram benefícios importantes da reabilitação baseada em exercícios, que incluem a redução no risco de internação devido à IC e melhoras na qualidade de vida relacionada à saúde em comparação com nenhum exercício. Houve muita variação entre os estudos para o desfecho de qualidade de vida relacionada à saúde. Enquanto a maioria das evidências mostra que a reabilitação baseada em exercício em pessoas com ICFER é benéfica, esta atualização também encontrou uma base de evidência mais ampla para essa intervenção que incluiu pacientes de alto risco (Classe IV de acordo com a New York Heart Association), pessoas idosas, pessoas com ICFEP e mais programas realizados em domicílio. Não encontramos evidência de que os programas de treinamento com exercícios sejam prejudiciais, em termos de aumento no risco de mortalidade em curto ou longo prazo. Encontramos um pequeno corpo de evidência econômica que indica que a reabilitação baseada em exercícios tem boa relação de custo-efetividade. Mais evidências são necessárias para entender melhor o efeito do treinamento com exercícios em pessoas com ICFEP e os custos e efeitos dos programas de reabilitação com exercícios exclusivamente domiciliares.

Qualidade da evidência

De uma forma geral, os estudos incluídos não apresentavam relatos detalhados dos seus métodos. Isso dificultou a avaliação da qualidade metodológica e a avaliação dos possíveis riscos de viés nesses estudos.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Maíra T. Parra).

Streszczenie prostym językiem

Stosowanie rehabilitacji opartej na ćwiczeniach fizycznych w niewydolności serca

Wprowadzenie

Osoby z niewydolnością serca doświadczają znacznego upośledzenia wydolności wysiłkowej, co ma szkodliwy wpływ na ich codzienną aktywność, jakość życia związaną ze zdrowiem, a ostatecznie również na częstość przyjęć do szpitala i umieralność.

Charakterystyka badania

Dokonano przeglądu piśmiennictwa naukowego poszukując badań z randomizacją (badań doświadczalnych, w których porównywano dwie lub większą liczbę interwencji, w tym interwencję kontrolną lub brak interwencji, przypisując uczestników losowo do badanych grup), oceniających skuteczność rehabilitacji opartej na ćwiczeniach fizycznych w porównaniu z niewykonywaniem ćwiczeń u osób u dorosłych (po 18. roku życia) z niewydolnością serca. Kryteria włączenia badań do zaktualizowanego przeglądu zostały rozszerzone, aby uwzględnić nie tylko niewydolność serca z obniżeniem frakcji wyrzutowej (HFREF lub "skurczowa niewydolność serca"), lecz także niewydolność serca z zachowaną frakcją wyrzutową (HFPEF lub "rozkurczowa niewydolność serca"). Przegląd obejmuje badania, których wyniki opublikowano do stycznia 2013 roku.

Najważniejsze wyniki

Odszukano 33 badania z randomizacją obejmujące 4740 uczestników. Wnioski z niniejszej aktualizacji są zgodne z poprzednią wersją (z 2010 roku) tego przeglądu Cochrane i wykazują ważne korzyści płynące ze stosowania rehabilitacji opartej na ćwiczeniach fizycznych, do których należą zmniejszenie ryzyka hospitalizacji z powodu niewydolności serca oraz poprawa związanej ze zdrowiem jakości życia w porównaniu z postępowaniem bez wykonywania ćwiczeń. Wyniki badań znacznie się różniły w odniesieniu do jakości życia związanej ze zdrowiem. Większość dostępnych danych dotyczyła rehabilitacji opartej na ćwiczeniach fizycznych u osób z HFREF, jednak w obecnej aktualizacji uwzględniono też więcej danych pochodzących od osób obciążonych większym ryzykiem (klasa IV w skali NYHA) i chorych w podeszłym wieku oraz osób z HFPEF, a także więcej programów rehabilitacji realizowanych w warunkach domowych. Nie było danych wskazujących, że ćwiczenia fizyczne zwiększają ryzyko śmierci w krótkiej i długiej perspektywie czasowej. Niewiele danych o charakterze ekonomicznym świadczyło, że rehabilitacja oparta na ćwiczeniach fizycznych jest opłacalna. Potrzeba więcej danych naukowych, aby lepiej ocenić wyniki ćwiczeń fizycznych u osób z HFPEF, a także koszty i efekty programów rehabilitacji z wykonywaniem ćwiczeń wyłącznie w domu.

Jakość danych naukowych

Ocenę jakości metodologicznej i analizę pod kątem potencjalnego błędu systematycznego utrudnił niedostatek szczegółowych informacji na temat metod przeprowadzenia uwzględnionych badań.

Uwagi do tłumaczenia

Tłumaczenie: Bartłomiej Matulewicz Redakcja: Ewa Płaczkiewicz-Jankowska

Summary of findings(Explanation)

Summary of findings for the main comparison. Health-related quality of life results
  1. *P values calculated by authors of this paper; +: change in outcome from baseline.

    GCHFQ: Guyatt chronic heart failure questionnaire; GH: General health; KCCQ: Kansas City Cardiomyopathy Questionnaire; MCS: mental component score; MLWHF: Minnesota Living with Heart Failure questionnaire; MOS: Medical Outcomes Study; NR: not reported; PCS: physical component score; PF: physical functioning; PGAQoL: Patient's Global Assessment of Quality of life; PGWB: Psychological General Wellbeing Index; QLI: Quality of Life Index; RL: role limitation; SF-36: 36-item Short Form.

    Exercise = Control: no statistically significant difference (P value > 0.05) in HRQoL between exercise and control groups at follow-up.

    Exercise > Control: statistically significant (P value ≤ 0.05) higher HRQoL in exercise compared to control group at follow-up.

    Exercise < Control: statistically significant (P value ≤ 0.05) lower HRQoL in exercise versus control group at follow-up.

Trial first author (year) Follow-up Measure

Outcome values (or change from baseline) at follow-up

Mean (standard deviation)

Control vs. exercise; between-group P value

Between-group difference
Austin (2005/8)

6 months

5 years

MLWHF

Physical

Emotional

Total

EQ-5D

MLWHF

Physical

Emotional

Total

EQ-5D

20.4 (12.2) vs. 12.6 (9.7); P value < 0.0001*

8.0 (7.1) vs. 4.4 (10.4); P value < 0.01*

36.9 (24.0) vs. 22.9 (17.8); P value < 0.001*

0.58 (0.19) vs. 0.70 (0.16); P value < 0.0001*

19.3 (23.5) vs. 18.3 (11.2); P value = 0.66*

7.6 (7.1) vs. 7.4 (6.5); P value = 0.88*

37.1 (24.9) vs. 35.5 (21.7); P value = 0.72*

0.58 (0.22) vs. 0.64 (0.19); P value = 0.12*

Exercise > Control

Exercise > Control

Exercise > Control

Exercise > Control

Exercise = Control

Exercise = Control

Exercise = Control

Exercise = Control

Belardinelli (1999)

15 months

29 months

MLWHF total

52 (20) vs. 39 (20); P value < 0.001

54 (22) vs. 44 (21); P value < 0.001

Exercise > Control

Exercise > Control

DANREHAB (2008)12 months

SF-36

PCS

MCS

37.4 (11.4) vs. 42.7 (9.1)*; P value = 0.14

50.5 (10.0) vs. 49.7 (8.8)*; P value = 0.81

Exercise = Control

Exercise = Control

Davidson (2010)12 monthsMLWHF total56.4 (18.3) vs. 52.9 (15.7); P value = 0.33Exercise = Control
Dracup (2007)6 months

MLWHF

Physical

Emotional

Total

19.4 (11.5) vs. 16.1 (10.0); P value = 0.04*

10.5 (7.4) vs. 7.8 (6.6); P value = 0.01*

43.2 (26.5) vs. 35.7 (23.7); P value = 0.05

Exercise > Control

Exercise > Control

Exercise > Control

Gary (2010) Comp6 monthsMLWHF total34.3 (23.6) vs. 24.2 (16.3); P value = 0.18*Exercise = Control
Gary (2010) Exer6 monthsMLWHF total28.9 (29.9) vs. 25.6 (19.7); P value = 0.71*Exercise = Control
Gottlieb (1999)6 months

MLWHF

Total

MOS

PF

RL

GH

NR (NR) vs. 22 (20) NR

-

NR (NR) vs. 68 (28) NR

NR (NR) vs. 50 (42) NR

NR (NR) vs. 361 (224) NR

NR

-

NR

NR

NR

HF-ACTION (2009)3 monthsKCCQ+5.21 (95% CI 4.42 to 6.00) vs. 3.28 (2.48 to 4.09); P value < 0.001Exercise > control
Jolly (2009)

6 months

12 months

MLWHF total

EQ-5D

MLWHF total

EQ-5D

34.5 (24.0) vs. 36.3 (24.1); P value = 0.30

0.62 (0.32) vs. 0.66 (0.24); P value = 0.004

34.9 (24.8) vs. 37.6 (21.0); P value = 0.80

0.69 (0.28) vs. 0.68 (0.21); P value = 0.07

Exercise = Control

Exercise > Control

Exercise = Control

Exercise = Control

Jónsdóttir (2006)6 monthsIcelandic Quality of Life Questionnaire4.10 (14.04) vs. 47.55 (8.7); P value = 0.34Exercise = Control
Klocek (2005)6.5 monthsPGWB total99.0 vs. 109.0 (training group A) vs. 71.7 (training group B); P value < 0.01Exercise > Control
Koukouvou (2004)6 months

MLWHF total

Spritzer QLI total

34.1 (13.0) vs. 45.1 (9.9); P value = 0.05*

7.1 (1.1) vs. 9.1 (1.1); P value < 0.0001*

Exercise > Control

Exercise > Control

McKelvie (2002)12 monthsMLWHF total+-3.3 (13.9) vs. -3.4 (18.1); P value = 0.98Exercise = Control
Nilsson (2008)12 monthsMLWHF total28 (20) vs. 22 (12); P value = 0.003Exercise > Control
Norman (2012)6 monthsKCCQ77.9 (11.6) vs. 81.0 (18.2); P value = 0.78Exercise = Control
Passino (2006)9.75 monthsMLWHF total53 (32) vs. 32 (26.5); P value < 0.0001*Exercise > Control
Willenheimer (2001)10 monthsPGAQoL0 (1) vs. 0.7 (0.9); P value = 0.023Exercise > Control
Witham (2005)6 monthsGCHFQ69 (13) vs. 65 (10); P value = 0.48Exercise = Control
Yeh (2011)12 monthsMLWHF total18 (6) vs. 13 (4); P value < 0.0001Exercise > Control

Summary of findings 2 Costs and cost-effectiveness

Summary of findings 2. Costs and cost-effectiveness
  1. CI: confidence interval; GBP: GB pounds; QALY: quality adjusted life year; SD: standard deviation; USD: US dollars.

Author (year) Georgiou (2001)

HF-ACTION

Reed (2010)

Witham (2012)

Year of costs

Country

Currency

1998

US

USD

2008

US

USD

2010

UK

GBP

Intervention cost
Mean costs/participantUSD4563USD 6482 (SD 4884)GBP474.75
Costs consideredStaffing, space rental, equipment, participant's lost wagesStaffing, participant time, travel, parkingStaffing, equipment, staff and participant travel
Cost-effectiveness
Follow-up period15.5 yearsMean 2.5 years6 months
Total mean healthcare cost/participant (exercise)USD5282*USD57,338 (SD 81,343)+GBP1888.24 (SD 3111)
Total mean healthcare costs/participant (control)USD2055*USD56,177 (SD 92,749)+GBP1943.93 (SD 4551)
Incremental healthcare costs3227*USD1161 (95% CI -6205 to 8404)GBP-447.85 (95% CI -1696.00 to 931.00)
Additional healthcare costs consideredHospitalisationsMedication, procedures, outpatient visits, emergency visits, hospitalisations, testsInpatient and outpatient admissions, primary care contacts, medication
Mean healthcare benefit (exercise)10.24 life years2.02 QALYs (SD 1.00) -
Mean healthcare benefit   (control)7.96 life years1.99 QALYS (SD 1.01) -
Incremental mean healthcare benefit1.82 life years*0.03 (95% CI -0.06 to 0.11) -
Incremental cost-effectiveness ratioUSD1773 per life year savedNot reported -

Summary of findings 3 Univariate meta-regression analysis

Summary of findings 3. Univariate meta-regression analysis
  1. *'low' risk of bias trial: absence of bias in > 5 out 8 of risk of bias items vs. 'high' risk of trial: absence of bias in < 5 out 8 items.

    HRQoL: health-related quality of life; MLWHF: Minnesota Living with Heart Failure questionnaire.

 

All-cause mortality

P value

All hospitalisations

P value

MLWHF

P value

All HRQoL outcomes

P value

Mean left ventricular ejection fraction (%)0.390.260.420.82
Mean age (years)0.290.930.090.88
Sex (% male)0.540.16 -0.69
Type of rehabilitation (exercise only vs. comprehensive)0.760.770.230.28
Type of exercise (aerobic training alone vs. aerobic plus resistance training)0.740.560.280.54
Exercise dose (number of weeks x number of sessions/week x mean duration of session in hours)0.150.800.150.28
Exercise setting I (hospital only, home only, both hospital and home)0.230.110.850.23
Exercise setting II (single centre vs. multicentre)0.940.700.140.01
Publication date0.540.540.460.60
Risk of bias*0.400.570.040.08

Summary of findings 4 Within trial subgroup analyses

Summary of findings 4. Within trial subgroup analyses
  1. ACE: angiotensin-converting enzyme; hr: hour; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEF: left ventricular ejection fraction; MET: metabolic equivalent; MI: myocardial infarction; NYHA: New York Heart Association; VO2: oxygen consumption; yr: year.

Author (year) Outcome(s) Subgroup(s) Results (P value) Data analysis methods

HF ACTION

(O'Connor, 2009)

Composite primary end point of all-cause mortality or hospitalisation, median follow-up 30 monthsAge (≤ 70 yr vs. > 70 yr), gender (males vs. females), race (white vs. non-white), heart failure aetiology (ischaemic vs. non-ischaemic), baseline LVEF (≤ 25% vs. > 25%), baseline NYHA (Class II vs. Class III/IV), previous revascularisation, history of MI, on ACE or beta-blocker at baseline

"there was no significant interaction of

exercise training with any of the factors defining these subgroups" (P value > 0.05)

 

Interaction test on hazard ratio

HF ACTION

(Flynn, 2009)

KCCQ overall score up to 36 monthsAge, LVEF (≤ 25% or > 25%), previous revascularisation (coronary artery bypass graft surgery or percutaneous coronary intervention, or no previous revascularisation), history of MI, and KCCQ overall summary score at baseline (0-50, 50-75 or 75-100)No significant subgroup interactions (P value > 0.05)Interaction test

HF ACTION

Keteyian (2012)

All-cause mortality

or hospitalisation and cardiovascular mortality or HF hospitalisation at median follow-up 28.2 months

Exercise volume defined as metabolic equivalent [MET]-hr per week

i.e. product of exercise intensity (where 1 MET is 3.5 mL VO2/ kg/min) and the hours of exercise/week

Exercise volume was logarithmic predictor (P value = 0.03) for all-cause mortality or hospitalisation. For cardiovascular mortality or heart failure hospitalisation, exercise volume was a significant (P value < 0.001) linear and logarithmic predictor

Moderate exercise volumes of 3-5 MET-hr and 5-7 MET-hr/week were associated with reductions in subsequent risk that exceeded 30%

Regression-based methods (based only on exercise group data)

Background

Description of the condition

People with heart failure (HF) present with a variety of symptoms most of which are non-specific (Watson 2000). The most frequently presenting symptom is exertional breathlessness. Other important symptoms are fatigue and lethargy in addition to swelling of the feet and ankles. There is no single diagnostic test for HF and diagnosis relies on clinical judgement based on a combination of history, physical examination and appropriate investigations. The symptoms and functional exercise capacity are used to classify the severity of HF, using the New York Heart Association (NYHA) classification (NYHA 1994), and to judge responsiveness to treatment. While diagnosis is based upon symptoms, disease severity can be quantified using objective measures, for example echocardiographic assessment of ejection fraction.

People with HF experience marked reductions in their exercise capacity, which has detrimental effects on their activities of daily living, health-related quality of life (HRQoL), and ultimately their hospital admission rate and mortality (WGCR 2001). While survival after HF diagnosis has improved (AHA 2014), HF has a poor prognosis as 30% to 40% of people diagnosed with HF die within one year although thereafter the mortality is less than 10% per year (AHA 2014). Hospital admission rates for HF in the US appear to have fallen between 1998 and 2008 (Chen 2011). However, in the UK, despite a progressive reduction in age-adjusted hospital admission rates since 1992 to 1993, admissions due HF are projected to rise by 50% over the next 25 years, largely due to the ageing of the population (NICE 2010). It is estimated that the total annual cost of HF to the UK National Health Service (NHS) is around GBP1 billion, or around 2% of the total UK NHS budget; approximately 70% of this total is due to the costs of hospitalisation (Editorial 2011; NICE 2010).

The prevalence and incidence of HF is steadily increasing, with approximately 825,000 new cases annually in the US (AHA 2014). While improved management of hypertension has reduced this condition as an aetiological factor in the development of HF, the increased survival rate from myocardial infarction has led to a subsequent increase in the number of cases of HF (Kostis 1997), as has increasing longevity in developed countries. Estimates of the prevalence of HF in the US range from 0.7% to 1.5% in adults aged 40 to 59 years; over 80 years of age the prevalence of HF is in the region of 8.6% to 11.5% (AHA 2014).

It has been increasingly recognised that HF has two subcategories. People with HF can be categorised as having impaired left ventricular contraction, which results in a reduced ejection fraction (less than 35% to 50%), known as HF with reduced ejection fraction (HFREF) or 'left ventricular dysfunction' or 'systolic HF'. The other category is HF with preserved ejection fraction (HFPEF) with an ejection fraction of greater than 35% to 50% and also known as 'diastolic HF' (Lam 2011; Owen 2006). Prognosis in HFPEF is better than HFREF. One meta-analysis reported a mortality of 32.1% in HFPEF versus 40.6% in HFREF (risk ratio (RR) 0.79) over a mean of 47 months' follow-up (Somaratne 2009). Although individuals with HFPEF are thought to contribute 54% of all people with HF, most trials to date of drug and medical device therapies have recruited only people with HFREF. This limited number of studies examining the effect of different pharmacological agents with proven use in HFREF has largely been disappointing in the HFPEF group (Holland 2011).

National and international evidence-based guidelines have been developed to help improve diagnosis and treatment for people with HF. These guidelines cover aetiology, prevention, diagnostic modalities and therapeutic interventions that increasingly include exercise rehabilitation (ACCF/AHA 2013; McMurray 2012; NICE 2010).

Description of the intervention

While there are many definitions of cardiac rehabilitation (CR), the following presents their combined key elements: "The coordinated sum of activities required to influence favourably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions, so that the patients may, by their own efforts, preserve or resume optimal functioning in their community and through improved health behaviour, slow or reverse progression of disease" (BACPR 2012). A central component of CR is exercise training (Piepoli 1998). However, in addition to exercise, programmes are encouraged also provide risk factor and lifestyle education on risk factor management plus counselling and psychological support, so-called 'comprehensive CR' (Corra 2005).

Based on current evidence of clinical outcomes and costs, national and international guidelines on the management of HF including the American College of Cardiology/American Heart Association, European Society of Cardiology and National Institute for Health and Care Excellence (NICE) in the UK consistently recommend CR as an effective and safe intervention (ACCF/AHA 2013; McMurray 2012; NICE 2010). However, these guidelines are not fully implemented in practice and the current uptake of CR for HF appears to be suboptimal (Dalal 2012; Tierney 2011). A key driver of this poor uptake has shown to be that CR programmes are not offering rehabilitation to people with HF due to lack of resources and exclusion of HF from local commissioning agreements (Dalal 2012).

How the intervention works

The precise mechanism(s) through which exercise training benefits people with HF remains unclear. One explanation, applicable to people with Ischaemic causes of HF, is that exercise training improves myocardial perfusion by alleviating endothelial dysfunction, therefore dilating coronary vessels and by stimulating new vessel formation by way of intermittent ischaemia (ExTraMatch 2004). Indeed, Belardinelli and colleagues have demonstrated that aerobic training improves myocardial contractility and diastolic filling (Belardinelli 1998). One meta-analysis by Haykowsky et al. demonstrated the benefits of exercise training on cardiac remodelling as measured by ejection fraction, end-diastolic volume and end-systolic volume (Haykowsky 2007). Regardless of cause, there are important neurohormonal and musculoskeletal abnormalities in HF. Exercise training may reduce adrenergic tone and increase vagal tone, as suggested by an assessment of variability in heart rate. Skeletal muscle dysfunction and wasting may also respond to exercise training (ExTraMatch 2004). Hambrecht et al. have demonstrated that regular physical activity in people with HF stimulates vasodilation in the skeletal muscle vasculature (Hambrecht 1998).

Why it is important to do this review

This is an update of a Cochrane review published in 2010. The first Cochrane systematic review of exercise-based interventions for HF in 2004 concluded that exercise training clearly improved short-term (up to one-year follow-up) exercise capacity compared with no exercise control (Rees 2004; Smart 2004). However, only one of the 29 included randomised controlled trials (RCTs) was powered to report hospitalisations and mortality. Few trials assessed HRQoL. Accepting the evidence for improvement in short-term exercise capacity, the updated 2010 Cochrane review focused on trials of follow-up of six-months or longer that reported clinical events (mortality, hospitalisation) or HRQoL (Davies 2010). The 2010 review of 19 RCTs (3647 participants) showed no difference between exercise and control in either short or long-term all-cause mortality, a reduction in HF-related hospitalisations (RR 0.72; 95% CI 0.52 to 0.99) and improvement in patient-reported HRQoL (standardised mean difference (SMD) 20.63; 95% CI 20.37 to 20.80) with exercise therapy. The majority of trials included in the 2010 review were in men at low-to-medium risk (NYHA class II to III). None of the trials included people with HFPEF and programmes delivered in a centre-based setting.

Using additional RCT evidence, since the 2010 Cochrane review, the aim of this update was to reassess the effectiveness of exercise-based rehabilitation on mortality, hospital admissions, morbidity and HRQoL of people with HF compared with no exercise training. In particular, we sought to identify additional evidence: 1. for those individuals poorly represented in previous reviews (i.e. older individuals, females and people with HFPEF), 2. for programmes specifically delivered in a home- or community-based setting and 3. on costs and cost-effectiveness.

Objectives

To determine the effectiveness of exercise-based rehabilitation on the mortality, hospitalisation admissions, morbidity and health-related quality of life for people with HF. Review inclusion criteria were extended to consider not only HF due to reduced ejection fraction (HFREF or 'systolic HF') but also HF due to preserved ejection fraction (HFPEF or 'diastolic HF').

Methods

Criteria for considering studies for this review

Types of studies

RCTs of either a parallel group or cross-over design where the follow-up was at least six months post-randomisation.

Types of participants

Adults aged 18 years or older with HF.

We widened the inclusion criteria to include studies with individuals with HFPEF in addition to those with HFREF who were included in the previous versions of this review. We excluded studies that included participants who had previously received exercise rehabilitation.

Types of interventions

Exercise-based interventions either alone or as a component of comprehensive CR (defined as programmes including components such as health education and psychological interventions in addition to exercise interventions). The control group must not have received exercise training but may have received active intervention (i.e. education, psychological intervention) or usual medical care alone.

Types of outcome measures

To be included the study must include one or more of the following outcomes.

Primary outcomes

Mortality and safety: all-cause mortality, deaths due to HF and sudden death.

Hospital admission or re-hospitalisation, and whether this was due to HF.

Secondary outcomes

HRQoL assessed by a validated outcome measure (e.g. 36-item Short Form (SF-36), Minnesota Living with Heart Failure (MLWHF) questionnaire), costs and cost-effectiveness.

Search methods for identification of studies

Electronic searches

For the previous reviews (Davies 2010; Rees 2004), the review authors searched the Cochrane Controlled Trials Register (Issue 1, 2001; Issue 1, 2007), MEDLINE, EMBASE and CINAHL (1984 to January 2008) (see Appendix 1; Appendix 2). The search strategy developed in 2008 included broader terms as this search was part of review strategy that sought to identify evidence for CR that included an update of this review and exercise-based rehabilitation for coronary heart disease (Heran 2011), and home- versus centre-based CR (Taylor 2010).

This search was updated from the last version (2008) and included the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2013), MEDLINE (Ovid, January 2013, week 4 2013), MEDLINE In-Process (Ovid, 5 February 2013), EMBASE (Ovid, January 2013, week 5), CINAHL (EBSCOhost, 5 February 2013) and PsycINFO (Ovid, January 2013, week 5). A small addition to the search strategy was made to reflect the more recent use of the terms 'HFPEF' and 'HFREF'.

We searched conference proceedings on Web of Science (2008 to January 2013) and trial registers (Clinicaltrials.gov; Controlled-trials.com).

We limited searches to RCTs and applied filters to limit to humans and year 2008 onwards. We imposed no language or other limitations. We considered variations in terms used and the spelling of terms in different countries, so that studies were not missed by the search strategy. We designed the search strategies with reference to those of the previous systematic review (Davies 2010), and in accordance with the Cochrane Handbook of Reviews of Interventions (Higgins 2011) (see Appendix 3).

Searching other resources

We searched reference lists of all eligible trials and identified systematic reviews for additional studies.

Data collection and analysis

Study selection

Two review authors (VAS, RST) screened the references identified by the search strategy by title and abstract and discarded clearly irrelevant studies. For selection, abstracts had to clearly identify the study design, an appropriate population and relevant components of the intervention as described above. We obtained the full-text reports of all potentially relevant trials and two review authors (VAS and RST) independently assessed them for eligibility based on the defined inclusion criteria. We resolved any disagreements by discussion. EJD, KR and RST undertook data study selection in previous review versions.

Data extraction

We extracted relevant data regarding inclusion criteria (study design; participants; interventions including type of exercise, frequency, duration, intensity and modality; comparisons and outcomes), risk of bias (randomisation, blinding, attrition and control) and results. One review author (VAS) extracted data and a second review author (RST) checked entries. We contacted study authors to seek clarification on issues of reporting or to obtain further outcome details. Excluded studies and reasons for their exclusion are detailed in the Characteristics of excluded studies table. EJD, KR and RST undertook data extraction in previous review versions.

Assessment of risk of bias in included studies

Factors considered included the quality of the random sequence generation and allocation concealment, incomplete outcome data, analysis by intention-to-treat, blinding (participants, personnel and outcome assessors) and selective outcome reporting (Higgins 2011). One review author (VAS) assessed the risk of bias in eligible trials and a second review author (RST) verified the decision. EJD, KR and RST undertook risk of bias in previous review versions.

Data analysis

We processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We expressed dichotomous outcomes as RR and 95% CI for each study. For continuous variables, we compared net changes (i.e. exercise group minus control group to give differences) and calculated mean difference (MD) or SMD and 95% CI for each study. For each trial, we sought the mean change (and standard deviation (SD)) in outcome between baseline and follow-up for both exercise and control groups and when not available, we instead used the absolute mean (and SD) outcome at follow-up for both groups. For trials with more than one relevant intervention arm, we divided the number randomised in the control group by the number of intervention arms to obtain the denominator for data analysis. Where trials reported more than one HRQoL outcome, we included the first outcome reported in the paper in the meta-analysis. We tabulated all reported HRQoL outcomes at all follow-up times for each included study. We reported outcome results at two time points: 1. up to and including 12 months' follow-up and 2. longer than 12 months' follow-up. The latest follow-up was used in each of these time point analyses.

We explored heterogeneity among included studies qualitatively (by comparing the characteristics of included studies) and quantitatively (using the Chi2 test of heterogeneity and the I2 statistic). Where appropriate, we combined the results from included studies for each outcome to give an overall estimate of treatment effect. We used a fixed-effect meta-analysis except where we identified statistical heterogeneity (I2 statistic greater than 50%), where we used a random-effects model.

We explored the potential heterogeneity in exercise-based rehabilitation by two approaches: 1. within-trial subgroup analyses (supported by subgroup x intervention/control interaction terms) and 2. between-trial analyses using meta-regression. Meta-regression was used to examine the association between the effect of exercise on all-cause mortality, all hospitalisation and HRQoL (MLWHF or other measures) up to 12 months as these three outcomes contained the most trials. Specific study covariates included in the meta-regression included: mean per cent left ventricular ejection fraction (LVEF); dose of aerobic exercise (calculated as the overall number of weeks of training multiplied by the mean number of sessions per week multiplied by the mean duration of sessions in minutes); type of exercise (aerobic training alone or aerobic plus resistance training); mean age; sex (per cent male); setting (hospital only, home only, both hospital and home); type of rehabilitation (exercise only versus comprehensive); overall risk of bias ('low', i.e. absence of bias in five or more of eight of risk of bias items; 'high', i.e. absence of bias in fewer than five of eight of risk of bias items); single versus multicentre; and publication date. We added year of publication as an additional study level factor (pre versus post 2000) in order to assess the potential effect of a change in the standard of usual care over time, that is to reflect when beta-blockers, angiotensin-receptor blockers and angiotensin-converting enzyme inhibitors became established therapies for HF (Shekelle 2003). Given the relatively small ratio of trials to covariates, meta-regression was limited to univariate analysis (Higgins 2011). The permute option in STATA was used to allow for multiple testing in meta-regression.

We used funnels plots and Egger tests to assess potential small-study effects and publication bias for those outcomes with an adequate number of trials (i.e. all-cause mortality, hospital admissions and HRQoL) (Egger 1997).

Results

Description of studies

The 2004 and 2010 versions of this Cochrane review contributed eight (Rees 2004) and 19 trials (Davies 2010) to this latest update. Several trials from the 2004 review were excluded in the 2010 review as their follow-up was less than six months or they reported only exercise capacity outcomes. This 2014 update identified a further 14 trials. The study selection process is summarised in the QUORUM flow diagram shown in Figure 1.

Figure 1.

The included 33 trials randomised 4740 participants predominantly with HFREF and NYHA classes II and III. Four trials included a (undefined) proportion of people with HFPEF (Davidson 2010; Gary 2010 (comp); Gary 2010 (exalone); Nilsson 2008; Wall 2010). The majority of trials were small (26 trials had fewer than 100 participants) and single centre (30 trials), with one large trial contributing about 50% (2331 participants) of all included participants (HF ACTION 2009). The mean age of participants across the included studies ranged from 51 to 81 years. Studies recruited predominantly men (median 87%), although there was evidence that more females were recruited in recent trials. Only four trials reported on ethnicity and 62% to 100% of the study population was white. Eleven trials reported follow-up in excess of 12 months (Austin 2005; Belardinelli 1999; Belardinelli 2012; Davidson 2010; Dracup 2007; HF ACTION 2009; McKelvie 2002; Mueller 2007; Myers 2000; Nilsson 2008; Wall 2010). Two trials had more than one exercise intervention arm. These two trials were treated as each contributing two separate comparative arms for the purpose of the meta-analysis (Gary 2010 (comp); Gary 2010 (exalone); Klocek 2005 (Const); Klocek 2005 (Prog)).

All trials evaluated an aerobic intervention and 11 also included resistance training (Austin 2005; DANREHAB 2008; Dracup 2007; Jolly 2009; Jónsdóttir 2006a; Koukouvou 2004; McKelvie 2002; Norman 2012; Pozehl 2008; Witham 2005; Witham 2012). Exercise training was most commonly delivered in either an exclusively centre-based setting or a centre-based setting in combination with some home exercise sessions. Five studies were conducted in an exclusively home-based setting (Dracup 2007; Gary 2010 (comp); Gary 2010 (exalone); Jolly 2009; Passino 2006; Wall 2010). The dose of exercise training ranged widely across studies with session duration of 15 to 120 minutes, one to seven sessions/week, intensity of 40% to 80% of maximal heart rate to 50% to 85% of maximal oxygen uptake (VO2 max) to Borg rating of 12 to 18, over a period of 15 to 120 weeks. In addition to exercise training,12 trials included other ('comprehensive rehabilitation') elements that included education and psychological interventions (Bocalini 2008; DANREHAB 2008; Davidson 2010; Gary 2010 (exalone); Jolly 2009; Jónsdóttir 2006a; Mueller 2007; Myers 2000; Nilsson 2008; Pozehl 2008; Witham 2012).

Details of the studies included in the review are shown in the Characteristics of included studies table. Reasons for exclusion are presented in the Characteristics of excluded studies table. The status of ongoing trials are detailed in the Characteristics of ongoing studies table.

Risk of bias in included studies

The overall risk of bias was moderate. A number of trials (particularly those published prior to 2000) failed to give sufficient detail to assess their potential risk of bias (Figure 2; Figure 3). Details of generation and concealment of random allocation sequence and blinding of outcomes were particularly poorly reported. Only the studies of Austin 2005; DANREHAB 2008; HF ACTION 2009; Jolly 2009; McKelvie 2002; and Witham 2012 provided an adequate description of the randomisation process. Nevertheless, none of the studies had objective evidence of imbalance in baseline characteristics. Most studies performed an intention-to-treat analysis, comparing exercise and control group outcomes according to the initial random allocation. Given the nature of an exercise intervention, is not possible to blind participants and carers. However, several studies reported blinding of outcome assessment (Davidson 2010; Gary 2010 (exalone); Gary 2010 (comp); HF ACTION 2009; McKelvie 2002, Koukouvou 2004; Nilsson 2008; Willenheimer 2001; Witham 2005; Yeh 2011). By not reporting co-intervention details for both exercise and control groups, some studies may be prone to performance bias (Belardinelli 1999; Giannuzzi 2003; Gielen 2003; Hambrecht 1995; Hambrecht 2000; Keteyian 1996; Klecha 2007; Klocek 2005 (Prog); Klocek 2005 (Const); McKelvie 2002; Nilsson 2008; Pozehl 2008). There was evidence of improvement in reporting and lower risk of bias in more recent trials.

Figure 2.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Figure 3.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Effects of interventions

See: Summary of findings for the main comparison Health-related quality of life results; Summary of findings 2 Costs and cost-effectiveness; Summary of findings 3 Univariate meta-regression analysis; Summary of findings 4 Within trial subgroup analyses

Mortality

Twenty-two studies reported all-cause mortality at up to 12-months' follow-up. The trials of Gielen 2003 and Klecha 2007 reported no deaths in either the exercise or control arm. There was no significant difference in pooled mortality up to 12 months' follow-up between groups (RR 0.93; 95% CI 0.69 to 1.27; P value = 0.59, I2 = 0%; Chi2 = 12.37, P value = 0.26, fixed-effect analysis) (Analysis 1.1). The studies of Austin 2005; Belardinelli 1999; HF ACTION 2009; Jónsdóttir 2006a; and Mueller 2007 reported mortality at 60, 26, 30, 28, and 74 months, respectively. Although not reported in their original publication (Belardinelli 2012), we obtained mortality data at 10 years by contacting the study authors. There was a trend towards a reduction in all-cause mortality when pooled across longest follow-up point of the six trials with more 12 months' follow-up (RR 0.88; 95% CI 0.75 to 1.02; P value = 0.07, I2 = 34%; Chi2 = 7.54, P value = 0.18, fixed-effect analysis) (Analysis 1.2). Studies did not consistently report deaths due to HF or sudden death.

Hospital admissions

There were reductions in the number of people experiencing hospital admissions with exercise compared with control up to 12 months' follow-up, all hospital admissions up to 12 months' follow-up (15 trials, RR 0.75; 95% CI 0.62 to 0.92; P value = 0.005, I2 = 0%; Chi2 = 11.71, P value = 0.55, fixed-effect analysis) (Analysis 1.3) and HF-specific admissions (12 trials, RR 0.61; 95% CI 0.46 to 0.80; P value = 0.002, I2 = 34%; Chi2 = 16.70, P value = 0.12) (Analysis 1.4). There was no difference in all hospital admissions in trials with more than 12 months' follow-up (5 trials, RR 0.92; 95% CI 0.66 to 1.29; P value = 0.63, I2 = 63%; Chi2 = 10.90, P value = 0.03, random-effects analysis) (Analysis 1.5)

Health-related quality of life

Nineteen out of the 33 included trials (20 comparisons) reported a validated HRQoL measure (see Summary of findings for the main comparison). The majority of studies reported disease-specific quality of life using the MLWHF, the HF ACTION 2009 trial using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Generic HRQoL was also assessed using the EuroQoL (EQ-5D), SF-36, Psychological General Wellbeing index (PGWB), Patient's Global Assessment of Quality of Life (PGAQoL) and Spritzer's Quality of Life Index (QLI). The study by Gottlieb 1999 reported HRQoL values at follow-up for the exercise group but not the controls. Eleven of the 19 trials (58%) reported superior HRQoL at follow-up in people who exercised compared with controls and in no case was HRQoL score lower with exercise than control (Summary of findings for the main comparison).

There was evidence of high levels of statistical heterogeneity in the exercise-control difference in MLWHF scores at follow-up across studies. When pooled across the 13 studies that reported the total MLWHF score up to 12 months' follow-up, there was a clinically important improvement with exercise (MD -5.8; 95% CI -9.2 to -2.4; P value = 0.0007, I2 = 70%; Chi2 = 40.24, P value < 0.0001, random-effects analysis) (Analysis 1.6). Pooling across all studies, regardless of the HRQoL measure used, there was also evidence of a significant improvement with exercise (19 trials [21 comparisons], SMD -0.46; 95% CI -0.66 to -0.26; P value < 0.0001, I2 = 80%; Chi2 = 93.86, P value < 0.0001, random-effects analysis) (Analysis 1.7). The three trials that reported MLWHF score at follow-up greater than 12 months also showed greater improvement compared with control (MD -9.5; 95% CI -17.5 to -1.5; P value < 0.0001, I2 = 73%; Chi2 = 7.33, P value < 0.02, random-effect analysis) (Analysis 1.8). Where studies reported more than one total HRQoL measure score, we selected the first cited score reported in the trial publication for meta-analysis to prevent double counting of a study; the inference of the SMD meta-analysis did not change when selecting the alternative HRQoL measure score.

Cost and cost-effectiveness

Three studies reported economic data, two undertaking a cost-effectiveness analysis (Flynn 2009; Georgiou 2001), and one reporting costs (Witham 2012) (see Summary of findings 2). Based on the Belardinelli trial (Belardinelli 1999), Georgiou and colleagues estimated an additional mean healthcare cost in the training group compared with controls of USD3227/person (Georgiou 2001). This cost was calculated by subtracting the averted hospitalisation cost, USD1336/person, from the cost of exercise training and wages lost due to exercise training, estimated at USD4563/person. Using exponential survival modelling to 15.5 years, the estimated increment in life expectancy with exercise was 1.82 years/person compared with people in the control group and an incremental cost-effectiveness ratio of USD1773/life-year saved. The HF ACTION group estimated a mean gain in QALY of 0.03 at an additional mean cost of USD1161/person at 2.5 years' follow-up (Flynn 2009). Although an incremental cost-effectiveness ratio was not reported, the authors stated that there was a 89.9% probability that exercise training was more cost-effective than usual care at a maximum willingness to pay threshold of USD50,000. Witham and colleagues reported the mean cost in the exercise group were lower (-GBP477.85/person) than the control group at six months' follow-up (Witham 2012). This cost difference was primarily the result of a reduction in the days of hospital admission in the exercise group compared with the control group. None of the between-group differences in costs or outcomes across these three studies achieved statistical significance at P value 0.05 or less level.

Meta-regression

Predictors of all-cause mortality, hospitalisation and HRQoL intervention effects (12 months or less of follow-up) were examined using univariate meta-regression. No significant associations were seen on all-cause mortality, all hospitalisation and HRQoL at the P less than 0.05 level with the exception of risk of bias and setting for HRQoL (see Summary of findings 3). The HRQoL mean effect size for studies with a higher risk of bias was larger than for studies with lower risk of bias (MLWHF MD: high risk: -14.4 vs. low risk -4.2, P value = 0.04): and higher for single-centre studies (all HRQoL SMD: single centre: -0.90 vs. multicentre -0.35, P value = 0.04).

Within-trial subgroup analyses

Several studies reported that they had undertaken subgroup analyses. However, most of these analyses were not based on a formal subgroup interaction test with the intervention effect but instead a cross-sectional association between particular participant characteristics and outcome (e.g. association between participant age at baseline and mortality (regardless of exercise or control group allocation)) (Austin 2005; Belardinelli 1999; Belardinelli 2012; Davidson 2010; Klocek 2005 (Const); Klocek 2005 (Prog)). Two studies reported subgroup analyses where the methods were unclear (Pozehl 2008; Yeh 2011). Only the large HF ACTION trial undertook a pre-defined formal interaction tests of differences in intervention effects between subgroups. The HF ACTION authors reported no evidence of difference in the intervention effects as assessed on either the primary outcome (all-cause mortality or hospitalisation) or HRQoL (KCCQ overall score) across a number of participant-defined subgroups (see Summary of findings 4). The HF ACTION group also undertook a large post hoc observational analysis in those people assigned to exercise training (Keteyian 2012). This analysis showed that the volume of exercise undertaken by participants was associated with the risk for clinical events and moderate levels (3 to 7 MET-h per week) of exercise was needed to observe a clinical benefit.

Small-study bias

There was no evidence of funnel plot asymmetry for all-cause mortality (Egger test P value = 0.805) (Figure 4) or WLWHF (Egger test P value = 0.606) (Figure 5). The funnel plots for SMD HRQoL showed evidence of asymmetry (Egger test P value < 0.0001) (Figure 6).

Figure 4.

Funnel plot of comparison: 1 All exercise interventions versus usual care, outcome: 1.1 All-cause mortality up to 12 months' follow-up.

Figure 5.

Funnel plot of comparison: 1 All exercise interventions versus usual care, outcome: 1.6 Health-related quality of life - Minnesota Living with Heart Failure (MLWHF) questionnaire up to 12 months' follow-up.

Figure 6.

Funnel plot of comparison: 1 All exercise interventions versus usual care, outcome: 1.7 Health-related quality of life - Minnesota Living with Heart Failure (MLWHF) questionnaire and other scales.

Discussion

Summary of main findings

This update review shows that, when compared with no exercise control, exercise-based rehabilitation did not significantly impact on short-term (up to 12-months' follow-up) all-cause mortality. There was trend towards a reduction in all-cause mortality in trials with follow-up in excess of 12 months. We also found a reduction in hospitalisations related due to HF and higher levels of HRQoL following exercise training programmes compared with no exercise control. It is important to note that there was significant heterogeneity in our observations on HRQoL. Univariate meta-regression analysis shows that the benefits of exercise-based rehabilitation to be independent of participant age, gender, degree of left ventricular dysfunction, type of CR (exercise only versus comprehensive), mean dose of exercise intervention, length of follow-up, overall risk of bias and trial publication date. Whilst the majority of included participants in this review were HFREF and NYHA class II to III, more recent trials have recruited those who with HFPEF and NHYA IV and a greater proportion of females and older patients. Evidence from two trials support the cost-effectiveness of exercise-based rehabilitation.

Overall completeness and applicability of evidence

The generalisability of the previous version of this review was limited as most included studies recruited only low- to moderate-risk younger men. However, with the inclusion of more women, older age and people with HFPEF in recent trials, the findings of this updated review have potential greater external validity.

Quality of the evidence

The general lack of reporting of methods in the included RCT reports made it difficult to assess their methodological quality and thereby judge their risk of bias. There was evidence of large treatment effect for HRQoL outcomes in studies judged to be overall higher risk of bias compared with lower risk of bias studies, suggesting that risk of bias may be a major driver of the substantive statistical heterogeneity seen across trials in this outcome. There appeared to be improvement in the quality of reporting in more recent trials.

Potential biases in the review process

We believe this is the most comprehensive systematic review to date of RCT-based evidence for the impact of exercise-based rehabilitation for people with HF. However, our review has some limitations. Funnel plot asymmetry for HRQoL is indicative of small-study bias and possible publication bias. Although a specific goal of this updated review was to clarify the impact of exercise training programmes on clinical events, many included trials were relatively small and of short-term follow-up so that the number of deaths and hospitalisations reported by most trials was small. Indeed, in many studies, we located event data in the trial descriptions of losses to follow-up and exclusions rather that as reported outcomes per se.

Agreement and disagreements with other studies or reviews

Based on an individual participant data pooled analysis, the ExTraMATCH Collaborative Group concluded that exercise training for HF significantly reduced overall mortality (hazard ratio 0.65; 95% CI 0.46 to 0.92) at mean follow-up of approximately two years (ExTraMatch 2004). The ExTraMATCH study was based on a limited bibliographic literature search (MEDLINE plus handsearching of selected leading cardiac journals), was limited to trials that reported survival data, and included unpublished data. Therefore, it has been difficult to verify the data and the comprehensiveness of this meta-analysis; in addition, several of the RCTs included in the Cochrane review were not included in the ExTraMATCH review. Re-analysis of the ExTraMATCH data using formal meta-analytic methods (taking account of outcome clustering at the trials level) has shown that the effect of exercise training was not statistically significant when compared with control (RR 0.88; 95% CI 0.70 to 1.10) (Gotzsche 2005).

The impact of exercise training on mortality in people with HF may depend on the length of follow-up and age of studies. While we found no improvement (or worsening) in overall survival with exercise compared with control in trials with short-term follow-up, there was a trend towards an improved survival with exercise in trials with follow-up beyond 12 months. More recent trials included in this review have been conducted in the era of optimal medical therapy. For example, at entry to the HF-ACTION trial, 94% of participants were receiving beta-blockers and angiotensin-receptor blockers or angiotensin-converting enzyme inhibitors (Whellan 2007). Forty-five per cent had an implantable cardioverter defibrillator or implanted biventricular pacemaker at the time of enrolment. Given the proven survival advantage of these medical treatments (Shekelle 2003), any incremental all-cause mortality benefit with exercise is likely to be small.

This update review found the exercise group scored on average 5.8 points higher than the control group at up 12 months' follow-up on the MLWHF questionnaire. A difference of four points or larger on the MLWHF questionnaire has been shown to represent a clinically important, meaningful difference for patients (McAlister 2004). The improvements in HRQoL seen with exercise training are in accordance with the previous systematic review of van Tol and colleagues (van Tol 2006), but not with that of Chien, which focused on home-based exercise training and concluded that exercise training compared with usual care or activity did not improve the HRQoL of people with HF (Chien 2008). Five studies included in this update review were conducted in an exclusively home-based setting (Dracup 2007; Gary 2010 (comp); Gary 2010 (exalone); Jolly 2009; Passino 2006; Wall 2010). Our meta-regression analysis showed no difference in the reduction in hospitalisations and improvement in HRQoL with exercise training between those studies based in a hospital versus home based setting.

Authors' conclusions

Implications for practice

This review shows that exercise rehabilitation provides important benefits by improving health-related quality of life and reducing heart failure (HF)-related hospitalisation in people predominantly with reduced left ventricular ejection fraction (HFREF or 'systolic HF') ranging from New York Heart Association (NYHA) class I to IV. We found no evidence to support that exercise training programmes increase (or decrease) the risk of death in the short term but there was trend towards reduced mortality in trials with follow-up beyond 12 months. The benefits of exercise training programmes appears to be independent of participant characteristics (e.g. age, gender, degree of left ventricular dysfunction) and the characteristics and setting of the exercise programmes. Programmes are typically based on aerobic exercise training with or without a resistance exercise element. Despite clinical guidelines stating their support of exercise-based rehabilitation in the management of HF, the provision and uptake of rehabilitation in HF remains poor. Future robust evidence of the economic value (costs and cost-effectiveness) of cardiac rehabilitation is likely to be important to encourage hospital and primary care providers to extend the current provision of exercise-based programmes for HF

Implications for research

The majority of trials in this review have investigated exercise training as a single intervention and against a no exercise control. However, in practice, exercise-based rehabilitation is often an adjunct to other HF management interventions, such as specialist HF nurse support or disease management programmes. While trials have demonstrated the benefits of such HF management interventions alone, few trials have compared such interventions with and without adding a structured exercise training programme (Jolly 2009; Mudge 2011). This is an important clinical question for the future design of HF services, because the addition of an exercise programme adds considerably to staffing and equipment costs. Future clinical trials of exercise rehabilitation in HF also need to consider: the generalisability of trial populations (women, older people and people with HFPEF remain under-represented in trial populations); interventions to enhance the long-term maintenance of exercise training; and outcomes, costs and cost-effectiveness of exercise-based programmes delivered exclusively in a home-based setting.

Acknowledgements

We thank for the following authors who provided additional outcome data included in this update review:

Prof Romualdo Belardinelli, Ancona, Italy (Belardinelli 2012) - mortality data.

Dr Kathryn Flynn, Department of Medicine Center for Patient Care & Outcomes Research Medical College of Wisconsin, USA (HF ACTION 2009) - health-related quality of life data.

Dr Miles Witham, University of Dundee, UK (Witham 2012) - health-related quality of life data.

Dr Ann-Dorte Zwisler, Project Manager CopenHeart, Copenhagen, Denmark (DANREHAB 2008) - mortality and health-related quality of life data for people with HF.

Data and analyses

Download statistical data

Comparison 1. All exercise interventions versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 All-cause mortality up to12 months' follow-up251871Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.69, 1.27]
2 All-cause mortality more than 12 months' follow-up62845Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.75, 1.02]
3 Hospital admission up to 12 months' follow-up151328Risk Ratio (M-H, Fixed, 95% CI)0.75 [0.62, 0.92]
4 Hospital admission heart failure only121036Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.46, 0.80]
5 Hospital admission more than 12 months' follow-up52722Risk Ratio (M-H, Random, 95% CI)0.92 [0.66, 1.29]
6 Health-related quality of life - MLWHF up to 12 months' follow-up131270Mean Difference (IV, Random, 95% CI)-5.83 [-9.21, -2.44]
7 Health-related quality of life - MLWHF and other scales213240Std. Mean Difference (IV, Random, 95% CI)-0.46 [-0.66, -0.26]
8 Health-related quality of life - MLWHF 12 months' follow-up3329Mean Difference (IV, Random, 95% CI)-9.49 [-17.48, -1.50]
Analysis 1.1.

Comparison 1 All exercise interventions versus usual care, Outcome 1 All-cause mortality up to12 months' follow-up.

Analysis 1.2.

Comparison 1 All exercise interventions versus usual care, Outcome 2 All-cause mortality more than 12 months' follow-up.

Analysis 1.3.

Comparison 1 All exercise interventions versus usual care, Outcome 3 Hospital admission up to 12 months' follow-up.

Analysis 1.4.

Comparison 1 All exercise interventions versus usual care, Outcome 4 Hospital admission heart failure only.

Analysis 1.5.

Comparison 1 All exercise interventions versus usual care, Outcome 5 Hospital admission more than 12 months' follow-up.

Analysis 1.6.

Comparison 1 All exercise interventions versus usual care, Outcome 6 Health-related quality of life - MLWHF up to 12 months' follow-up.

Analysis 1.7.

Comparison 1 All exercise interventions versus usual care, Outcome 7 Health-related quality of life - MLWHF and other scales.

Analysis 1.8.

Comparison 1 All exercise interventions versus usual care, Outcome 8 Health-related quality of life - MLWHF 12 months' follow-up.

Appendices

Appendix 1. Search strategy 2001

Cochrane Controlled Trials Register (2001, Issue 2)

1. HEART-FAILURE-CONGESTIVE*:ME
2. (HEART and FAILURE)
3. (CARDIAC and FAILURE)
4. ((#1 or #2) or #3)
5. REHABILITATION*:ME
6. EXERCISE*:ME
7. EXERCISE-THERAPY*:ME
8. SPORTS*:ME
9. PHYSICAL-EDUCATION-AND-TRAINING*:ME
10. EXERTION*:ME
11. REHABILITAT*
12. (PHYSICAL* near FIT)
13. (PHYSICAL* near FITNESS)
14. (PHYSICAL near TRAIN*)
15. (PHYSICAL* near ACTIVIT*)
16. (TRAIN* near STRENGTH*)
17. (TRAIN* near AEROBIC*)
18. (AEROBIC* near EXERCISE*)
19. KINESIOTHERAP*
20. (EXERCISE* near TRAIN*)
21. (((((((((((((((#5 or #6) or #7) or #8) or #9) or #10) or #11) or #12) or #13) or #14) or #15) or #16) or #17) or #18) or #19) or #20)
22. (#4 and #21)

Appendix 2. Search strategies 2008

CENTRAL on The Cochrane Library 2007, Issue 4

#1MeSH descriptor Myocardial Ischemia explode all trees
#2(myocard* NEAR isch*mi*)
#3isch*mi* NEAR heart
#4MeSH descriptor Coronary Artery Bypass explode all trees
#5coronary
#6MeSH descriptor Coronary Disease explode all trees
#7MeSH descriptor Myocardial Revascularization explode all trees
#8MeSH descriptor Myocardial Infarction explode all trees
#9myocard* NEAR infarct*
#10heart NEAR infarct*
#11MeSH descriptor Angina Pectoris explode all trees
#12angina
#13MeSH descriptor Heart Failure, Congestive explode all trees
#14heart and (failure or attack)
#15MeSH descriptor Heart Diseases explode all trees
#16heart and disease*
#17myocard*
#18cardiac*
#19CABG
#20PTCA
#21stent* AND (heart or cardiac*)
#22MeSH descriptor Heart Bypass, Left explode all trees
#23MeSH descriptor Heart Bypass, Right explode all trees
#24(#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR
#16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23)
#25MeSH descriptor Rehabilitation Centers, this term only
#26MeSH descriptor Exercise Therapy explode all trees
#27MeSH descriptor Sports, this term only
#28MeSH descriptor Exertion explode all trees
#29rehabilitat*
#30(physical* NEAR (fit* or train* or therap* or activit*))
#31MeSH descriptor Exercise explode all trees
#32(train*) near (strength* or aerobic or exercise*)
#33((exercise* or fitness) NEAR/3 (treatment or intervent* or program*))
#34MeSH descriptor Rehabilitation explode all trees
#35MeSH descriptor Patient Education explode all trees
#36(patient* NEAR/3 educat*)
#37((lifestyle or life-style) NEAR/3 (intervent* or program* or treatment*))
#38MeSH descriptor Self Care explode all trees
#39MeSH descriptor Ambulatory Care explode all trees
#40MeSH descriptor Psychotherapy explode all trees
#41psychotherap*
#42psycholog* NEAR intervent*
#43relax*
#44MeSH descriptor Mind-Body and Relaxation Techniques explode all trees
#45MeSH descriptor Counseling explode all trees
#46counsel*ing
#47MeSH descriptor Cognitive Therapy explode all trees
#48MeSH descriptor Behavior Therapy explode all trees
#49(behavio*r*) NEAR/4 (modif* or therap* or rehab* or change)
#50MeSH descriptor Stress, Psychological explode all trees
#51stress NEAR manage*
#52cognitive* NEAR therap*
#53MeSH descriptor Meditation explode all trees
#54meditat*
#55MeSH descriptor Anxiety, this term only
#56(manage*) NEAR (anxiety or depres*)
#57CBT
#58hypnotherap*
#59goal NEAR/3 setting
#60(psycho-educat*) or (psychoeducat*)
#61motivat* NEAR interv*
#62MeSH descriptor Psychopathology explode all trees
#63psychopathol*
#64MeSH descriptor Autogenic Training explode all trees
#65autogenic*
#66self near (manage* or care or motivat*)
#67distress*
#68psychosocial* or psycho-social
#69MeSH descriptor Health Education explode all trees
#70(nutrition or diet or health) NEAR education
#71heart manual
#72(#25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 OR #34 OR #35 OR #36 OR #37)
#73(#38 OR #39 OR #40 OR #41 OR #42 OR #43 OR #44 OR #45 OR #46 OR #47 OR #48 OR #49 OR #50 OR
#51 OR #52 OR #53 OR #54 OR #55 OR #56 OR #57 OR #58 OR #59 OR #60 OR #61 OR #62 OR #63 OR #64 OR
#65 OR #66 OR #67 OR #68 OR #69 OR #70 OR #71)
#74(#72 OR #73)
#75(#74 AND #24)

MEDLINE DIALOG to WEEK 1 2008

1. SEARCH: MYOCARDIAL-ISCHEMIA#.DE.
2. SEARCH: MYOCARD$4 NEAR (ISCHAEMI$2 OR ISCHEMI$2)
3. SEARCH: (ISCHAEMI$2 OR ISCHEMI$2) NEAR HEART
4. SEARCH: CORONARY-ARTERY-BYPASS#.DE.
5. SEARCH: CORONARY.TI,AB.
6. SEARCH: CORONARY-DISEASE#.DE.
7. SEARCH: MYOCARDIAL-REVASCULARIZATION#.DE.
8. SEARCH: MYOCARDIAL-INFARCTION#.DE.
9. SEARCH: MYOCARD$5 NEAR INFARCT$5
10. SEARCH: HEART NEAR INFARCT$5
11. SEARCH: ANGINA-PECTORIS#.DE.
12. SEARCH: ANGINA.TI,AB.
13. SEARCH: HEART-FAILURE-CONGESTIVE#.DE.
14. SEARCH: HEART NEAR FAILURE
15. SEARCH: 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14
16. SEARCH: HEART-DISEASES#.DE.
17. SEARCH: (HEART NEAR DISEASE$2).TI,AB.
18. SEARCH: MYOCARD$5.TI,AB.
19. SEARCH: CARDIAC$2.TI,AB.
20. SEARCH: CABG
21. SEARCH: PTCA
22. SEARCH: STENT$4 AND (HEART OR CARDIAC$4)
23. SEARCH: HEART-BYPASS-LEFT#.DE. OR HEART-BYPASS-RIGHT#.DE.
24. SEARCH: 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22 OR 23
25. SEARCH: REHABILITATION-CENTERS.DE.
26. SEARCH: EXERCISE-THERAPY#.DE.
27. SEARCH: REHABILITATION.W..DE.
28. SEARCH: SPORTS#.W..DE.
29. SEARCH: EXERTION#.W..DE.
30. SEARCH: EXERCISE#.W..DE.
31. SEARCH: REHABILITAT$5.TI,AB.
32. SEARCH: PHYSICAL$4 NEAR (FIT OR FITNESS OR TRAIN$5 OR THERAP$5 OR ACTIVIT$5)
33. SEARCH: TRAIN$5 NEAR (STRENGTH$3 OR AEROBIC OR EXERCIS$4)
34. SEARCH: (EXERCISE$4 OR FITNESS) NEAR (TREATMENT OR INTERVENT$4 OR PROGRAM$2 OR THERAPY)
35. SEARCH: PATIENT-EDUCATION#.DE.
36. SEARCH: PATIENT$2 NEAR EDUCAT$4
37. SEARCH: (LIFESTYLE OR LIFE-STYLE) NEAR (INTERVENT$5 OR PROGRAM$2 OR TREATMENT$2)
38. SEARCH: SELF-CARE.DE.
39. SEARCH: SELF NEAR (MANAGE$5 OR CARE OR MOTIVAT$5)
40. SEARCH: AMBULATORY-CARE.DE.
41. SEARCH: PSYCHOTHERAPY#.W..DE.
42. SEARCH: PSYCHOTHERAP$2.TI,AB.
43. SEARCH: PSYCHOLOG$5 NEAR INTERVENT$5
44. SEARCH: RELAX$6.TI,AB.
45. SEARCH: RELAXATION-TECHNIQUES#.DE. OR MIND-BODY-AND-RELAXATION-TECHNIQUES#.DE.
46. SEARCH: COUNSELING#.W..DE.
47. SEARCH: (COUNSELLING OR COUNSELING).TI,AB.
48. SEARCH: COGNITIVE-THERAPY#.DE.
49. SEARCH: BEHAVIOR-THERAPY#.DE.
50. SEARCH: (BEHAVIOR$4 OR BEHAVIOUR$4) NEAR (MODIFY OR MODIFICAT$4 OR THERAP$2 OR CHANGE)
51. SEARCH: STRESS-PSYCHOLOGICAL#.DE.
52. SEARCH: STRESS NEAR MANAGEMENT
53. SEARCH: COGNITIVE NEAR THERAP$2
54. SEARCH: MEDITAT$4
55. SEARCH: MEDITATION#.W..DE.
56. SEARCH: ANXIETY#.W..DE.
57. SEARCH: MANAGE$5 NEAR (ANXIETY OR DEPRES$5)
58. SEARCH: CBT.TI,AB.
59. SEARCH: HYPNOTHERAP$5
60. SEARCH: GOAL NEAR SETTING
61. SEARCH: GOAL$2 NEAR SETTING
62. SEARCH: PSYCHO-EDUCAT$5 OR PSYCHOEDUCAT$5
63. SEARCH: MOTIVAT$5 NEAR (INTERVENTION OR INTERV$3)
64. SEARCH: PSYCHOPATHOLOGY#.W..DE.
65. SEARCH: PSYCHOPATHOL$4.TI,AB.
66. SEARCH: PSYCHOSOCIAL$4.TI,AB.
67. SEARCH: DISTRESS$4.TI,AB.
68. SEARCH: HEALTH-EDUCATION#.DE.
69. SEARCH: HEALTH NEAR EDUCATION
70. SEARCH: HEART ADJ MANUAL
71. SEARCH: AUTOGENIC-TRAINING#.DE.
72. SEARCH: AUTOGENIC$5.TI.AB.
73. SEARCH: 25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32 OR 33 OR 34 OR 35 OR 36 OR 37 OR 38
74. SEARCH: 39 OR 40 OR 41 OR 42 OR 43 OR 44 OR 45 OR 46 OR 47 OR 48 OR 49 OR 50 OR 51 OR 52 OR 53
OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60 OR 61 OR 62 OR 63 OR 64 OR 65 OR 66 OR 67 OR 68 OR 69 OR
70 OR 71 OR 72
75. SEARCH: 15 OR 24
76. SEARCH: 73 or 74
77. SEARCH: 75 AND 76
78. SEARCH: RANDOMIZED-CONTROLLED-TRIALS#.DE.
79. SEARCH: PT=RANDOMIZED-CONTROLLED-TRIAL
80. SEARCH: PT=CONTROLLED-CLINICAL-TRIAL
81. SEARCH: CONTROLLED-CLINICAL-TRIALS#.DE.
82. SEARCH: RANDOM-ALLOCATION#.DE.
83. SEARCH: DOUBLE-BLIND-METHOD#.DE.
84. SEARCH: SINGLE-BLIND-METHOD#.DE.
85. SEARCH: (RANDOM$ OR PLACEBO$).TI,AB.
86. SEARCH: ((SINGL$3 OR DOUBL$3 OR TRIPL$3 OR TREBL$3) NEAR (BLIND$3 OR MASK$3)).TI,AB.
87. SEARCH: RESEARCH-DESIGN#.DE.
88. SEARCH: PT=CLINICAL-TRIAL#
89. SEARCH: CLINICAL-TRIALS#.DE.
90. SEARCH: (CLINIC$3 ADJ TRIAL$2).TI,AB.
91. SEARCH: 77 AND 90
92. SEARCH: (ANIMALS NOT HUMANS).SH.
93. SEARCH: 91 NOT 92
94. SEARCH: LIMIT 93 TO 2001-DATE

EMBASE DIALOG to WEEK 1 2008

1. HEART-DISEASE#.DE.
2. (MYOCARD$4 NEAR (ISCHAEMI$2 OR ISCHEMI$2)).TI,AB.
3. ((ISCHAEMI$2 OR ISCHEMI$2) NEAR HEART).TI,AB.
4. CORONARY-ARTERY-DISEASE#.DE.
5. TRANSLUMINAL-CORONARY-ANGIOPLASTY#.DE.
6. (CORONARY NEAR (DISEASE$2 OR BYPASS$2 OR THROMBO$5 OR ANGIOPLAST$2)).TI,AB.
7. HEART-INFARCTION#.DE.
8. (MYOCARD$4 NEAR INFARCT$5).TI,AB.
9. (HEART NEAR INFARC$5).TI,AB.
10. HEART-MUSCLE-REVASCULARIZATION#.DE.
11. ANGINA-PECTORIS#.DE.
12. ANGINA.TI,AB.
13. CONGESTIVE-HEART-FAILURE#.DE.
14. (HEART NEAR FAILURE).TI,AB.
15. 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14
16. (HEART NEAR DISEASE$2).TI,AB.
17. CARDIAC$2.TI,AB.
18. CABG.TI,AB.
19. PTCA.TI,AB.
20. STENT$4.TI,AB. AND HEART.TI,AB.
21. EXTRACORPOREAL-CIRCULATION#.DE.
22. 16 OR 17 OR 18 OR 19 OR 20 OR 21
23. 15 OR 22
24. PSYCHOTHERAPY#.W..DE.
25. PSYCHOTHERAP$2.TI,AB.
26. PSYCHOLOG$5 NEAR INTERVENT$5
27. RELAX$6.TI,AB.
28. RELAXATION-TRAINING#.DE.
29. COUNSELING#.W..DE.
30. (COUNSELLING OR COUNSELING).TI,AB.
31. (BEHAVIOR$4 OR BEHAVIOUR$4) NEAR (MODIFY OR MODIFICAT$4 OR THERAPY$2 OR CHANGE)
32. STRESS-MANAGEMENT#.DE.
33. STRESS NEAR MANAGEMENT
34. MEDITATION#.W..DE.
35. MEDITAT$5.TI,AB.
36. MANAGE$5 NEAR (ANXIETY OR DEPRES$5)
37. CBT.TI,AB.
38. HYPNOTHERAP$2.TI,AB.
39. GOAL$2 NEAR SETTING
40. PSYCHO-EDUCAT$5 OR PSYCHOEDUCAT$5
41. MOTIVAT$5 NEAR INTERVENT$6
42. PSYCHOSOCIAL-CARE#.DE. OR PSYCHOSOCIAL-REHABILITATION#.DE.
43. PSYCHOSOCIAL.TI,AB.
44. HEALTH-EDUCATION#.DE.
45. HEALTH NEAR EDUCATION
46. HEART ADJ MANUAL
47. AUTOGENIC-TRAINING#.DE.
48. AUTOGENIC.TI,AB.
49. REHABILITATION#.W..DE.
50. REHABILITATION-CENTER#.DE.
51. REHABIL$.TI,AB.
52. SPORT#.W..DE.
53. KINESIOTHERAPY#.W..DE.
54. EXERCISE#.W..DE.
55. PHYSIOTHERAPY#.W..DE.
56. PHYSICAL$4 NEAR (FIT OR FITNESS OR TRAIN$5 OR THERAP$5 OR ACTIVIT$5)
57. TRAIN$5 NEAR (STRENGTH$3 OR AEROBIC OR EXERCIS$4)
58. (EXERCISE$4 OR FITNESS) NEAR (TREATMENT OR INTERVENT$4 OR PROGRAM$2 OR THERAPY)
59. AEROBIC$4 NEAR EXERCISE$4
60. (KINESIOTHERAPY OR PHYSIOTHERAPY).TI,AB.
61. PATIENT-EDUCATION#.DE.
62. PATIENT$2 NEAR EDUCAT$4
63. (LIFESTYLE OR LIFE ADJ STYLE OR LIFE-STYLE) NEAR (INTERVENT$5 OR PROGRAM$2 OR TREATMENT$2)
64. SELF-CARE#.DE.
65. SELF NEAR (MANAGE$5 OR CARE OR MOTIVAT$5)
66. AMBULATORY-CARE#.DE.
67. PSYCHO-EDUCAT$5 OR PSYCHOEDUCAT$5
68. MOTIVAT$5 NEAR INTERVENT$6
69. PSYCHOSOCIAL-CARE#.DE. OR PSYCHOSOCIAL-REHABILITATION#.DE.
70. PSYCHOSOCIAL.TI,AB.
71. HEALTH-EDUCATION#.DE.
72. HEALTH NEAR EDUCATION
73. HEART ADJ MANUAL
74. AUTOGENIC-TRAINING#.DE.
75. AUTOGENIC.TI,AB.
76. PSYCHO-EDUCAT$5 OR PSYCHOEDUCAT$5
77. MOTIVAT$5 NEAR INTERVENT$6
78. PSYCHOSOCIAL-CARE#.DE. OR PSYCHOSOCIAL-REHABILITATION#.DE.
79. PSYCHOSOCIAL.TI,AB.
80. HEALTH-EDUCATION#.DE.
81. HEALTH NEAR EDUCATION
82. HEART ADJ MANUAL
83. 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or
42 or 43 or 44 or 45 or 46 or 47 or 48 or 49
84 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60 OR 61 OR 62 OR 63 OR 64 OR 65 OR
66 OR 67 OR 68 OR 69 OR 70 OR 71 OR 72 OR 73 OR 74 OR 75 OR 76 OR 77 OR 78 OR 79 OR 80 OR 81 OR 82
85. 83 OR 84
86. (RANDOM$ OR PLACEBO$).TI,AB.
87. (SINGL$4 OR DOUBLE$4 OR TRIPLE$4 OR TREBLE$4).TI,AB. AND (BLIND$4 OR MASK$4).TI,AB.
88. (CONTROLLED ADJ CLINICAL ADJ TRIAL).TI,AB.
89. RANDOMIZED-CONTROLLED-TRIAL#.DE.
90. 1 OR 2 OR 3 OR 4
91. 23 AND 85
92. 91 AND 92
93. LIMIT 92 TO 2001-2008

CINAHL DIALOG to WEEK 1 2008

1. ((MYOCARD$4 OR HEART) NEAR (ISCHAEMI$2 OR ISCHEMI$2)).TI,AB.
2. CORONARY.TI,AB.
3. ((MYOCARD$4 OR HEART) NEAR INFARC$5).TI,AB.
4. ANGINA.TI,AB.
5. (HEART NEAR FAILURE).TI,AB.
6. (HEART NEAR DISEAS$2).TI,AB.
7. CARDIAC$2.TI,AB.
8. CABG
9. PTCA
10. STENT$4.TI,AB. AND (HEART OR CARDIAC$4).TI,AB.
11. MYOCARDIAL-ISCHEMIA#.DE.
12. MYOCARDIAL-INFARCTION#.DE.
13. CORONARY-ARTERY-BYPASS#.DE.
14. CORONARY-DISEASE#.DE.
15. CARDIAC-PATIENTS#.DE.
16. MYOCARDIAL-DISEASES#.DE.
17. MYOCARDIAL-REVASCULARIZATION#.DE.
18. HEART-DISEASES#.DE.
19. CARDIOVASCULAR-DISEASES#.DE.
20. HEART-FAILURE-CONGESTIVE#.DE.
21. ANGINA-PECTORIS#.DE.
22. 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18
OR 19 OR 20 OR 21
23. REHABILITATION#.W..DE.
24. SPORTS#.W..DE.
25. EXERCISE#.W..DE.
26. PHYSICAL-ACTIVITY#.DE.
27. MUSCLE-STRENGTHENING#.DE.
28. AEROBIC-EXERCISES#.DE.
29. PHYSICAL-FITNESS#.DE.
30. PATIENT-EDUCATION#.DE.
31. THERAPEUTIC-EXERCISE#.DE.
32. REHABILITAT$5.TI,AB.
33. (PHYSICAL$4 NEAR (FIT OR FITNESS OR TRAIN$4 OR THERAP$5 OR ACTIVIT$4)).TI,AB.
34. (TRAIN$4 NEAR (STRENGTH$3 OR AEROBIC OR EXERCIS$4)).TI,AB.
35. ((EXERCISE$4 OR FITNESS) NEAR (TREATMENT OR INTERVENT$4 OR PROGRAM$2 OR THERAPY)).TI,AB.
36. (PATIENT$2 NEAR EDUCAT$4).TI,AB.
37. ((LIFESTYLE OR LIFE-STYLE) NEAR (INTERVENT$5 OR PROGRAM$2 OR TREATMENT$2)).TI,AB.
38. SELF-CARE#.DE.
39. (SELF NEAR (MANAGE$5 OR CARE OR MOTIVAT$5)).TI,AB.
40. AMBULATORY-CARE#.DE.
41 AEROBIC.TI,AB.
42. RESISTANCE ADJ TRAIN$4
43. MUSCLE ADJ STRENGTH$5
44. AEROBIC.TI,AB.
45. RESISTANCE ADJ TRAIN$4
46. MUSCLE ADJ STRENGTH$5
47. PSYCHOTHERAPY#.W..DE.
48. PSYCHOTHERAP$2.TI,AB.
49. (PSYCHOLOG$5 NEAR INTERVENT$5).TI,AB.
50. RELAX.TI,AB.
51. RELAXATION-TECHNIQUES#.DE.
52. (COUNSELLING OR COUNSELING).TI,AB.
53. COUNSELING#.W..DE.
54. ((BEHAVIOR$4 OR BEHAVIOUR$4) NEAR (MODIFY OR MODIFICAT$4 OR THERAP$2 OR CHANGE)).TI,AB.
55. STRESS-MANAGEMENT#.DE.
56. (STRESS NEAR MANAG$5).TI,AB.
57. (COGNITIVE NEAR THERAP$2).TI,AB.
58. MEDITATION#.W..DE.
59. MEDITAT$5.TI,AB.
60. ANXIETY#.W..DE.
61. (MANAGE$5 NEAR (ANXIETY OR DEPRESS$5)).TI,AB.
62. CBT.TI,AB.
63. HYPNOTHERAP$5.TI,AB.
64. (GOAL$2 NEAR SETTING).TI,AB.
65. (PSYCHO-EDUCAT$5 OR PSYCHOEDUCAT$5).TI,AB.
66. (MOTIVAT$5 NEAR (INTERV$3 OR INTERVENT$5)).TI,AB.
67. PSYCHOSOCIAL$4.TI,AB.
68. HEALTH-EDUCATION#.DE.
69. (HEALTH NEAR EDUCAT$5).TI,AB.
70. HEART ADJ MANUAL
71. AUTOGENIC$3.TI,AB.
72. 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32 OR 33 OR 34 OR 35 OR 36 OR 37 OR 38 OR
39 OR 40 OR 41 OR 42 OR 43 OR 44 OR 45 OR 46
73. 47 OR 48 OR 49 OR 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60 OR 61 OR 62 OR
63 OR 64 OR 65 OR 66 OR 67 OR 68 OR 69 OR 70 OR 71
74. 72 OR 73
75. 22 AND 74
76. PT=CLINICAL-TRIAL
77. CLINICAL-TRIALS#.DE.
78. (RANDOM$5 OR PLACEBO$2).TI,AB.
79. (SINGL$ OR DOUBLE$ OR TRIPLE$ OR TREBLE$).TI,AB. AND (BLIND$ OR MASK$).TI,AB.
80. CONTROLLED ADJ CLINICAL ADJ TRIALS
81. 76 OR 77 OR 78 OR 79 OR 80
82. 75 AND 81
83. LIMIT 82 TO 2001-2008

PsycINFO DIALOG TO JAN WEEK 1

1. SEARCH: HEART-DISORDERS#.DE.
2. SEARCH: MYOCARDIAL-INFARCTIONS.DE.
3. SEARCH: ISCHEMIA#.W..DE.
4. SEARCH: HEART-SURGERY.DE.
5. SEARCH: ANGIOPLASTY
6. SEARCH: HEART ADJ BYPASS
7. SEARCH: CORONARY.TI,AB.
8. SEARCH: (ISCHEMI$3 OR ISCHAEMI$3).TI,AB.
9. SEARCH: (MYOCARD$5 NEAR INFARCT$5).TI,AB.
10. SEARCH: (HEART NEAR (INFARC$5 OR FAILURE OR ATTACK)).TI,AB.
11. SEARCH: ANGINA.TI,AB.
12. SEARCH: (HEART NEAR DISEASE$2).TI,AB.
13. SEARCH: MYOCARD$5.TI,AB.
14. SEARCH: CARDIAC$4.TI,AB.
15. SEARCH: CABG.TI,AB.
16. SEARCH: PTCA.TI,AB.
17. SEARCH: 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16
18. SEARCH: PHYSICAL-ACTIVITY#.DE.
19. SEARCH: SPORTS#.W..DE.
20. SEARCH: PHYSICAL-EDUCATION.DE.
21. SEARCH: HEALTH-BEHAVIOR#.DE.
22. SEARCH: PHYSICAL-FITNESS.DE.
23. SEARCH: (PHYSICAL ADJ EDUCATION).TI,AB.
24 SEARCH: EXERTION.TI,AB.
25. SEARCH: REHABILITAT$6.TI,AB.
26. SEARCH: (PHYSICAL NEAR (FIT$5 OR TRAIN$5 OR THERAP$5 OR ACTIVIT$4)).TI,AB.
27. SEARCH: (TRAIN$4 NEAR (STRENGTH$4 OR AEROBIC OR EXERCISE$2)).TI,AB.
28. SEARCH: ((EXERCISE$3 OR FITNESS) NEAR (TREATMENT OR INTERVENT$4 OR PROGRAM$4 OR
THERAP$2)).TI,AB.
29. SEARCH: (PATIENT WITH EDUCATION).TI,AB.
30. SEARCH: CLIENT-EDUCATION#.DE.
31. SEARCH: HEALTH-PROMOTION#.DE.
32. SEARCH: ((LIFESTYLE OR LIFE-STYLE) NEAR (INTERVENT$5 OR PROGRAM$2 OR TREATMENT$2)).TI,AB.
33. SEARCH: OUTPATIENT-TREATMENT#.DE.
34. SEARCH: 18 OR 19 OR 20 OR 21 OR 22 OR 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32
OR 33
35. SEARCH: PSYCHOTHERAPY#.W..DE.
36 SEARCH: PSYCHOTHERAP$2.TI,AB.
37 SEARCH: TREATMENT#.W..DE.
38 SEARCH: (PSYCHOLOG$4 NEAR INTERVENT$5).TI,AB.
39 SEARCH: COUNSELING#.W..DE.
40 SEARCH: COPING-BEHAVIOR#.DE.
41 SEARCH: MEDITATION.W..DE.
42 SEARCH: AUTOGENIC-TRAINING.DE.
43 SEARCH: HEALTH-EDUCATION#.DE.
44. SEARCH: RELAX$6.TI,AB.
45. SEARCH: (COUNSELLING OR COUNSELING).TI,AB.
46. SEARCH: ((BEHAVIOUR OR BEHAVIOR) NEAR (MODIF$5 OR THERAP$5 OR REHABILIT$5 OR CHANGE)).TI,AB.
47. SEARCH: (STRESS NEAR MANAGE$5).TI,AB.
48. SEARCH: MEDITAT$5.TI,AB.
49. SEARCH: (MANAGE$5 NEAR (ANXIETY OR DEPRES$5)).TI,AB.
50. SEARCH: (CBT OR COGNITIV$2 NEAR THERAP$3).TI,AB.
51. SEARCH: HYPNOTHERAP$3.TI,AB.
52. SEARCH: (PSYCHO-EDUCAT$6 OR PSYCHOEDUCAT$6).TI,AB.
53. SEARCH: (MOTIVAT$5 NEAR INTERVENT$5).TI,AB.
54. SEARCH: (SELF NEAR MANAG$6).TI,AB.
55. SEARCH: AUTOGENIC$3.TI,AB.
56. SEARCH: (GOAL NEAR SETTING).TI,AB.
57. SEARCH: (HEALTH NEAR EDUCATION).TI,AB.
58. SEARCH: (HEART ADJ MANUAL).TI,AB.
59. SEARCH: 35 OR 36 OR 37 OR 38 OR 39 OR 40 OR 41 OR 42 OR 43 OR 44 OR 45 OR 46 OR 47 OR 48 OR 49
OR 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58
60. SEARCH: 17 AND (34 OR 59)
61. SEARCH: (RANDOM$5 OR PLACEBO$5).TI,AB.
62. SEARCH: (DOUBLE$4 OR SINGLE$4 OR TRIPLE$4).TI,AB. AND (BLIND$4 OR MASK OR SHAM$4 OR
DUMMY).TI,AB.
63. SEARCH: RCT.TI,AB.
64. SEARCH: AT=TREATMENT$
65. SEARCH: 61 OR 62 OR 63 OR 64
66. SEARCH: 60 AND 66
67. SEARCH: LIMIT 66 TO YRS=2001-2008

ISI Proceedings, search date 1 April 2008

 # 7 807 #5 and #6
Databases=STP Timespan=2001-2008
# 6 29,517 TS=(rehab* or educat*)
Databases=STP Timespan=2001-2008
# 5 52,687 #4 OR #3 OR #2 OR #1
Databases=STP Timespan=2001-2008
# 4 27,506 TS=(angina or cardiac* or PTCA or CABG)
Databases=STP Timespan=2001-2008
# 3 11,226 TS=((heart) SAME (infarct* or isch?emia or failure or attack))
Databases=STP Timespan=2001-2008
# 2 12,618 TS=((coronary* or heart*) SAME (by?pass or disease*))
Databases=STP Timespan=2001-2008
# 1 11,809 TS=((myocard*) SAME (isch?emia or infarct* or revasculari?*))
Databases=STP Timespan=2001-2008

Appendix 3. Search strategies 2013

CENTRAL on The Cochrane Library 2013, Issue 1

1.    MeSH descriptor: [Myocardial Ischemia] explode all trees

2.    (myocard* near isch*mi*):ti or (myocard* near isch*mi*):ab

3.    (isch*mi* near heart):ti or (isch*mi* near heart):ab

4.    MeSH descriptor: [Coronary Artery Bypass] explode all trees

5.    (coronary):ti or (coronary):ab

6.    MeSH descriptor: [Coronary Disease] explode all trees

7.    MeSH descriptor: [Myocardial Revascularization] explode all trees

8.    MeSH descriptor: [Myocardial Infarction] explode all trees

9.   (myocard* near infarct*):ti or (myocard* near infarct*):ab

10. (heart near infarct*):ti or (heart near infarct*):ab

11. MeSH descriptor: [Angina Pectoris] explode all trees

12. (angina):ti or (angina):ab

13. MeSH descriptor: [Heart Failure] explode all trees

14. (heart and (failure or attack)):ti or (heart and (failure or attack)):ab

15. (Heart diseases):ti or (Heart diseases):ab

16. MeSH descriptor: [Heart Diseases] explode all trees         

17. (heart and (disease*)):ti or (heart and (disease*)):ab         

18. (myocard*):ti or (myocard*):ab            

19. (cardiac*):ti or (cardiac*):ab     

20. (CABG):ti or (CABG):ab           

21. (PTCA):ti or (PTCA):ab            

22. (stent* and (heart or cardiac*)):ti or (stent* and (heart or cardiac*)):ab    

23. MeSH descriptor: [Heart Bypass, Left] explode all trees    

24. (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF"):ti or (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF"):ab           

25. (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24)

26. MeSH descriptor: [Rehabilitation Centers] this term only

27. MeSH descriptor: [Exercise Therapy] explode all trees     

28. MeSH descriptor: [Sports] this term only      

29. MeSH descriptor: [Physical Exertion] explode all trees     

30. (rehabilitat*):ti or (rehabilitat*):ab       

31. (physical* near (fit* or train* or therap* or activit*)):ti or (physical* near (fit* or train* or therap* or activit*)):ab         

32. MeSH descriptor: [Exercise] explode all trees         

33. (train*) near (strength* or aerobic or exercise*):ti or (train*) near (strength* or aerobic or exercise*):ab      

34. ((exercise* or fitness) near/3 (treatment or intervent* or program*)):ti or ((exercise* or fitness) near/3 (treatment or intervent* or program*)):ab      

35. MeSH descriptor: [Rehabilitation] explode all trees           

36. MeSH descriptor: [Patient Education as Topic] this term only      

37. (patient* near/3 educat*):ti or (patient* near/3 educat*):ab            

38. ((lifestyle or life-style) near/3 (intervent* or program* or treatment*)):ti or ((lifestyle or life-style) near/3 (intervent* or program* or treatment*)):ab     

39. MeSH descriptor: [Self Care] explode all trees        

40. MeSH descriptor: [Ambulatory Care] explode all trees      

41. MeSH descriptor: [Psychotherapy] explode all trees          

42. (psychotherap*):ti or (psychotherap*):ab

43. (psycholog* near intervent*):ti or (psycholog* near intervent*):ab

44. (relax*):ti or (relax*):ab

45. MeSH descriptor: [Mind-Body Therapies] explode all trees

46. ((Mind or Body) and (Relaxation Techniques)):ti or ((Mind or Body) and (Relaxation Techniques)):ab      

47. MeSH descriptor: [Counseling] explode all trees   

48. (counseling or counselling):ti or (counseling or counselling):ab            

49. MeSH descriptor: [Cognitive Therapy] explode all trees    

50. MeSH descriptor: [Behavior Therapy] explode all trees     

51. ((behavio*r*) near/4 (modif* or therap* or rehab* or change)):ti or ((behavio*r*) near/4 (modif* or therap* or rehab* or change)):ab       

52. MeSH descriptor: [Stress, Psychological] explode all trees          

53. (stress near manage*):ti or (stress near manage*):ab

54. (cognitive* near therap*):ti or (cognitive* near therap*):ab

55. MeSH descriptor: [Meditation] explode all trees      

56. (meditat*):ti or (meditat*):ab     

57. MeSH descriptor: [Anxiety] this term only

58. ((manage*) near (anxiety or depres*)):ti or ((manage*) near (anxiety or depres*)):ab

59. (CBT):ti or (CBT):ab

60. (hypnotherap*):ti or (hypnotherap*):ab

61. (goal near/3 (setting)):ti or (goal near/3 (setting)):ab

62. ((psycho-educat*) or (psychoeducat*)):ti ((psycho-educat*) or (psychoeducat*)):ab

63. (motivat* near (interv*)):ti or (motivat* near (interv*)):ab

64. MeSH descriptor: [Psychopathology] explode all trees     

65. (psychopathol*):ti or (psychopathol*):ab

66. MeSH descriptor: [Autogenic Training] explode all trees  

67. (autogenic*):ti or (autogenic*):ab

68. (self near (manage* or care or motivat*)):ti or (self near (manage* or care or motivat*)):ab

69. (distress*):ti or (distress*):ab   

70. (psychosocial* or psycho-social):ti or (psychosocial* or psycho-social):ab

71. MeSH descriptor: [Health Education] explode all trees

72. (nutrition or diet or health near (education)):ti or (nutrition or diet or health near (education)):ab    

73. (heart manual):ti or (heart manual):ab

74. (#26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37)

75. (#38 or #40 or #41 or #42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52 or #53 or #54 or #55 or #56 or #57 or #58 or #59 or #60 or #61 or #62 or #63 or #64 or #65 or #66 or #67 or #68 or #69 or #70 or #71 or #72 or #73)

76. (#74 or #75)

77. (#76 and #25)

78. #77 from 2008, in Trials

 

MEDLINE(R) Ovid 1946 to January week 4 2013

1.    exp Myocardial Ischemia/

2.    (myocard$4 adj5 (ischaemi$2 or ischemi$2)).ti,ab.

3.    ((ischaemi$2 or ischemi$2) adj5 heart).ti,ab.

4.    exp Coronary Artery Bypass/

5.    coronary.ti,ab.

6.    exp Coronary Disease/

7.    exp Myocardial Revascularization/

8.    Myocardial Infarction/

9.    (myocard$5 adj5 infarct$5).ti,ab.

10. (heart adj5 infarct$5).ti,ab.

11. exp Angina Pectoris/

12. angina.ti,ab.

13. exp Heart Failure/

14. (heart adj5 failure).ti,ab.

15. (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF").ti,ab.

16. or/1-15

17. exp Heart Diseases/

18. (heart adj5 disease$2).ti,ab.

19. myocard$5.ti,ab.

20. cardiac$2.ti,ab.

21. CABG.ti,ab.

22. PTCA.ti,ab.

23. (stent$4 and (heart or cardiac$4)).ti,ab.

24. Heart Bypass, Left/ or exp Heart Bypass, Right/

25. or/17-24

26. *Rehabilitation Centers/

27. exp Exercise Therapy/

28. *Rehabilitation/

29. exp Sports/

30. Physical Exertion/ or exertion.ti,ab.

31. exp Exercise/

32. rehabilitat$5.ti,ab.

33. (physical$4 adj5 (fit or fitness or train$5 or therap$5 or activit$5)).ti,ab.

34. (train$5 adj5 (strength$3 or aerobic or exercise$4)).ti,ab.

35. ((exercise$4 or fitness) adj5 (treatment or intervent$4 or programs$2 or therapy)).ti,ab.

36. Patient Education as Topic/

37. (patient$2 adj5 educat$4).ti,ab.

38. ((lifestyle or life-style) adj5 (intervent$5 or program$2 or treatment$2)).ti,ab.

39. *Self Care/

40. (self adj5 (manage$5 or care or motivate$5)).ti,ab.

41. *Ambulatory Care/

42. exp Psychotherapy/

43. psychotherap$2.ti,ab.

44. (psycholog$5 adj5 intervent$5).ti,ab.

45. relax$6.ti,ab.

46. exp Relaxation Therapy/ or exp Mind-Body Therapies/

47. exp Counseling/

48. (counselling or counseling).ti,ab.

49. exp Cognitive Therapy/

50. exp Behavior Therapy/

51. ((behavior$4 or behaviour$4) adj5 (modify or modificat$4 or therap$2 or change)).ti,ab.

52. *Stress, Psychological/

53. (stress adj5 management).ti,ab.

54. (cognitive adj5 therap$2).ti,ab.

55. meditat$4.ti,ab.

56. *Meditation/

57. exp Anxiety/

58. (manage$5 adj5 (anxiety or depress$5)).ti,ab.

59. CBT.ti,ab.

60. hypnotherap$5.ti,ab.

61. (goal adj5 setting).ti,ab.

62. (goal$2 adj5 setting).ti,ab.

63. (psycho-educat$5 or psychoeducat$5).ti,ab.

64. (motivat$5 adj5 (intervention or interv$3)).ti,ab.

65. Psychopathology/

66. psychopathol$4.ti,ab.

67. psychosocial$4.ti,ab.

68. distress$4.ti,ab.

69. exp Health Education/

70. (health adj5 education).ti,ab.

71. (heart adj5 manual).ti,ab.

72. Autogenic Training/

73. autogenic$5.ti,ab.

74. or/26-39

75. or/40-73

76. 16 or 25

77. 74 or 75

78. 76 and 77

79. randomized controlled trial/

80. randomized controlled trial.pt.

81. controlled clinical trial.pt.

82. controlled clinical trial/

83. Random Allocation/

84. Double-Blind Method/

85. single-blind method/

86. (random$ or placebo$).ti,ab.

87. ((singl$3 or doubl$3 or tripl$3 or trebl$3) adj5 (blind$3 or mask$3)).ti,ab.

88. exp Research Design/

89. Clinical Trial.pt.

90. exp clinical trial/

91. (clinic$3 adj trial$2).ti,ab.

92. or/79-91

93. 78 and 92

94. (Animals not Humans).sh.

95. 93 not 94

96. limit 95 to yr="2008 -Current"

 

MEDLINE In-Process and Other Non-Indexed Citations Ovid 5 February 2013

1.    (myocard$4 adj5 (ischaemi$2 or ischemi$2)).ti,ab.

2.    ((ischaemi$2 or ischemi$2) adj5 heart).ti,ab.

3.    coronary.ti,ab.

4.    (myocard$5 adj5 infarct$5).ti,ab.

5.    (heart adj5 infarct$5).ti,ab.

6.    angina.ti,ab.

7.    (heart adj5 failure).ti,ab.

8.    (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF").ti,ab.

9.    or/1-8

10. (heart adj5 disease$2).ti,ab.

11. myocard$5.ti,ab.

12. cardiac$2.ti,ab.

13. CABG.ti,ab.

14. PTCA.ti,ab.

15. (stent$4 and (heart or cardiac$4)).ti,ab.

16. or/10-15

17. Physical Exertion/ or exertion.ti,ab.

18. rehabilitat$5.ti,ab.

19. (physical$4 adj5 (fit or fitness or train$5 or therap$5 or activit$5)).ti,ab.

20. (train$5 adj5 (strength$3 or aerobic or exercise$4)).ti,ab.

21. ((exercise$4 or fitness) adj5 (treatment or intervent$4 or programs$2 or therapy)).ti,ab.

22. (patient$2 adj5 educat$4).ti,ab.

23. ((lifestyle or life-style) adj5 (intervent$5 or program$2 or treatment$2)).ti,ab.

24. (self adj5 (manage$5 or care or motivate$5)).ti,ab.

25. psychotherap$2.ti,ab.

26. (psycholog$5 adj5 intervent$5).ti,ab.

27. relax$6.ti,ab.

28. (counselling or counseling).ti,ab.

29. ((behavior$4 or behaviour$4) adj5 (modify or modificat$4 or therap$2 or change)).ti,ab.

30. (stress adj5 management).ti,ab.

31. (cognitive adj5 therap$2).ti,ab.

32. meditat$4.ti,ab.

33. (manage$5 adj5 (anxiety or depress$5)).ti,ab.

34. CBT.ti,ab.

35. hypnotherap$5.ti,ab.

36. (goal adj5 setting).ti,ab.

37. (goal$2 adj5 setting).ti,ab.

38. (psycho-educat$5 or psychoeducat$5).ti,ab.

39. (motivat$5 adj5 (intervention or interv$3)).ti,ab.

40. psychopathol$4.ti,ab.

41. psychosocial$4.ti,ab.

42. distress$4.ti,ab.

43. (health adj5 education).ti,ab.

44. (heart adj5 manual).ti,ab.

45. autogenic$5.ti,ab.

46. or/17-45

47. 9 or 16

48. 46 and 47

49. (random$ or placebo$).ti,ab.

50. ((singl$3 or doubl$3 or tripl$3 or trebl$3) adj5 (blind$3 or mask$3)).ti,ab.

51. (clinic$3 adj trial$2).ti,ab.

52. 49 or 50 or 51

53. 48 and 52

54. limit 53 to yr="2008 -Current"

 

EMBASE Ovid 1980 to 2013 week 5

1.    exp heart disease/

2.    (myocard$4 adj5 (ischaemi$2 or ischemi$2)).ti,ab.

3.    ((ischaemi$2 or ischemi$2) adj5 heart).ti,ab.

4.    exp coronary artery disease/

5.    transluminal coronary angioplasty/

6.    (coronary adj5 (disease$2 or bypass$2 or thrombo$5 or angioplasty$2)).ti,ab.

7.    exp heart infarction/

8.    (myocard$5 adj5 infarct$5).ti,ab.

9.    (heart adj5 infarct$5).ti,ab.

10. heart muscle revascularization/

11. exp Angina Pectoris/

12. angina.ti,ab.

13. exp congestive heart failure/

14. (heart adj5 failure).ti,ab.

15. (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF").ti,ab.

16. or/1-15

17. (heart adj5 disease$2).ti,ab.

18. cardiac$2.ti,ab.

19. CABG.ti,ab.

20. PTCA.ti,ab.

21. (stent$4 and heart).ti,ab.

22. exp extracorporeal circulation/

23. or/17-22

24. 16 or 23

25. *Psychotherapy/

26. psychotherapy$2.ti,ab.

27. (psycholog$5 adj5 intervent$5).ti,ab.

28. relax$6.ti,ab.

29. relaxation training/

30. *counselling/

31. (counselling or counseling).ti,ab.

32. ((behavior$4 or behaviour$4) adj5 (modify or modificat$4 or therap$2 or change)).ti,ab.

33. stress management/

34. (stress adj5 management).ti,ab.

35. *Mediation/

36. meditat$5.ti,ab.

37. (manage$5 adj5 (anxiety or depress$5)).ti,ab.

38. CBT.ti,ab.

39. hypnotherap$2.ti,ab.

40. (goal$2 adj5 setting).ti,ab.

41. (psycho-educat$5 or psychoeducat$5).ti,ab.

42. (motivat$5 adj5 intervent$6).ti,ab.

43. exp psychosocial care/ or exp psychosocial rehabilitation/

44. psychosocial.ti,ab.

45. exp health education/

46. (health adj5 education).ti,ab.

47. (heart adj5 manual).ti,ab.

48. autogenic training/

49. autogenic.ti,ab.

50. *Rehabilitation/

51. rehabilitation center/

52. rehabil$.ti,ab.

53. exp Sport/

54. exp Kinesiotherapy/

55. exp Exercise/

56. exp Physiotherapy/

57. (physical$4 adj5 (fit or fitness or train$5 or therap$5 or activit$5)).ti,ab.

58. (train$5 adj5 (strength$3 or aerobic or exercise$4)).ti,ab.

59. ((exercise$4 or fitness) adj5 (treatment or intervent$4 or programs$2 or therapy)).ti,ab.

60. (aerobic$4 adj5 exercise$4).ti,ab.

61. (kinesiotherapy or physiotherapy).ti,ab.

62. patient education/

63. (patient$2 adj5 educat$4).ti,ab.

64. ((((lifestyle or life) adj1 style) or life-style) adj5 (intervent$5 or program$2 or treatment$2)).ti,ab.

65. exp self care/

66. (self adj5 (manage$5 or care or motivate$5)).ti,ab.

67. exp ambulatory care/

68. (psycho-educat$5 or psychoeducat$5).ti,ab.

69. (motivat$5 adj5 intervent$6).ti,ab.

70. psychosocial care/ or psychosocial rehabilitation/

71. psychosocial.ti,ab.

72. exp health education/

73. (health adj5 education).ti,ab.

74. (heart adj5 manual).ti,ab.

75. autogenic training/

76. autogenic$5.ti,ab.

77. (psycho-educat$5 or psychoeducat$5).ti,ab.

78. (motivat$5 adj5 intervent$6).ti,ab.

79. psychosocial care/ or psychosocial rehabilitation/

80. psychosocial.ti,ab.

81. exp health education/

82. (health adj5 education).ti,ab.

83. (heart adj5 manual).ti,ab.

84. or/25-50

85. or/51-83

86. 84 or 85

87. (random$ or placebo$).ti,ab.

88. ((singl$4 or doubl$4 or tripl$4 or trebl$4) adj5 (blind$4 or mask$4)).ti,ab.

89. (controlled adj1 clinical adj1 trial).ti,ab.

90. randomized controlled trial/

91. or/87-90

92. 24 and 86

93. 91 and 92

94. (animal$ not human$).sh,hw.

95. 93 not 94

96. limit 95 to yr="2008 -Current"

 

PsycINFO Ovid 1806 to January week 5 2013

1.    exp heart disorders/

2.    *Myocardial Infarctions/

3.    exp Ischemia/

4.    *Heart Surgery/

5.    angioplasty.ti,ab.

6.    (heart adj1 bypass).ti,ab.

7.    coronary.ti,ab.

8.    (ischemi$3 or ischaemi$3).ti,ab.

9.    (myocard$5 adj5 infarct$5).ti,ab.

10. (heart adj5 (infarct$5 or failure or attack)).ti,ab.

11. angina.ti,ab.

12. (heart adj5 disease$2).ti,ab.

13. myocard$5.ti,ab.

14. cardiac$4.ti,ab.

15. CABG.ti,ab.

16. PTCA.ti,ab.

17. (HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF").ti,ab.

18. or/1-17

19. exp Physical Activity/

20. exp Sports/

21. *Physical Education/

22. exp Health Behavior/

23. *Physical Fitness/

24. (physical adj1 education).ti,ab.

25. exertion$6.ti,ab.

26. rehabilitat$6.ti,ab.

27. (physical adj5 (fit$5 or train$5 or therap$5 or activit$4)).ti,ab.

28. (train$4 adj5 (strength$4 or aerobic or exercise$2)).ti,ab.

29. ((exercise$3 or fitness) adj5 (treatment or intervent$4 or program$4 or therap$2)).ti,ab.

30. patient with education.ti,ab.

31. exp Client Education/

32. exp Health Promotion/

33. ((lifestyle or life-style) adj5 (intervent$5 or program$2 or treatment$2)).ti,ab.

34. exp Outpatient Treatment/

35. or/19-34

36. exp Psychotherapy/

37. psychotherapy$2.ti,ab.

38. exp Treatment/

39. (psycholog$4 adj5 intervent$5).ti,ab.

40. exp Counseling/

41. exp Coping Behavior/

42. *Meditation/

43. *Autogenic Training/

44. exp Health Education/

45. relax$6.ti,ab.

46. (counselling or counseling).ti,ab.

47. ((behavior or behaviour) adj5 (modif$5 or therap$5 or rehabilit5 or change)).ti,ab.

48. (stress adj5 management).ti,ab.

49. meditat$5.ti,ab.

50. (manage$5 adj5 (anxiety or depress$5)).ti,ab.

51. ((cbt or cognitive$2) adj5 therap$3).ti,ab.

52. hypnotherap$3.ti,ab.

53. (psycho-educat$6 or psychoeducat$6).ti,ab.

54. (motivat$5 adj5 intervent$5).ti,ab.

55. (self adj5 manag$6).ti,ab.

56. autogenic$3.ti,ab.

57. (goal adj5 setting).ti,ab.

58. (health adj5 education).ti,ab.

59. (heart adj1 manual).ti,ab.

60. or/36-59

61. 18 and (35 or 60)

62. (random$5 or placebo$5).ti,ab.

63. ((single$4 or double$4 or triple$4) and (blind$4 or mask or sham$4 or dummy)).ti,ab.

64. RCT.ti,ab.

65. or/62-64

66. 61 and 65

67. limit 66 to yr="2008 -Current"

 

CINAHL EBSCOhost, search date 5 February 2013

1.    TI((myocard* N5 ischaemi*) or (myocard* N5 ischemi*) or (heart N5 ischaemi*) or (heart N5 ischemi*)) OR AB((myocard* N5 ischaemi*) or (myocard* N5 ischemi*) or (heart N5 ischaemi*) or (heart N5 ischemi*))

2.    TI(coronary) or AB(coronary)

3.    TI((myocard* N5 infarc*) or (heart N5 infarc*)) or AB((myocard* N5 infarc*) or (heart N5 infarc*))

4.    TI(angina) OR AB(angina)

5.    TI(heart N5 failure) or AB(heart N5 failure)

6.    TI(heart N5 diseas*) or AB(heart N5 diseas*)

7.    TI(cardiac) or AB(cardiac)

8.    TI(CABG) or AB(CABG)

9.    TI(PTCA) or AB(PTCA)

10. TI(Stent* and (heart or cardiac*)) or AB(Stent* and (heart or cardiac*))

11. (MH "Myocardial Ischemia+")

12. (MH "Myocardial Infarction+")

13. (MH "Coronary Artery Bypass+")

14. (MH "Coronary Disease+")

15. TI(cardiac N5 patient*) or AB(cardiac N5 patient*)

16. TI(Cardiomyopathies) or AB(Cardiomyopathies)

17. (MH "Myocardial Revascularization+")

18. (MH "Heart Diseases+")

19. (MH "Cardiovascular Diseases+")

20. (MH "Heart Failure+")

21. (MH "Angina Pectoris+")

22. TI(HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF") or AB(HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF")

23. S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22

24. (MM "Rehabilitation")

25. (MM "Sports")

26. (MM "Physical Activity")

27. (MH "Muscle Strengthening+")

28. (MH "Aerobic Exercises+")

29. (MH "Physical Fitness+")

30. (MH "Patient Education+")

31. (MH "Therapeutic Exercise+")

32. TI(rehabilitat*) or AB(rehabilitat*)

33. TI((physical* N5 fit) or (physical N5 fitness) or (physical N5 train*) or (physical N5 therap*) or (physical N5 activit*)) or AB((physical* N5 fit) or (physical N5 fitness) or (physical N5 train*) or (physical N5 therap*) or (physical N5 activit*))

34. TI((train N5 strength) or (train N5 aerobic) or (train N5 exercis*)) or AB((train N5 strength) or (train N5 aerobic) or (train N5 exercis*))

35. TI((exercise N5 treatment) or (fitness N5 treatment) or (exercise N5 intervent*) or (fitness N5 intervent*) or (exercise N5 program*) or (fitness N5 program) or (exercise N5 therapy) or (fitness N5 therapy)) or AB((exercise N5 treatment) or (fitness N5 treatment) or (exercise N5 intervent*) or (fitness N5 intervent*) or (exercise N5 program*) or (fitness N5 program) or (exercise N5 therapy) or (fitness N5 therapy))

36. TI(patient* N5 educat*) or AB(patient* N5 educat*)

37. TI ((lifestyle N5 intervent*) or (life-style N5 intervent*) or (lifestyle N5 program*) or (life-style N5 program*) or (lifestyle N5 treatment) or (life-style N5 treatment)) OR AB ((lifestyle N5 intervent*) or (life-style N5 intervent*) or (lifestyle N5 program*) or (life-style N5 program*) or (lifestyle N5 treatment) or (life-style N5 treatment))

38. (MH "Self Care+")

39. TI((self N5 manage*) or (self N5 care) or (self N5 motivat*)) or AB((self N5 manage*) or (self N5 care) or (self N5 motivat*))

40. (MM "Ambulatory Care")

41. TI(aerobic) or AB(aerobic)

42. TI(resistance W1 train*) or AB(resistance W1 train*)

43. TI(muscle W1 strength*) or AB(muscle W1 strength*)

44. TI(resistance W1 train*) or AB(resistance W1 train*)

45. TI(muscle W1 strength*) or AB(muscle W1 strength*)

46. (MH "Psychotherapy+")

47. TI(psychotherap*) or AB(psychotherap*)

48. TI(psycholog* N5 intervent*) or AB(psycholog* N5 intervent*)

49. TI(relax) or AB(relax)

50. (MH "Relaxation Techniques+")

51. TI(counselling or counseling) or AB(counselling or counseling)

52. (MH "Counseling+")

53. TI((behavio?r* N5 modify) or (behavio?r* N5 modificat*) or (behavio?r* N5 therap*) or (behavio?r* N5 change)) or AB((behavio?r* N5 modify) or (behavio?r* N5 modificat*) or (behavio?r* N5 therap*) or (behavio?r* N5 change))

54. (MM "Stress Management")

55. TI(stress N5 manag*) or AB(stress N5 manag*)

56. TI(cognitive N5 therap*) or AB(cognitive N5 therap*)

57. (MM "Meditation")

58. TI(meditat*) or AB(meditat*)

59. (MH "Anxiety+")

60. TI((manage* N5 anxiety) or (manage* N5 depress*)) or AB((manage* N5 anxiety) or (manage* N5 depress*))

61. TI(CBT) or AB(CBT)

62. TI(hypnotherap*) or AB(hypnotherap*)

63. TI(goal* N5 setting) or AB(goal* N5 setting)

64. TI(psycho-educat* or psychoeducat*) or AB(psycho-educat* or psychoeducat*)

65. TI((motivat* N5 interv*) or (motivate* N5 intervent*)) or AB((motivat* N5 interv*) or (motivate* N5 intervent*))

66. TI(psychosocial*) or AB(psychosocial*)

67. (MH "Health Education+")

68. TI(health N5 educat*) or AB(health N5 educat*)

69. TI(heart W1 manual) or AB(heart W1 manual)

70. TI(autogenic*) or AB(autogenic*)

71. S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31 OR S32 OR S33 OR S34 OR S35 OR S36 OR S37 OR S38 OR S39 OR S40 OR S41 OR S42 OR S43 OR S44 OR S45

72. S46 OR S47 OR S48 OR S49 OR S50 OR S51 OR S52 OR S53 OR S54 OR S55 OR S56 OR S57 OR S58 OR S59 OR S60 OR S61 OR S62 OR S63 OR S64 OR S65 OR S66 OR S67 OR S68 OR S69 OR S70

73. S71 OR S72

74. S23 AND S73

75. PT CLINICAL TRIAL

76. (MH "Clinical Trials+")

77. TI (random* or placebo*) or AB (random* or placebo*)

78. TI(singl* or double* or triple* or treble* and (blind* or mask*)) or AB(singl* or double* or triple* or treble* and (blind* or mask*))

79. TI(controlled w1 clinical w1 trials) or AB(controlled w1 clinical w1 trials)

80. S75 OR S76 OR S77 OR S78 OR S79

81. S74 AND S80 date limit=2008-current

 

Web of Science, search date 6 February 2013

1.    TS=((myocard*) SAME (isch?emia or infarct* or revasculari?*))

2.    TS=((coronary* or heart*) SAME (by?pass or disease*))

3.    TS=((heart) SAME (infarct* or isch?emia or failure or attack))

4.    TS=(angina or cardiac* or PTCA or CABG)

5.    TS=(HFNEF or HFPEF or HFREF or "HF NEF" or "HF PEF" or "HF REF")

6.    #1 OR #2 OR #3 OR #4 OR #5

7.    TS=(rehab* or educat*)

8.    #6 AND #7

9.    TS=(random* or placebo*)

10. TS=((singl* or doubl* or tripl* or trebl*) SAME (blind* or mask*))

11. TS=("clinic* trial*")

12. #9 OR #10 OR #11

13. #8 AND #12

Databases=SCI-EXPANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2008-2013

 

What's new

DateEventDescription
1 November 2013New citation required but conclusions have not changedThis update review identified a further 14 trials. Whilst conclusions of the review do not change, this update provides broader body of evidence of the benefit of exercise-based interventions that includes HFPEF patients and delivery in a home-based setting
14 February 2013New search has been performedSearches updated

History

Protocol first published: Issue 4, 2001
Review first published: Issue 3, 2004

DateEventDescription
18 May 2004New citation required and conclusions have changedSubstantive amendment

Contributions of authors

Rod Taylor and Viral Sagar led the design of the update review.

Simon Briscoe developed the updated the searches.

Viral Sagar and Rod Taylor undertook study selection, data extraction, assessment of risk of bias and data analysis.

Viral Sagar and Rod Taylor wrote the first draft of the update review, and all co-authors commented on a draft of the report.

Declarations of interest

Rod Taylor and Hayes Dalal are co-lead investigators on an ongoing National Institute for Health Research (NIHR) Programme Grants for Applied Research funded study - Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) - to develop and evaluate the costs and outcomes of a home-based self help heart failure exercise rehabilitation manual (RP-PG-1210-12004).

Sources of support

Internal sources

  • None, Not specified.

External sources

  • None, Not specified.

Differences between protocol and review

Compared with previous version of this review, the inclusion criteria extended to include HFPEF.

Notes

None.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Austin 2005

MethodsParallel group RCT
Participants

N Randomised: 200 (exercise 100; control 100)

Diagnosis (% of participants):

Aetiology: ischaemic 77%; hypertension 15.5%; DCM 5.5%; other 2%

NYHA: Class II 51.5%; Class III 48.5%

LVEF: 40-35%: 16.5%; < 35-30%: 45%; < 30%: 38.5%

Case mix: 100% as above

Age (yr): exercise 71.9 (SD 6.3); control 71.8 (SD 6.8)

Male: 43%
White: not reported

Inclusion/exclusion criteria

Inclusion: age > 60 yr, NYHA Class II or III, and LVSD < 40%, confirmed by echocardiography

Exclusion: diastolic dysfunction, significant co-morbidity preventing entry into study because of terminal disease or an inability to exercise (e.g. severe musculoskeletal disorder, unstable IHD, advanced valvular disease), resident outside the catchment area or in a long-term care establishment

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: aerobic endurance training and low resistance training/high repetitive muscular strength work

Frequency: 2 sessions/wk (for 8 wk), 1 session/wk (16 wk) plus 3 sessions/wk at home

Duration: 2.5 hr class (8 wk) and 1 hr class (next 16 wk)

Intensity: not reported

Modality: not reported

Setting: hospital and home

Other: none

OutcomesHRQoL (MLWHFQ and EuroQol/EQ-5D); healthcare utilisation (length of stay of hospital, admissions arising from heart disease, prescribed HF medication); mortality
ComparisonStandard care group (including monitoring of clinical status, explanation of HF and its treatment self monitoring; dietary advice and contact details of clinical nurse specialist)
Country and setting

UK

Single centre

Follow-up6 months and 5 yr (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"A computer was used to generate a list of random numbers"
Allocation concealment (selection bias)Low risk"The numbers, placed in plain sealed envelopes by a university colleague prior to patient recruitment, were allocated to the participants by a hospital colleague unconnected with the study. The allocation schedule was not broken until the trial was completed"
Blinding (performance bias and detection bias)
All outcomes
High riskNo, for HRQoL. Data on deaths, admissions from the hospital records department
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported
Intention-to-treat analysis?Low riskAlthough term ITT not stated it appears from CONSORT diagram that ITT analysis undertaken
Incomplete outcome data?Low riskCONSORT diagram presented showing participant flow. No imputation or sensitivity analysis to assess impact of loss or follow-up
Groups balanced at baseline?Low risk"There are no significant differences in the baseline parameters of the standard care and experimental groups"
Groups received same intervention?Low riskYes, both groups received usual medical care and the only difference between groups was the exercise intervention

Belardinelli 1999

MethodsParallel group RCT
Participants

N Randomised: 99 (exercise 50; control 49)

Diagnosis (% of participants):

Aetiology: ischaemic cardiomyopathy 85%; idiopathic DCM 15%

NYHA: Class II 49%; Class III 34%; Class IV 17%

LVEF: exercise 28.4 (SD 6); control 27.9 (SD 5)

Case mix: see above

Age (yr): exercise 56 (SD 7); control 53 (SD 9)

Male: 89%
White: not reported

Inclusion/exclusion criteria

Inclusion: HF, LVEF < 40%, and sinus rhythm, diagnosis of CHF based on clinical symptoms and signs with or without radiological evidence of pulmonary congestion

Exclusion: unstable angina, recent acute MI, decompensated congestive HF, haemodynamically significant valvular heart disease, significant chronic pulmonary illness, uncontrolled hypertension, renal insufficiency (serum creatinine > 2.5 mg/dL), and orthopaedic or neurological limitations)

Interventions

Exercise: Total duration: 14 month; 8 wk supervised then 12 months maintenance

Aerobic/resistance/mix: aerobic

Frequency: 2-3 sessions/wk

Duration: 40 min/session

Intensity: 60% max VO2

Modality: cycling

Setting: hospital-based programme

Other: all sessions were supervised by a cardiologist

OutcomesHRQoL (MLWHFQ); mortality; morbidity; cost-effectiveness
ComparisonStandard medical care
Country and setting

Italy

Single centre

Follow-up14 and 26 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods, reported in results
Intention-to-treat analysis?Unclear riskNot reported
Incomplete outcome data?Low riskLosses to follow-up reported
Groups balanced at baseline?Low risk"The baseline characteristics of the study population are shown in Table 1. The 2 groups were well balanced with respect to most characteristics, including peak VO2, New York Heart Association functional class, and left ventricular ejection fraction. There were no differences in type and doses of medications, blood chemistry, and previous cardiac events"
Groups received same intervention?Unclear riskNot reported

Belardinelli 2012

MethodsParallel group RCT
Participants

N Randomised: 123 (exercise 63; control 60)

Diagnosis (% of participants):

Aetiology: ischaemic 80%; non-ischaemic 20%

NYHA: Class II 59%; Class III 41%

LVEF: 37 (SD 8)

Case mix: see above

Age (yr): 59 (SD 14)

Male: 78%

White: not reported

Inclusion/exclusion criteria

Inclusion: clinical stability for 3 months before enrolment, LVEF < 40% and ability to exercise

Exclusion: haemodynamically significant valvular heart disease, uncontrolled DM and hypertension, orthopaedic or neurological problems, and renal insufficiency (creatinine > 2.5 mg/dL)

Interventions

Exercise: Total duration: 10 yr; 8 wk supervised then 12 months maintenance

Aerobic/resistance/mix: aerobic

Frequency: 2-3 sessions/wk

Duration: 40 min/session

Intensity: 60% max VO2 for first 2 months, and thereafter at 70% max VO2

Modality: cycling

Setting: Hospital and home-based

Other: trained participants were encouraged to exercise without supervision at home at least a third time, performing aerobic activities at the same HR as the other 2 supervised sessions.

Exercises sessions held at the hospital were supervised by cardiologists. Authors emphasise that the supervised element was maintained over the 10 yr of follow-up.

OutcomesHRQoL (MLWHQ), mortality, morbidity (including hospitalisation), cost-effectiveness
ComparisonStandard medical care. Participants were instructed to continue with their usual home daily physical activities, avoiding exercise training in a supervised environment. They were free to perform aerobic activities such as walking, cycling (home or outside), and swimming, avoiding a duration of longer than 30 min. Authors advised control group participants to walk and perform usual physical activities.
Country and setting

Italy

Single centre

Follow-up10 yr (every 12 months) (after randomisation)
NotesEvery 6 months, participants exercised at the hospital, and then they returned to a coronary club, where they exercised the rest of the year.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods, reported in results
Intention-to-treat analysis?Low risk"All analysis were performed with an intention-to-treat principle"
Incomplete outcome data?Low risk

Losses to follow-up reported.

Drop-out rate was 3% on average in the exercise group. 2/63 did not complete the protocol, 1 because of a car accident and the other for personal reasons. 3/60 in control group decided to withdraw from study for reasons unrelated to their clinical status.

Groups balanced at baseline?Low risk"The baseline characteristics of the study population are shown in Table 1. The 2 groups were well balanced with respect to most characteristics, including peak VO2, New York Heart Association functional class, left ventricular ejection fraction. There were no difference in type and doses of medication, blood chemistry, and previous cardiac events."
Groups received same intervention?Low riskBoth groups appeared to receive same interventions apart from CR intervention.

Bocalini 2008

MethodsParallel group RCT
Participants

N Randomised: 42 (exercise 22; control 20)

Diagnosis (% of participants):

Aetiology: MI 45.2%; systemic hypertension 19%; dilated Chagas' cardiomyopathy 11.9%; DM 4.8%; other 19.1%

NYHA: Class II or III

LVEF: ≤ 45%

Case mix: 100% as above

Age (yr): exercise 61 (SD 12); control 60 (SD 11)

Male: 88%

White: not reported

Inclusion/exclusion criteria

Inclusion: EF < 45%, symptoms of NYHA functional Class II or III, optimised pharmacological therapy established at least 4 wk before inclusion in the study, and compensated HF state at least 2 months prior

Exclusion: age < 50 yr, NYHA functional Class IV, clinical instability in the preceding 2 months, non-optimised therapy, uncontrolled arrhythmias, MI within the last 2 months, surgery-associated cardiomyopathy, pulmonary disease or other co-morbid conditions that limit physical exercise, accentuated severe cardiac symptoms (hypotension, complex ventricular arrhythmia, progressive worsening of dyspnoea and significant ischaemia at low rates) during ergometric tests, regular participation in some exercise programme within the last 6 months and a frequency in training protocol of < 80%

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: 90 min

Intensity: target HR (50% of work in the max HR)

Modality: walking on a treadmill

Setting: not reported

Other: relaxation and stretching exercises before and after every session

OutcomesHRQoL (shortened version of World Health Organization Quality of Life questionnaire), hospitalisation
ComparisonUsual medical therapy - individual dietary guidance and pharmacological therapy
Country and setting

Brazil

Single-centre

Follow-up6 months (after randomisation)
Notes

Initially randomised 53 participants, excluded data from participants who withdrew, lost to follow-up, etc. and hence 42 participants were analysed

Although setting not reported, the exercise programme was described as "supervised"

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?High risk"During the follow-up, medicine doses were not modified except for those that presented impairment of symptoms and, consequently, these patients were excluded from the analysis"
Incomplete outcome data?High risk"…3 patients from the untrained group experienced an impairment of symptoms and were hospitalized"
Groups balanced at baseline?Low riskTable 1 of the publication shows groups are well balanced
Groups received same intervention?Low risk"All patients continued with pharmacological therapy and individual dietary guidance"

DANREHAB 2008

MethodsParallel group RCT
Participants

N randomised: 91 (exercise 45; control 46)

Age (yr): exercise: median 66 (range 33-91); control median (range 29-94)

Male: 90%

White: not reported

Inclusion/exclusion criteria

Inclusion: present symptoms of CHF and objective findings or effect of medication

Exclusion: mental disorders and social problems (such as dementia, alcoholism or drug addiction). Transferred to other department or hospital at discharge. Severe illness, including NYHA Class IV. Living at nursing home. Did not speak Danish. Refused consent

Interventions

Exercise: Total duration: 12 wk

Aerobic/resistance/mix: mix

Frequency: 3 sessions/wk

Duration: 90 min/session

Intensity: 50% max HR

Modality: not reported

Setting: supervised centre-based plus home-based also encouraged to continue

Other: the physical exercise was conducted as a mixture of endurance and strengthening training using various upper and lower body modalities easily implemented as activities that the participants could perform at home. CR included participant education, exercise training, dietary counselling, smoking cessation, psychosocial support, and risk factor management and clinical assessment. All components included theoretical and practical approaches followed by individual follow-up and feedback. The lifestyle intervention strategy was based on the stages of change model and self efficacy theory. The lifestyle intervention was designed as group intervention, but individual counselling was included

Outcomes

Primary: composite outcome measure included overall mortality, MI or acute first-time re-admission due to heart disease other than MI

Secondary: collected data using an adapted standardised interview questionnaire and a postal questionnaire (e.g. SF-36, HADS), clinical examination and blood tests

ComparisonUsual care participants were offered follow-up treatment prescribed by the discharging physician either as outpatient control or by the general practitioner. The pharmaceutical treatment followed routine clinical practice based on current national guidelines. The discharging nurse or physician determined whether participants were referred to smoking cessation and dietary counselling parallel to outpatient treatment
Country and setting

Demark

Single centre

Follow-up12-months
NotesHF subset of 770 participants randomised, other participants with coronary heart disease and were high risk but no disease. Randomisation stratified by indication
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Patients who gave informed consent were randomized using a centralized randomization procedure administered by the Copenhagen Trial Unit. The randomization was stratified according to risk group (CHF, IHD, or HR) based on a random-permuted multiblock within-stratum method"
Allocation concealment (selection bias)Low riskAs above
Blinding (performance bias and detection bias)
All outcomes
Low risk"Because of the nature of CR, the interventions were open to the investigators and the patients. Investigator independent outcome data from registries were chosen to ensure blinded assessment and outcome analysis"
Selective reporting (reporting bias)Low riskAll outcomes listed in methods reported in results
Intention-to-treat analysis?Low riskITT analysis stated
Incomplete outcome data?Low risk81% overall follow-up at 12-months
Groups balanced at baseline?Low risk"Patients were well matched at entry"
Groups received same intervention?Low riskBoth groups received control care

Davidson 2010

MethodsParallel group RCT
Participants

N Randomised: 105 (exercise 53; control 52)

Diagnosis (% of participants):

Aetiology: not reported

NYHA: Class I: exercise 2%; control 0%; Class II: exercise 38%; control 33%; Class III: exercise 60%; control 67%; Class IV: exercise 0%; control 0%

LVEF: not reported

Case mix: as above

Age (yr): exercise 71.6 (SD not reported); control 73.9 (SD not reported)

Male: 67%

White: not reported

Inclusion/exclusion criteria

Inclusion: participants were of any age with a diagnosis of HF of any aetiology, and NYHA Class I-IV. All participants cleared by their physician to participate in the exercise group

Exclusion: participants with unstable angina pectoris were ineligible to participate

Interventions

Exercise: Total duration: 12 wk

Aerobic/resistance/mix: aerobic

Frequency: 1 session/wk

Duration: 30-50 min

Intensity: not reported

Modality: gymnasium: treadmills, stationary cycles, recumbent cycles

Home-based: hall walks, stairs and sporting activities such as lawn bowls

Setting: supervised gymnasium, home-based programme tailored to participant's need

Other: also attended a nurse-coordinated CR clinic with emphasis of self-management. A group-based educational session was conducted for study participants and their families. Exercise group attended the nurse-co-ordinated CR clinic, where comprehensive assessment was performed by the physiotherapist, CR co-ordinator and occupational therapist

OutcomesHRQoL (MLWHFQ), all-cause and cardiovascular-related hospital admission, mortality
ComparisonInformation session and then usual medical care
Country and setting

Australia

Single-centre

Follow-up12 months (after randomisation)
NotesThe trial had to be stopped prematurely at 12 months following introduction of chronic and complex care for people with CHF by the New South Wales Health Department. "In view of trends in favour of the intervention group and emerging evidence from other studies, it was considered unethical and untenable to continue randomization in view of the policy mandate. When the trial was stopped there were 53 participants in the intervention group and 52 participants in the usual care group"
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Participants were randomized to either the intervention or control group by means of a computer-generated program"
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"The randomization technique was blinded to the investigators until the close of the study"
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported
Intention-to-treat analysis?Low riskAlthough not reported as ITT analysis, groups did appear to be analysed according to original randomised allocation
Incomplete outcome data?Low risk"No participants were lost to follow-up"
Groups balanced at baseline?Low risk"…there were few differences between intervention and usual care groups, indicating success of randomization. The most important difference on clinical variable was that a significantly greater proportion of people in the intervention group were taking spironolactone at baseline"
Groups received same intervention?Low riskBoth groups appeared to receive same interventions apart from CR intervention

Dracup 2007

MethodsParallel group RCT
Participants

N Randomised: 173 (exercise 86; control 87)

Diagnosis (% of participants):

Aetiology: ischaemic; idiopathic; valvular; DCM; other

NYHA: Class II-IV

LVEF: 26.4 (SD 6.8)

Case mix: 100% as above

Age (yr): 54 (SD 12.5)

Male: 71.7%
White: 60.1 

Inclusion/exclusion criteria

Inclusion: English-speaking, age 18-80 yr, NYHA II-IV and LVSD with LVEF < 40% as documented by echocardiogram or radionuclide ventriculography within < 6 months, and sinus rhythm

Exclusion: MI or recurrent angina within < 3 months, orthopaedic impediments to exercise, severe obstructive pulmonary disease with a forced expiratory volume < 1 L in 1 second as measured by spirometry, stenotic valvular disease as measured by echocardiogram, history of uncontrolled ventricular tachyarrhythmias (documented by electrophysiology study or 24-hr Holter monitor), or absence of an implantable cardioverter-defibrillator despite a history of sudden cardiac death

Interventions

Exercise: Total duration: unclear (6 months or 1 year)

Aerobic/resistance/mix: mix

Frequency: 4 sessions/wk

Duration: 10-45 min

Intensity: 40-60% max HR

Modality: walking

Setting: home-based

Other: "After six weeks resistive training component involved both upper and lower extremity strengthening. Resistance training was prescribed at 80% of one repetition maximum, which is the maximal weight lifted one time, for 2 sets of 10 repetitions using seated biceps curls to strengthen the arms & seated lateral raises to strengthen shoulders. A second set of 10 repetitions at 80% of one repetition maximum was also prescribed…"

OutcomesHRQoL (MLWHFQ), mortality, hospitalisation
ComparisonMaintained usual level of daily activities. No exercise component
Country and setting

USA

Single centre

Follow-up6 and 12 months (after randomisation)
Notes

Home-based exercise programme

Subgroup analysis reported: Evangelista 2010

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskBlinding reported for physical activity (accelerometer) outcome but not reported for other outcomes
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported
Intention-to-treat analysis?Low riskAlthough not reported as ITT analysis, groups did appear to be analysed according to original randomised allocation
Incomplete outcome data?Low risk"Two patients (one from the experimental and one from the control group) were lost to follow-up within the first three months of enrollment. One was incarcerated and the second left the geographic area with no forwarding information. The remaining 173 patients compose the final study"
Groups balanced at baseline?Low risk

Current version: "There were no differences between the control and exercise groups at baseline with respect to sociodemographic variables (Table I) and most clinical characteristics. However, patients in the exercise group had a significantly higher likelihood of having a history of coronary heart disease and taking antiplatelet medication than in the control group"

Our version: "There were no significant differences in any of baseline characteristics between the 2 groups, except for angiotensin-converting enzyme (ACE) inhibitor; adherers were more likely to use ACE inhibitors than nonadherers (84% vs 60%; P = 0.039)"

Groups received same intervention?Low risk"Research nurses made home visits weekly for the first two weeks and then monthly to assess protocol adherence, correct use of the pedometer, and tolerance to the exercise program. The home visits also served as a form of attention control in the care- as-usual group. All clinical questions were referred to the patient's cardiologist"

Gary 2010 (comp)

MethodsParallel group RCT
Participants

N Randomised: 28 (CBT 10; CBT and exercise 18)

Diagnosis (% of participants):

Aetiology: not reported

NYHA: Class II 43.3%; Class III 56.7% (as a whole)

LVEF: ≥ 15%

Case mix: 100% as above

Age (yr): 65.8 (SD 13.5)

Male: 41.9%

White: not reported

Inclusion/exclusion criteria

Inclusion: 1. documented medical diagnosis of HF; 2. LVEF ≥ 15% documented within the last year by echocardiogram, cardiac catheterisation ventriculography or radionuclide ventriculography; 3. receiving therapy for HF according to guidelines published by the American College of Cardiology American Heart recommendations (angiotensin-converting enzyme inhibitors, diuretics, beta-blockers, angiotensin receptor blockers, hydralazine and nitrate combination, etc.); 4. Hamilton Rating Scale for Depression (HAM-D) score ≥ 11; 5. positive results on the Mini International Neuropsychiatric Interview (Mini) for minor or major depression and 6. DSM-IV diagnosis for depression for 14 days; or 7 days if history of major depressive disorder in the last 6 months. Participants also had to be 1. English speaking, 2. living independently (non-institutionalised) within 100 miles of Atlanta, GA, 3. able to respond to questions appropriately, 4. able to hear adequately to respond to verbal questions, 5. not involved in any structured exercise programme or walking 3 times/wk for a minimum of 20 min, 6. not participating in any psychotherapy and 7. not hospitalised within the last 60 days

Exclusion: 1. suicide ideation according to psychiatric assessment or Mini evaluation; 2. major psychiatric co-morbidity such as schizophrenia, personality disorder or dementia; 3. planned surgery; 4. not diagnosed with HF in the past 3 months; 5. renal insufficiency (serum creatinine >2.5 mg/dL); 6. uncontrolled hypertension; 7. acute bereavement or loss of significant other within the last month or currently involved in family crisis such as divorce; 8. any disorder interfering with independent ambulation; and 9. terminal illness such as cancer

Interventions

Exercise: Total duration: 12 wk

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: 30-45 min/session, max 1 hr

Intensity: Borg < 15 ('moderate')

Modality: walking

Setting: home-based

Other: exercise + CBT group also received 12 wk weekly 1-hr sessions of CBT for 12 wk. No other co-interventions mentioned

OutcomesHRQoL (MLWHFQ) and mortality
Comparison

Usual care

"Participants assigned to the UC [usual care] group received no information or counselling from their health care provider other than that normally provided"

Country and setting

USA

Single-centre

Follow-up24 wk (after randomisation)
NotesExercise group participants had 12 weekly face-to-face home visits by research nurse to monitor walking progress and to tailor the exercise prescription. "At the first home visit for EX, the research nurse (1) educated the patient on the rationale for EX in HF; (2) instructed on self-monitoring of symptoms [dyspnea, heart rate (HR), fatigue] during walking; (3) provided the patient with a Polar monitor and instruction on how to use it; (4) provided patient with EX logs and instructions; (5) instructed on use of the 6- to 20-point Borg's rate of perceived exertion (RPE) scale; (6) provided patient with blood pressure cuff and weight scale, if not available; and (7) observed participant response to walking out side home"
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"Data collectors were blinded to group assignment"
Selective reporting (reporting bias)Low riskOutcome described in methods are reported in results
Intention-to-treat analysis?Low riskAlthough not stated, CONSORT diagram suggests groups analysed according to initial randomised allocation
Incomplete outcome data?Low riskQUORUM diagram and details of losses to follow-up reported. In exercise group, 1 patient died and 3 withdrew at 24 wk. In usual care group, 2 participants and 1 participant withdraw at 12 and 24 wk, respectively. In combined CBT/exercise group 2 withdrew at 12 wk. 1 lost to follow-up and 1 withdrew at 24 wk. In CBT group, 1 withdrew at 12 wk and 24 wk. 1 died and 1 lost to follow-up at 24 wk
Groups balanced at baseline?Low risk"There were no BL differences between groups on any demographic or outcome variables"
Groups received same intervention?Low riskGroups appeared to receive same care other that exercise and CBT interventions

Gary 2010 (exalone)

MethodsParallel group RCT
Participants

N Randomised: 37 (exercise alone 20; control 17)

CBT only group not included to this review

Diagnosis (% of participants):

Aetiology: not reported

NYHA: Class II 43.3%; Class III 56.7%

LVEF: ≥ 15%

Case mix: 100% as above

Age (yr): 65.8 (SD 13.5)

Male: 41.9%

White: not reported

Inclusion/exclusion criteria

Inclusion: 1. documented medical diagnosis of HF; 2. LVEF of ≥ 15% documented within the last year by echocardiogram, cardiac catheterisation ventriculography or radionuclide ventriculography; 3. receiving therapy for HF according to guidelines published by the American College of Cardiology American Heart recommendations (angiotensin-converting enzyme inhibitors, diuretics, beta-blockers, angiotensin receptor blockers, hydralazine and nitrate combination, etc.); 4. Hamilton Rating Scale for Depression (HAM-D) score ≥ 11; 5. positive results on the Mini International Neuropsychiatric Interview (Mini) for minor or major depression; and 6. DSM-IV diagnosis for depression for 14 days; or 7 days if history of major depressive disorder in the last 6 months. Participants also had to be 1. English speaking, 2. living independently (non-institutionalised) within 100 miles of Atlanta, GA, 3. able to respond to questions appropriately, 4. able to hear adequately to respond to verbal questions, 5. not involved in any structured exercise programme or walking 3 times/wk for a minimum of 20 min, 6. not participating in any psychotherapy, and 7. not hospitalised within the last 60 days

Exclusion: 1. suicide ideation according to psychiatric assessment or Mini evaluation; 2. major psychiatric co-morbidity such as schizophrenia, personality disorder or dementia; 3. planned surgery; 4. not diagnosed with HF in the past 3 months; 5. renal insufficiency (serum creatinine >2.5 mg/dL); 6. uncontrolled hypertension; 7. acute bereavement or loss of significant other within the last month or currently involved in family crisis such as divorce; 8. any disorder interfering with independent ambulation; and 9. terminal illness such as cancer

Interventions

Exercise: Total duration: 12 wk

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: 30-45 min/session, max 1 hr

Intensity: Borg < 15 ('moderate')

Modality: walking

Setting: home-based

Other: none reported

OutcomesHRQoL (MLWHFQ) and mortality
Comparison

Usual care

"Participants assigned to the UC [usual care] group received no information or counselling from their health care provider other than that normally provided."

Country and setting

USA

Single-centre

Follow-up24 wk
NotesExercise group participants had 12 weekly face-to-face home visits by research nurse to monitor walking progress and to tailor the exercise prescription. "At the first home visit for EX, the research nurse (1) educated the patient on the rationale for EX in HF; (2) instructed on self-monitoring of symptoms [dyspnea, heart rate (HR), fatigue] during walking; (3) provided the patient with a Polar monitor and instruction on how to use it; (4) provided patient with EX logs and instructions; (5) instructed on use of the 6- to 20-point Borg's rate of perceived exertion (RPE) scale; (6) provided patient with blood pressure cuff and weight scale, if not available; and (7) observed participant response to walking out side home"
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"Data collectors were blinded to group assignment"
Selective reporting (reporting bias)Low riskOutcome described in methods were reported in results
Intention-to-treat analysis?Low riskAlthough not stated, CONSORT diagram suggests groups analysed according to initial randomised allocation
Incomplete outcome data?Low riskQUORUM diagram and details of losses to follow-up reported. In exercise group, 1 participant died and 3 withdrew at 24 wk. In usual care group, 2 participants and 1 participant withdrew at 12 and 24 wk, respectively. In combined CBT/exercise group, 2 withdrew at 12 wk. 1 lost to follow-up and 1 withdrew at 24 wk. In CBT group, 1 withdrew at 12 wk and 24 wk. 1 died and 1 lost to follow-up at 24 wk
Groups balanced at baseline?Low risk"There were no BL differences between groups on any demographic or outcome variables"
Groups received same intervention?Low riskGroups appeared to receive same care other that exercise and CBT interventions

Giannuzzi 2003

MethodsParallel group RCT
Participants

N Randomised: 90, 45 each group

Diagnosis (% of participants):

Aetiology: HF secondary to idiopathic DCM; ischaemic heart disease; valvular disease

NYHA: Class II-III

LVEF: exercise 25% (SD 4); control 25% (SD 4)

Case mix: 100%

Age (yr): exercise 60 (SD 7); control 61 (SD 7)

Male: not reported
White: not reported

Inclusion/exclusion criteria

Inclusion: 1. HF secondary to idiopathic DCM, ischaemic heart disease or valvular disease; 2. echocardiographic ejection fraction < 35%; 3. clinical stability for at least 3 months under optimised therapy; 4. NYHA functional Class II to III; 5. peak oxygen uptake (VO2) < 20 mL/kg/min; and 6. echocardiographic images of adequate quality for quantitative analysis

Exclusion: any systemic disease limiting exercise, hypertrophic cardiomyopathy, valvular disease requiring surgery, angina pectoris, sustained ventricular arrhythmias, severe hypertension, excess variability (> 10%) at baseline cardiopulmonary exercise test and inability to participate in a prospective study for any logistic reason 

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: aerobic

Frequency: 3-5 sessions/wk

Duration: 30 min

Intensity: 60% peak VO2

Modality: exercise cycle, daily brisk walk, callisthenic. In addition, requested to take brisk daily walk of > 30 min

Setting: supervised cycling sessions at rehabilitation centre and unsupervised at home

Other: not reported

OutcomesMortality and morbidity
ComparisonEducational support but no formal exercise protocol
Country and setting

Italy

Multicentre (15 CR units)

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes reported in methods are reported
Intention-to-treat analysis?Low riskAlthough not stated, it is clear from CONSORT diagram that 2 groups were analysed according to ITT
Incomplete outcome data?Low risk45/45 (100%) exercise training group and 44/45 (98%) available at 6 months' follow-up
Groups balanced at baseline?Low risk"No significant differences were observed between the 2 groups with respect to demographic and clinical data, including age, weight, cause of heart failure, or New York Heart Association functional class. Furthermore, there was no difference between the 2 groups in the medications received during the 6-month period of the study"
Groups received same intervention?Unclear riskNot clearly stated if co-treatments (i.e. cardiovascular medication) in 2 groups were the same

Gielen 2003

MethodsParallel group RCT
Participants

N Randomised: 20 (exercise 10; control 10)

Diagnosis (% of participants):

Aetiology: IHD; DCM

NYHA: Class II 90%; Class III 10%

LVEF: exercise mean 26.1% (SD 6); control mean 24.7% (SD 8)

Case mix: 100% as above

Age (yr): exercise 55 (SD 6); control 53 (SD 9)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: age < 70 yr with CHF (NYHA II to III) as result of DCM or IHD as assessed by cardiac catheterisation. All had clinical, radiological and echocardiographic signs of CHF and an LVEF 40% as assessed by ventriculography and clinically stable condition for > 3 months before enrolment

Exclusion: significant valvular heart disease, uncontrolled hypertension, peripheral vascular disease, pulmonary disease or musculoskeletal abnormalities precluding exercise training

Interventions

Exercise: Total duration: 2 wk inpatient followed by 6 months as outpatient

Aerobic/resistance/mix: aerobic

Frequency: 7 sessions/wk

Duration: 20 min/session

Intensity: 70% symptom limited VO2 max

Modality: cycle ergometers

Setting: supervised sessions at hospital and home-based unsupervised sessions

Other: expected to participate in 1 group training session (walking, callisthenics and non-competitive ball games) of 60 min each wk. Participants were asked to exercise for 20 min/day at home

OutcomesMortality
ComparisonContinued their sedentary lifestyle and remained on their individually tailored cardiac medication supervised by their private physicians
Country and setting

Switzerland

Single centre

Follow-up26 wk (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported in results
Intention-to-treat analysis?Low riskAlthough ITT analysis not reported, groups do appear to be analysed according to original randomised allocation
Incomplete outcome data?Low riskNo loss to follow-up
Groups balanced at baseline?Low risk"Patients in the training group and in the control group showed a significantly reduced left ventricular ejection fraction (training group: 26.1 ±3.1%, control group: 24.7± 2.4%; NS [not significant]) and exercise capacity as determined by peak oxygen uptake (training group: 20.3 ±1.0 ml/kg min, control group: 17.9 ±1.6 ml/kg min; P NS)"
Groups received same intervention?Unclear riskDetails of co-interventions not reported

Gottlieb 1999

MethodsParallel group RCT
Participants

N Randomised: 33

Diagnosis (% of participants):

Aetiology: ischaemic or primary

NYHA: Class II or III

LVEF: exercise 22% (SD 8); control 25% (SD 10)

Case mix: 100% as above

Age (yr): exercise 67 (SD 7); control 64 (SD 10)

Male: exercise 15/16 (94%); control 11/14 (79%); total 87%
White: not reported

Inclusion/exclusion criteria

Inclusion: NYHA Class II-III for at least 3 months and were on stable medications for the past 1 month. All participants were on maximal medical therapy with angiotensin-converting enzyme inhibitors, diuretic and digoxin. All participants had EF < 40% by nuclear ventriculography. No participants had obstructive valvular disease, MI within 3 months, or limitation of exercise secondary to angina or new arrhythmias

Exclusion: not reported

Interventions

Exercise: Total duration: 3 months

Aerobic/resistance/mix: aerobic

Frequency: 3 session/wk

Duration: 30 min

Intensity: Borg 12-13

Modality: bike and treadmill

Setting: supervised sessions at medical centre by a nurse or exercise physiologist

Other: Care provided by specialist HF physician

OutcomesHRQoL (MLWHFQ and MOS SF-36 questionnaire), mortality, morbidity
Comparison

Usual medical care

Other: care provided by specialist HF physicians

Country and setting

USA

Single centre

Follow-up6 months (after randomisation)
NotesMLWHF, MOS SF-36 results not reported for the control group
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported
Intention-to-treat analysis?Unclear riskNot reported
Incomplete outcome data?Low risk

Yes, QUORUM flow diagram reported

Unclear how loss to follow-up, drop-out and cross-over dealt with

Groups balanced at baseline?Low risk "There were no differences at baseline between patients randomised to the control group and those randomised to the exercise program"
Groups received same intervention?Low risk "Medical follow-up of both the control and intervention patients groups was provided by specialized heart failure physicians"

Hambrecht 1995

MethodsParallel group RCT
Participants

N Randomised: 22 (exercise 12; control 10)

Diagnosis (% of participants):

Aetiology: DCM 86%, ischaemic heart disease 14%

NYHA: Class II (55%); Class III (45%)

LVEF: exercise 26% (SD 9); control 27% (SD 10)

Case mix: 100% as above

Age (yr): exercise 50 (SD 12); control 52 (SD 8)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: EF < 40% as assessed by radionucleotide scintigraphy, and a reduced fractional shortening < 30% assessed by echocardiography; willingness to participate in the study for the next 6 months; and a permanent residence within 25 km of the training facility. Physical work capacity at baseline > 25 watts without signs of myocardial ischaemia (i.e. angina or ST segment depression). Clinically stable > 3 months 

Exclusion: exercise-induced myocardial ischaemia or ventricular tachyarrhythmias (higher then Lown Class IVa), valvular heart disease, uncontrolled hypertension, peripheral vascular disease, COPD, and orthopaedic or other conditions precluding regular participation in exercise sessions

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 4-6 sessions/wk

Duration: 10-60 min/session, 1 hr at home

Intensity: 70% VO2max

Modality: cycling, walking, ball games and callisthenics

Setting: first 3 wk supervised hospital-based training; thereafter home-based

Other: none

OutcomesMorbidity and mortality
ComparisonAfter discharge medical therapy continued and participants supervised by private physician
Country and setting

Germany

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods, reported in results
Intention-to-treat analysis?Unclear riskNot reported
Incomplete outcome data?Low riskDrop-outs and clinical events are fully reported for both groups. No imputation undertaken
Groups balanced at baseline?Low risk"There were no significant differences in baseline variables between the training and control groups"
Groups received same intervention?Unclear riskThe exercise group had 3 wk of hospital stay, the control only 3 days. The control group follow-up with private physician. No comment on follow-up of intervention group

Hambrecht 1998

MethodsParallel group RCT
Participants

N Randomised: 20 (exercise 10, control 10)

Diagnosis (% of participants):

Aetiology: IHD 35%; DCM 65%

NYHA: Class II 65%; Class III 35%

LVEF: exercise mean 24% (SD 13); control mean 23% (SD 10%)

Case mix: as above

Age (yr): exercise 54 (SD 9); control 56 (8)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: age < 70 yr, with CHF as a result of DCM or IHD, LVEF < 40%

Exclusion: DM, hypertension, overt atherosclerotic PVD, hypercholesterolaemia, ventricular tachycardia, COPD and primary valvular disease

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 2-6 sessions/day

Duration: 10-20 min/session

Intensity: 70% VO2 max

Modality: bike ergometer

Setting: supervised hospital-based sessions and unsupervised home-based sessions

Other: not reported

OutcomesMortality
Comparison Description: stayed on previous medication, continued sedentary lifestyle, and supervised by their private physicians
Country and setting

Germany

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskIt appears that groups are analysed according to original randomised allocation
Incomplete outcome data?Low riskDetailed description of losses to follow-up and drop-outs reported
Groups balanced at baseline?Low risk"At baseline, patients in the control group did not differ significantly from those in the training group with respect to age, aetiology of heart failure, NYHA functional class, duration of heart failure, LVEF [lett ventricular ejection fraction] or LVEDD [Left Ventricular End Diastolic Diameter]"
Groups received same intervention?Low risk"Patients were on angiotensin-converting enzyme inhibitors (100% in both groups), diuretics (training group 82%, control 70%), and digoxin (training 73%, control 70%, P5NS). Drug treatment did not change between 4 weeks before enrolment and study termination"

Hambrecht 2000

MethodsParallel group RCT
Participants

N Randomised: 73 (exercise 36; control 37)

Diagnosis (% of participants):

Aetiology: IHD 16%; DCM 84%

NYHA: Class I and II 74%; Class III 26%

LVEF: 29% (SD 9)

Case mix: 100% as above

Age (yr): exercise 54 (SD 9); control 54 (SD 8)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: documented HF by signs, symptoms and angiographic evidence of reduced left ventricular function (LVEF < 40%) as a result of DCM or IHD; physical work capacity at baseline > 25 watts, clinical stability >=3 months before study start

Exclusion: significant valvular heart disease, uncontrolled hypertension, DM, hypercholesterolaemia, PVD, pulmonary disease, musculoskeletal abnormalities precluding exercise training

Interventions

Exercise: Total duration: 6-months

Aerobic/resistance/mix: aerobic

Frequency: 6 or 7 sessions/wk

Duration: 10-20/session

Intensity: 70% of peak VO2

Modality: cycle ergometer

Setting: first 2 wk in hospital, remainder home based

Other: plus group sessions 1 hr twice weekly, walking, ball games and callisthenics

OutcomesMortality
ComparisonContinued individually tailored cardiac medications, supervised by their physicians
Country and setting

Germany

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Patients were randomly assigned to either a training group or an inactive group sing a list of random numbers"
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskNot reported
Incomplete outcome data?Low riskQUORUM diagram and details of losses to follow-up reported
Groups balanced at baseline?Low risk"No significant differences were observed between the two groups with regard to demographic or clinical data, including age, weight, LVEF, LVEDD [Left Ventricular End Diastolic Diameter], NYHA or maximum oxygen uptake"
Groups received same intervention?Unclear riskThe co-interventions in the control group not reported

HF ACTION 2009

MethodsParallel group RCT
Participants

N Randomised: 2331 (exercise 1159; control 1172)

Diagnosis (% of participants):

Aetiology: IHD 51%

NYHA: Class II 63%; Class III 35%; Class IV 1%

LVEF: 25% (SD not reported)

Case mix: 100% as above

Age (yr): exercise 59 (SD not reported); control 59 (SD not reported)

Male: 72%
White: 62%

Inclusion/exclusion criteria

Inclusion: LVEF < 35%, NYHA Class II-IV HF for the previous 3 months despite a 6-wk period of treatment, optimal HF therapy at stable doses for 6 wk before enrolment or documented rationale for variation, including intolerance, contraindication, participant preference and personal physicians judgement, sufficient stability, by investigator judgement, to begin an exercise programme

Exclusion: (selected) age <18 yr, co-morbid disease or behavioural or other limitations that interfere with performing exercise training or prevent the completion of 1 yr of exercise training, major cardiovascular event or cardiovascular procedure, including implantable cardioverter defibrillator use and cardiac resynchronisation, within the previous 6 wk

Interventions

Exercise: Total duration: 30 months

Aerobic/resistance/mix: aerobic

Frequency: 3-5 sessions/wk

Duration: 15-35 min/session

Intensity: 60-70% of HR reserve

Modality: cycling or walking

Setting: First 36 sessions were supervised then advised to follow 5 day/wk home-based exercise programme

Other: none reported

OutcomesMortality, hospitalisation, HRQoL (KCCQ), cost-effectiveness
ComparisonUsual care: all participants, regardless of group allocation, received self management educational materials consistent with guidelines of American College of Cardiology and American Heart Association
Country and setting

USA

Multicentre

Follow-upMedian 30.1 months (after randomisation)
NotesAuthors contacted for further details of outcome findings but no information provided
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The trial uses a permuted block randomization scheme stratified by center and by the etiology of the patient's heart failure (ischemic vs nonischemic)"
Allocation concealment (selection bias)Low risk"Patients are randomized at the enrolling centers using an interactive voice response"
Blinding (performance bias and detection bias)
All outcomes
Low riskEvent outcomes were blinded
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low risk 
Incomplete outcome data?Low riskQUORUM diagram and details of losses to follow-up reported
Groups balanced at baseline?Low riskTable 1 of the publication shows 2 groups are well balanced
Groups received same intervention?Low risk"All patients, regardless of group allocation, received self-management educational materials...consistent with guidelines of American College of Cardiology and American Heart Association"

Jolly 2009

MethodsParallel group RCT
Participants

N Randomised: 169 (exercise 84; control 85)

Diagnosis (% of participants):

Aetiology: data not available

NYHA: Class I 6%; Class II 74%; Class III 20%

LVEF: ≤ 40%

Age (yr): exercise 65.9 (SD 12.5); control 70 (SD 12.5)

Male: 75%

White: 85.1%

Inclusion/exclusion criteria

Inclusion: LVEF ≤ 40% on echocardiogram and had a severity of at least NYHA group II in the previous 24 months. They had to have been clinically stable for 4 wk and in receipt of optimal medical treatment and in care of a specialist HF nurse team from 2 acute hospital trusts and 1 primary care trusts and not considered high-risk for a home-based exercise programme

Exclusion: NYHA Class IV, MI or revascularisation within the past 4 months, hypotension, unstable angina, ventricular or symptomatic arrhythmias, obstructive abortive valvular disease, COPD, hypertrophic obstructive cardiomyopathy, severe musculoskeletal problems preventing exercise, and case-note reported dementia or current severe psychiatric disorder

Interventions Exercise: Total duration: 6 months programme progressive with aim that participants achieved the following:
Aerobic/resistance/mix: mix
Frequency: 5 times/wk
Duration: 20-30 min
Intensity: 70% of peak VO2 or Borg 12-13
Modality: aerobic and resistance elements (upper and lower limb exercises)
Setting: first 3 sessions supervised centre-based followed by home-based programme with home-visits by nurse at 4, 10 and 20 wk and telephone support at 6, 15 and 24 wk. Intervention manual provided
Other: specialist HF nurse care
OutcomesHRQoL (MLWHFQ), composite of death, hospital admissions, generic quality of life (EQ-5D)
ComparisonSpecialist HF nurse care
Country and setting

UK

West-midlands, community

Follow-up6- and 12-month follow-up (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"An independent clinical trials unit using a computerized programme undertook randomization after each patient had consented and undergone the baseline tests and questionnaire"
Allocation concealment (selection bias)Low risk"An independent clinical trials unit using a computerized programme undertook randomization after each patient had consented and undergone the baseline tests and questionnaire"
Blinding (performance bias and detection bias)
All outcomes
High risk"…, the nurse undertaking the assessment was blinded to the treatment allocation of the patient, but owing to staffing issues, this occurred in only 62% of participants followed up at 6 months"
Selective reporting (reporting bias)Low risk

All of primary and majority of secondary outcomes described in methods reported

Stated in methods that blood pressure and incremental shuttle walking test were not collected at 12 months

Intention-to-treat analysis?Low risk"...between- and within-group analyses for primary and secondary outcomes at 6 and 12 months were performed according to intention to treat"
Incomplete outcome data?Low risk

Drop-outs and clinical events are fully reported

Outcome available for 161 (95%) participants at 6 months and 157 (92%) participants at 12 months. Non-imputed data reported and sensitivity analysis undertaken to examine impact of missing data

Groups balanced at baseline?Unclear risk"Baseline characteristics were broadly comparable, the exception being that the exercise group was somewhat younger and had higher HADS depression scores and a lower systolic blood pressure"
Groups received same intervention?Low risk"Both groups received specialist heart failure nurse input in primary and secondary care through clinic and home visits that included the provision of information about heart failure, advice about self-management and monitoring of their condition, and titration of beta-blocker therapy"

Jónsdóttir 2006a

MethodsParallel group RCT
Participants

N Randomised: 43 (exercise 21; control 22)

Diagnosis (% of participants):

Aetiology: ischaemic 79%; AF 12%; valvular 7%; hypertension 2%

NYHA: Class II and III

LVEF: exercise 41.5 (SD 13.6); control 40.6% (SD 13.7)

Case mix: as above

Age (yr): exercise 68 (SD 7); control 69 (SD 5)

Male: 79%

White: not reported

Inclusion/exclusion criteria

Inclusion: CHF diagnosis, on CHF medication, clinical symptoms of CHF, clinically stable > 3 months before study entrance, fulfil 1 of the following criteria: previous MI, hospitalised because of CHF, lung oedema and cardiac enlargement on X-ray

Exclusion: chronic obstructive lung disease, orthopaedic disabilities, psychiatric disabilities, cancer, senility and age > 80 yr

Interventions

Exercise: Total duration: 5 months

Aerobic/resistance/mix: mix

Frequency: 2 sessions/wk

Duration: 45 min

Intensity: not reported

Modality: cycling, free weights and elastic rubber-bands (Thera-bands)

Setting: hospital outpatients, supervised by physiotherapists

Other: training group had 3 educational lectures, about nutrition, physical activity and relaxation in addition to the exercise programme

OutcomesRehospitalisation and mortality
ComparisonUsual medical care (continued their previous level of physical activity, which varied from performing little physical activity up to taking a daily walk outdoors)
Country and setting

Iceland

Single centre

Follow-up12 and 28 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskAlthough not reported as ITT analysis, groups did appear to be analysed according to original randomised allocation
Incomplete outcome data?Low riskNo losses to follow-up
Groups balanced at baseline?Low riskTable 2 of the publication suggests 2 groups are well balanced
Groups received same intervention?Low riskYes, both groups appeared to receive same interventions apart from CR intervention

Keteyian 1996

MethodsParallel group RCT
Participants

N Randomised: 40 (exercise 21; control 19)

Diagnosis (% of participants):

Aetiology: DCM 40%; IHD 60%

NYHA: Class II 67.5%; Class III 32.5%

LVEF: 21% (SD 7)

Case mix: 100% as above

Age (yr): 56 (SD 11)

Male: 100%
White: 62.5% (remainder black)

Inclusion/exclusion criteria

Inclusion: NYHA Class II or III, resting EF < 35% measured by echocardiography or gated equilibrium radionuclide angiography and no change in medical therapy >=30 days before randomisation.

Exclusion: AF, acute MI ?3 months, angina pectoris at rest or induced by exercise, current enrolment in another clinical trial, and current participation in a regular exercise programme (at least twice weekly)

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk (rate of perceived exertion 12-14)

Duration: 33 min

Intensity: 60-80% peak HR

Modality: treadmills, stationary cycles, rowing machines and arm ergometers  

Setting:outpatient clinic

Other: none reported

OutcomesMorality and hospital admissions
Comparison

Usual medical care

Participants were instructed to maintain their normal daily activity habits and not to begin an exercise regimen

Country and setting

North America

Single centre

Follow-up6 months (after randomisation)
NotesAuthors contacted for further details of outcome findings but no information provided. Each participant's physician was asked not to change drug regimen during the study, if possible
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Patients were randomly assigned to the exercise group or the control group"
Allocation concealment (selection bias)Unclear risk"Each patient's assignment was sealed in an envelope until completion of the second exercise test"
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low risk"Of the 40 patients entered into the study, only those who also completed the exercise tests at weeks 12 and 24 were considered in the data analysis"
Incomplete outcome data?Low risk"Fifteen patients in the exercise group completed the study. Two patients dropped out because of noncardiac medical conditions (progressive, limiting arthritis in one patient and newly diagnosed cancer in the other) that developed within 1 month of the start of the exercise program. One patient developed atrial fibrillation between week 12 and week 24; 3 other patients stopped exercising for personal reasons before week 12 and refused follow-up testing. Fourteen of the 19 patients in the control group completed the study. Two dropped out for personal reasons and refused follow-up testing, one developed atrial fibrillation between week 12 and week 24, one was hospitalized at week 22 for an acute myocardial infarction, and one died suddenly"
Groups balanced at baseline?Low risk"Among patients who completed the study, no differences in demographic characteristics were seen between the two study groups after randomization"
Groups received same intervention?Unclear riskThe co-interventions in the control group not reported

Klecha 2007

MethodsParallel group RCT
Participants

N Randomised: 50 (exercise 25; control 25)

Diagnosis (% of participants):

Aetiology: IHD 100%

NYHA: Class II: exercise 56%; control 60%; Class III: exercise 44%; control 40%

LVEF: exercise mean 27.4% (SD 5.7); control: 28.5% (SD 5.2)

Case mix: 100% as above

Age (yr): exercise 59.6 (SD 10.2); control 61.2 (SD 9.5)

Male: exercise 80%; control 72%
White: not reported

Inclusion/exclusion criteria

Inclusion: ischaemic HF in NYHA Classes II and III of > 6 months, clinically stable > 6 wk and LVEF < 35%

Exclusion: uncontrolled arterial hypertension; history of major ventricular arrhythmias, acute coronary syndrome, percutaneous coronary intervention or brain event 3 months prior to the study; AF or other arrhythmia making it impossible to perform MRI; previous coronary artery bypass grafting; implantable cardiodefibrillator; permanent pacemaker or the presence of metal parts in the body; signs of osteoarticular dysfunction excluding participation in physical training; DM; COPD and anaemia

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: 25 min/session

Intensity: 80% predicted HR at VO2 max

Modality: cycling

Setting: centre-based

Other: none reported

OutcomesMortality
ComparisonStandard medical care only
Country and setting

Poland

Single centre

Follow-up26 wk (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskNot implicit but numbers used suggest that groups analysed according to randomised allocation
Incomplete outcome data?Low riskNo participants lost to follow-up
Groups balanced at baseline?Low risk"At baseline the groups did not differ significantly in clinical characteristics. The only exception was smoking, the training group consisted of significantly more ex-smokers"
Groups received same intervention?Unclear riskNot reported

Klocek 2005 (Const)

MethodsParallel group RCT
Participants

N Randomised: 42 (exercise group A 14; control 14)

Diagnosis (% of participants): 

Aetiology: ischaemic 100%

NYHA: Class II/III exercise group A 55%; control 100%

LVEF: exercise group A: mean 33.6% (SD 3.6); control 33.2% (SD 3.8)

Case mix: 100% as above

Age (yr): exercise group A 54 (SD 7); control 55 (SD 9)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: stable CHF, LVEF < 40% on echocardiography =<1 month before inclusion, age < 65 yr

Exclusion: moderate or severe pulmonary disease, orthostatic blood pressure fall (> 20 mmHg), or with MI, unstable angina, heart surgery or coronary angioplasty within 3 months prior to inclusion as well as inability to perform bicycle training

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: group A - 20 min/session (4-min constant workload with 1 min rest repeated 5 times)

Intensity: group A - 60% max HR

Modality: cycle ergometer

Setting: CR, outpatient unit under supervision of the physician and rehabilitation specialist

Other: none reported

OutcomesHRQoL (Psychological General Wellbeing Index)
Comparison Description: controls were asked not to change their degree of physical activity during the study
Country and setting

Poland

Single centre

Follow-up26 wk (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear risk"Results of baseline QoL examinations were not known to the patients and their physicians or to the persons performing the randomisation"
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported in results
Intention-to-treat analysis?Low riskIt appears that groups were analysed according to initial random allocation
Incomplete outcome data?Unclear riskNo information presented on loss on loss to follow-up or drop-outs
Groups balanced at baseline?Low risk"At baseline there were no significant differences in between groups in left ventricular ejection fraction and other basic parameters of left ventricular function." "At the start of the study, mean PGWB [Psychological General Wellbeing Index] total index was similar in groups A and B. Controls had lower total index than patients in group B"
Groups received same intervention?Unclear riskDetails of co-interventions not reported although degree of follow-up was stated to be equivalent

Klocek 2005 (Prog)

MethodsParallel group RCT
Participants

N Randomised: 42 (exercise group B 14; control 14)

Diagnosis (% of participants): 

Aetiology: ischaemic 100%

NYHA: Class II/III exercise group B 75%; control 100%

LVEF: exercise group B: mean 34.2% (SD 4.2); control 33.2% (SD 3.8)

Case mix: 100% as above

Age (yr): exercise group B: 57 (SD 8); control 55 (SD 9)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: stable CHF, LVEF < 40% on echocardiography =< 1 month before inclusion, age < 65 yr

Exclusion: moderate or severe pulmonary disease, orthostatic blood pressure fall (> 20 mmHg), or with MI, unstable angina, heart surgery or coronary angioplasty within 3 months prior to inclusion as well as inability to perform bicycle training

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: group B: 25 min/session (exercise workload gradually increased after each 5-min training period to a total of 25 min)

Intensity: group B: up to 75% max HR

Modality: cycle ergometer

Setting: CR, outpatient unit under supervision of the physician and rehabilitation specialist

Other: none reported

OutcomesHRQoL (Psychological General Wellbeing Index)
ComparisonControls were asked not to change their degree of physical activity during the study
Country and setting

Poland

Single centre

Follow-up26 wk (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear risk"Results of baseline QoL examinations were not known to the patients and their physicians or to the persons performing the randomisation"
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported in results
Intention-to-treat analysis?Low riskIt appears that groups were analysed according to initial random allocation
Incomplete outcome data?Unclear riskNo information presented on loss on loss to follow-up or drop-outs
Groups balanced at baseline?Low risk"At baseline there were no significant differences in between groups in left ventricular ejection fraction and other basic parameters of left ventricular function." "At the start of the study, mean PGWB [Psychological General Wellbeing Index] total index was similar in groups A and B. Controls had lower total index than patients in group B"
Groups received same intervention?Unclear riskDetails of co-interventions not reported although degree of follow-up was stated to equivalent

Koukouvou 2004

MethodsParallel group RCT
Participants

N Randomised: 26 (exercise 16; control 10)

Diagnosis (% of participants):

Aetiology: DCM 7%; ischaemic 100%

NYHA: Class II 58%; Class III 42%

LVEF: < 40%

Case mix: 100% as above

Age (yr): exercise 52 (SD 9); control 53 (SD 11)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion:aetiology of CHF was either ischaemic heart disease or DCM. Diagnosis of CHF was mainly based on clinical signs (NYHA Class II and III), radiological findings, and echocardiographically determined EF < 40% and shortening fraction < 30%

Exclusion: recent MI or unstable angina; aortic stenosis; DM; uncontrolled hypertension; musculoskeletal limitations or other contraindications for participating in an exercise training programme; documented exercise-induced severe ischaemia or serious arrhythmias or both

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: mix

Frequency: 3 or 4 sessions/wk

Duration: 60 min/session

Intensity: 50-75% peak VO2

Modality: cycle ergometer, walking or jogging, stair climber and step-aerobics

Plus 'light' resistance exercise (not defined)

Setting: supervised exercise training programme at institution

Other: none reported

OutcomesHRQoL (MLWHFQ and Spritzer Quality of Life Index)
ComparisonNot reported
Country and setting

Greece

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"The psychological tests were assessed from all patients in the first week of admission, before randomization to study groups and the end of the study by the same physician, who was not familiar with the patients"
Selective reporting (reporting bias)Low riskAll outcomes outlined in methods are reported
Intention-to-treat analysis?Low riskNot stated explicitly but appear to analysed according to initial group allocation
Incomplete outcome data?Unclear riskLosses to follow-up, drop-outs not reported
Groups balanced at baseline?Low risk"The two groups of patients participating in the study were similar as regards their clinical data"
Groups received same intervention?Unclear riskNot reported

McKelvie 2002

MethodsParallel group RCT
Participants

N Randomised: 181 (exercise 90; control 91)

Diagnosis (% of participants):

Aetiology: ischaemic 76%; hypertensive 7%; valvular 5%; other 12%

NYHA: Class I-III

LVEF: < 40%

Case mix: 100% as above

Age (yr): exercise 64.8±1.1 (SD 10.5); control 66.1 (SD 9.4)

Male: control 80; exercise 82
White: not reported

Inclusion/exclusion criteria

Inclusion: documented clinical signs and symptoms of HF; LVEF < 40%; NYHA Functional Class I-III; 6-min walk test distance < 500 m

Exclusion: inability to attend regular exercise training sessions; exercise testing limited by angina or leg claudication; abnormal blood pressure response to exercise testing (systolic blood pressure during exercise > 250 mm Hg or diastolic blood pressure response > 15 mm Hg, systolic blood pressure response decrease of > 20 mm Hg after a normal increase or decrease below the resting level); cerebrovascular or musculoskeletal disease preventing exercise testing or training; respiratory limitation (forced expired volume in 1 second, or vital capacity < 60% of predicted, or both); poorly controlled cardiac arrhythmias and any non-cardiac condition affecting regular exercise training or decreasing survival

Interventions

Exercise: Total duration: 9 months (3 supervised, 6 home based)

Aerobic/resistance/mix: mix

Frequency: 2 sessions/wk

Duration: aerobic; 30 min/session

Intensity: aerobic: 60-70% max HR. Resistance: 40% of 1-repetition maximum, with 10 repetitions for the arm exercises and 15 repetitions for the leg exercises, with an increase over 5 wk to an intensity of 60% of 1-repetition maximum and a total of 3 sets of each exercise per session

Modality: aerobic: cycle, treadmill and arm ergometry exercise. Resistance: arm curl, knee extension and leg press performed individually with each limb

After 3 months of supervised training, participants in the exercise group were provided an exercise cycle and set of free weights with instructions to continue training at home 3 times/wk for the remainder of the study

Setting:Supervised for 3 months at rehabilitation centre and unsupervised for 9 months at home

Other: none reported

OutcomesHRQoL (MLWHFQ), mortality, composite of mortality and hospital admission for HF
ComparisonUsual medical care. Control participants were not provided with a formal exercise prescription but were encouraged to continue their usual level of physical activity and were not discouraged from regular physical activity
Country and setting

Canada

Multicentre

Follow-up12 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The predetermined allocation sequence was based on a stream of computer-generated pseudorandom numbers from a uniform distribution stratified by center and with a blocking factor of 4"
Allocation concealment (selection bias)Low risk"Eligible patients were registered in a log and treatment group determined by opening the next sequential study allocation envelope"
Blinding (performance bias and detection bias)
All outcomes
Low risk"Outcome measures were performed in a blinded fashion. Individuals responsible for supervising and recording the results of the outcome measurements were unaware of the patients group assignment"
Selective reporting (reporting bias)Unclear riskAll outcomes described in methods are reported in results
Intention-to-treat analysis?Low riskAlthough ITT analysis not reported, groups do appear to analysed according to original randomised allocation
Incomplete outcome data?Low risk

"In the control group, 83 patients completed 3 months of follow-up (reasons for incompletion: death 3; other problems 4; worsening heart failure 1) and 75 patients completed 12months of follow-up (reasons for incompletion: death 8; withdrawal 2; other problems 3; worsening heart failure 2; refused testing 1)

For the exercise group, 80 patients completed 3 months of follow-up (reasons for incompletion: death 1; withdrawal 5; other problems 1; worsening failure 2; refused testing 1) and 64 patients completed 12 months of follow-up (reasons for incompletion: death 9; withdrawal 6; other problems 7; worsening heart failure 3; refused testing 1)"

No imputation or sensitivity analysis undertaken to assess impact of loss to follow-up

Groups balanced at baseline?Low risk"There were no differences between the control and exercise training groups with respect to age, resting ejection fraction, New York Heart Association class, cause of heart failure, or duration of heart failure"
Groups received same intervention?Unclear risk"All patients were reviewed monthly throughout the study"

Mueller 2007

MethodsParallel group RCT
Participants

N Randomised: 50 (exercise 25; control 25)

Diagnosis (% of participants):

Aetiology: ischaemic; DCM (% not reported)

NYHA: not reported

LVEF: < 40% (% not reported)

Case mix: 100% as above

Age (yr): 55 (SD 10)

Male: 100%
White: not reported

Inclusion/exclusion criteria

Inclusion: CHF documented by clinical, angiographic or echocardiographic criteria; and resting EF < 40%

Exclusion: not reported

Interventions

Exercise: Total duration: 1 month

Aerobic/resistance/mix: aerobic

Frequency: 5 sessions/wk

Duration: 30 min/session cycling, 90 min walking each day

Intensity: Borg 12-14 (60-80% max HR)

Modality: cycling and walking

Setting: indoor cycling sessions were supervised directly by a medical resident and outdoor walking sessions were supervised by exercise physiologists

Other: resided at the rehabilitation centre for 1 month. Programme component also included education and low-fat meals prepared daily by the centre's cook

OutcomesMorbidity and mortality
ComparisonUsual medical care
Country and setting

Switzerland

Single centre

Follow-up6.2 yr (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskOutcomes described in the methods are reported in the results
Intention-to-treat analysis?Low riskITT not stated explicitly. However, groups appear to analysed according to original allocation
Incomplete outcome data?Low risk"Data from one patient in the control group was not available at the two-month evaluation due to refusal to complete testing." "Among subjects in the exercise group, 9 died, and one refused repeat testing. Among patients in the control group, 12 died and two refused repeat testing. Therefore, 14 and 13 patients performed six-year evaluations in the exercise and control groups, respectively." QUORUM diagram reported and detailed text. No imputation undertaken
Groups balanced at baseline?Low risk"No differences were observed between the exercise and control groups initially in clinical or demographic data, including age, height, weight, pulmonary function or medication status"
Groups received same intervention?Unclear risk"Patients in the exercise group resided at the rehabilitation centre for one month. Control subjects received usual clinical care, including verbal encouragement to remain physically active"

Myers 2000

MethodsParallel group RCT
Participants

N Randomised: 25 (exercise 12; control 13)

Diagnosis (% of participants):

Aetiology: ischaemic 100%

NYHA: not reported

LVEF: exercise 31.5% (SD 7); control 33.3% (SD 6)

Case mix: 100% as above

Age (yr): exercise 56 (SD 5); control 55 (SD 7)

Male: 100%

White: not reported

Inclusion/exclusion criteria

Inclusion: MI, diagnosis of HF and stable symptoms, LVEF < 40%

Exclusion: pulmonary disease

Interventions

Exercise: Total duration: 2 months

Aerobic/resistance/mix: aerobic

Frequency: walking: 2 sessions/daily; cycling: 4 sessions/wk

Duration: walking: 1 hr; cycling: 45 min

Intensity: walking: not reported; cycling: 60-70% peak VO2

Modality: walking and cycling

Setting: centre based with supervised by physicians

Other: exercise groups received education sessions and low-fat meals prepared 3 times daily

OutcomesHospitalisation and mortality
ComparisonUsual clinical follow-up
Country and setting

Switzerland

Single-centre

Follow-up2 and 12 months (after randomisation)
Notes"After the initial 2-months exercise training or control period, both groups were encouraged to remain physically active over the subsequent 10 months, although no formal program was implemented"
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskAlthough not explicit, participants appeared to be analysed according to initial random allocation
Incomplete outcome data?Low riskLost to follow-up reported
Groups balanced at baseline?Low risk"No differences were observed between the 2 groups initially in clinical or demographic data, including age, height, weight, resting blood pressure, pulmonary function, ejection fraction, or maximal oxygen uptake"
Groups received same intervention?Low riskYes, both groups appeared to receive same interventions apart from CR intervention

Nilsson 2008

MethodsParallel group RCT
Participants

N Randomised: 80 (exercise 40; control 40)

Diagnosis (% of participants):

Aetiology: ischaemic cardiomyopathy 69%; idiopathic DCM 18%; hypertensive HF 13%

NYHA: Class II 47%; Class III 35%

LVEF: exercise 31% (SD 8); control 31% (SD 9)

Case mix: 100% as above

Age (yr): 70.1 (SD 7.9)

Male: 79%

White: not reported

Inclusion/exclusion criteria

Inclusion: stable CHF and a LVEF < 40% or ≥ 40% with clinical symptoms of diastolic HF

Exclusion: acute MI within 4 wk; unstable angina pectoris; serious rhythm disturbance; symptomatic PVD; severe CPOD, with a forced expiratory vital capacity < 50% of expected measured by spirometry; 6-min walking distance > 550 m; and work load on the cycle ergometer test > 110 watts, significant co-morbidities that would prevent entry into the study due to terminal disease or an inability to exercise (e.g. severe musculoskeletal disorder, advanced valvular disease) or were in long-term care establishments

Interventions

Exercise: Total duration: 4 months

Aerobic/resistance/mix: aerobic

Frequency: 2 sessions/wk

Duration: 50 min

Intensity: 15-18 on Borg scale

Modality: fast walking, side stepping and leg lifts in combination with overhead arm reaches

Setting: hospital outpatient department

Other: 15-30 min counselling for participants in exercise group with CHF nurse (4 hr in total)

OutcomesHRQoL (MLWHFQ) and mortality
ComparisonThe control group was not provided with exercise prescriptions and encouraged to continue their usual levels of physical activity
Country and setting

Norway

Single centre

Follow-up12 months (after randomisation)
NotesAll training sessions were supervised by physiotherapist, a specialist in heart rehabilitation
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"computer-generated table of random numbers"
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"Three physicians and 3 nurses who were blinded to the clinical data and group assignments of the patients carried out all the follow-up tests. Patients were told not to reveal to which groups they belonged"
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low risk"Intention-to-treat analyses were performed"
Incomplete outcome data?Low risk35/40 (88%) exercise training group and 37/40 (93%) control group available at 12 months
Groups balanced at baseline?Low riskTable 1 of the publication suggests no difference between the 2 groups
Groups received same intervention?Low riskYes

Norman 2012

MethodsParallel group RCT
Participants

N Randomised: 42 (exercise 22; control 20)

Diagnosis (% of participants):

Aetiology: ischaemic 50%; non-ischaemic 50%

NYHA: Class II: exercise 64%; control 45%; Class III: exercise 36%; control 55%

LVEF: exercise: mean 33% (SD 7); control: mean 32% (SD)

Age (yr): exercise 57 (SD 12); control 63 (SD 15)

Male: 57.5%

White: not reported

Inclusion/exclusion criteria

Inclusion: age ≥ 21 yr, with HF; orientated to person, place and time; able to speak and read English; resting LVEF ≤ 40% and stable on optimal medical therapy for at least 30 days

Exclusion: clinical evidence of decompensated HF, unstable angina pectoris, MI, coronary artery bypass surgery, biventricular pacemaker < 3 months ago, orthopaedic or neuromuscular limitations preventing participation in aerobic or resistance exercise training, and participation in an aerobic exercise programme during the past 12 months

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: mix

Frequency: aerobic 3 days/wk, resistance 2 days/wk

Duration: aerobic: 30 min/session (30 min warm-up); resistance: 8-10 exercises (upper and lower extremity) performed for 1 set of 10-15 repetitions

Intensity: aerobic: 40-70% HR reserve, or Borg 11-14; resistance: not reported

Modality: aerobic: not reported; resistance: weight machines, free weights or elastic bands based on their exercise performance

Setting: 3 wk: supervised; 21 wk: hospital's wellness centre or home

Other: group meetings that addressed the same education topics as the control group but in addition included information on problem-solving barriers to exercise, relapse management and symptoms experienced during exercise

OutcomesHRQoL (KCCQ), SF-36 and mortality
Comparison

"Attention control"

Instructions to continue with their normal level of activity. No instructions were given to withhold or stop activity

Country and setting

USA

Single centre

Follow-up24 wk (after randomisation)
Notes

Study conducted in 2 sequential 12-wk phases

Phase 1: separate weekly group meetings of both groups during wk 1-3, then separate biweekly meetings during wk 4-12

Phase 2: following the groups for an additional 12 wk without group sessions

Other trial report:

Pozehl B, Duncan K, Hertzog M, Norman JF. Heart failure exercise and training camp: effects of a multicomponent exercise training intervention in patients with heart failure. Heart Lung 2010;39(6 Suppl):S1-13

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
High risk"Research assistants who were blinded to group assignment assisted in some of the data collection. However, because of budget constraints, the investigators who were not blinded to group assignment were also involved in data collection"
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskNot stated but groups analysed according to randomised allocation
Incomplete outcome data?Low riskDue to mortality and drop out KCCQ scores available in 37 patients (88%) at 24 wk
Groups balanced at baseline?Low risk"…no significant difference noted between groups"
Groups received same intervention?Low riskBoth groups received group sessions (attention control) so only difference between groups was exercise based intervention

Passino 2006

MethodsParallel group RCT
Participants

N Randomised: 85 (training 44; control 41)

Diagnosis (% of participants): *

Aetiology: ischaemic 59%; DCM 41%

NYHA: Class I 16%; Class II 69%; Class III 34%

LVEF: training: 35% (SD 9.3); control 32.3 (SD 14.1)

Case mix: 100% as above

Age (yr): exercise 60 (SD 13); control 61 (SD 13)

Male: 87%
White: not reported

Inclusion/exclusion criteria

Inclusion: impaired left ventricular systolic function (EF < 45%) and exercise capacity (peak VO2 < 25 mL/min/kg)

Exclusion: NYHA Class IV, MI or unstable angina < 6 months before the examination, exercise-limiting diseases, and severe pulmonary or renal disease

* baseline data only available for 85 participants

Interventions

Exercise: Total duration: 9 months

Aerobic/resistance/mix: aerobic

Frequency: > 3 sessions/wk

Duration: 30 min/session

Intensity: 65% max VO2

Modality: cycle

Setting: home-based

Other: not reported

Outcomes

HRQoL (MLWHFQ)

Morbidity

ComparisonNot reported
Country and setting

Italy

Not reported

Follow-up9 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskExercise test assessor blinded
Selective reporting (reporting bias)Unclear riskNot reported
Intention-to-treat analysis?Low riskAlthough ITT not stated, groups appeared to be analysed according to original randomisation
Incomplete outcome data?Low riskOutcomes described in methods reported in results
Groups balanced at baseline?Low risk

"The two groups did not differ as to age, gender, NYHA functional class, EF, pharmacologic treatment, or HF etiology (Table 1)"

 

Groups received same intervention?Low risk"Patients in [control] group underwent follow-up visits at the third and ninth month to exclude changes in their usual lifestyle and physical activity"

Pozehl 2008

MethodsParallel group RCT
Participants

N Randomised: 21 (exercise 15; control 6)

Diagnosis (% of participants):

Aetiology: ischaemic 71%; non-ischaemic 29%

NYHA: Class II 39%; Class III 52%; Class IV 9%

LVEF: exercise 27.9% (SD 7.0); control 29.7% (SD 8.7)

Case mix: 100% as above

Age (yr): exercise 66.3 (SD 9.6); control 66 (SD 12.6)

Male: 90%
White: 100%

Inclusion/exclusion criteria

Inclusion: able to speak and read English; stable NYHA Class II-IV no change in medical therapy for 30 days; resting LVEF < 40% measured by echocardiography or gated equilibrium radionuclide angiography; medical diagnosis of HF either ischaemic or non-ischaemic; and standard pharmacological therapy for HF (diuretics, angiotensin-converting enzyme inhibitors and beta-blockers)

Exclusion: participation in a formal exercise programme < 30 days prior to this study; clinical evidence decompensated HF; and any of the following medical conditions: AF, acute MI < 3 months, unstable angina pectoris, end-stage renal disease or orthopaedic impediments to exercise

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: mix

Frequency: 3 sessions/wk

Duration: 30 min aerobic, 20 min resistance

Intensity: 60-85% max VO2, 12-14 Borg scale

Modality: aerobic: treadmill, stationary bike, rower, arm ergometer; resistance: light upper-body exercises (military press, biceps curl and lateral deltoid raises) and lower-body exercises (knee extension, side hip raise and hip extension) with 1-10 lb hand and ankle weights. Wall push-ups, abdominal curl-ups, pelvic tilts, or a combination

Setting: first 12 wk at the hospital and remaining sessions were unsupervised at rehabilitation centre

Other: strategies from social learning theory (goal-setting, feedback and problem-solving guidance) utilised to facilitate, improve adherence to the training programme

OutcomesMortality
ComparisonUsual medical care
Country and setting

USA

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskOutcomes described in methods are reported in results
Intention-to-treat analysis?Low riskAlthough not stated, groups appear to analysed according to initial randomised allocation
Incomplete outcome data?Low risk"One subject in the control group died of myocardial infarction and one subject in the exercise training group was diagnosed with cancer and unable to continue the exercise training."No imputation undertaken
Groups balanced at baseline?Low risk"Subjects did not differ in fatigue or dyspnea by type of HF (ischemic vs. nonischemic) or years since diagnosis of HF (length of time since diagnosis)"
Groups received same intervention?Unclear riskNot reported

Wall 2010

MethodsParallel group RCT
Participants

N Randomised: 19 (exercise 9; control 10)

Diagnosis (% of participants):

Aetiology: not reported

NYHA: mean: exercise 2 (SE 0); control 2.13 (SE 0.13)

LVEF: ≤ 60%

Case mix: as above

Age (yr): exercise 69 (SD 4.44); control 70 (SD 4.05)

Male: 58%

White: 100%

Inclusion/exclusion criteria

Inclusion: 1. a diagnosis of NYHA Class I-III congestive HF, 2. an EF ≤ 60%, 3. systolic dysfunction, 4. physician approval and 5. the ability to complete a minimum of 3 min of a modified Bruce-protocol stress test

Exclusion: failure to meet any of the inclusion criteria, inability to speak English or having noticeable cognitive impairment

Interventions

Exercise: Total duration: 12 months

Aerobic/resistance/mix: aerobic

Frequency: 3 sessions/wk

Duration: > 15 min

Intensity: not reported

Modality: treadmill

Lifestyler® treadmill provided for 1 year of in-home use, 3 supervised exercise sessions at hospital with CR specialist. Weekly in-home exercise visits with CR specialist, Month 1. Monthly in-home exercise visits with CR specialist, Months 2-12. Also received comprehensive disease management programme

Setting: 3 hospital based and the remainder at home

Other: not reported

OutcomesDisease-specific HRQoL (Chronic Heart Failure Questionnaire), mortality
ComparisonComprehensive disease management - by dedicated case manager (participant education on nutrition, medications, and disease management; an oximetry assessment; and constant monitoring of symptomatic changes and disease status
Country and setting

USA

Single-centre

Follow-up12 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported
Intention-to-treat analysis?Low riskAlthough not stated, it is clear from CONSORT diagram that 2 groups were analysed according to ITT
Incomplete outcome data?Low risk

QUORUM flow diagram report suggests 19 were included in the analysis

15 participants (79%) completed final follow-up measures at month 12

Groups balanced at baseline?Low riskTable 3 of the publication suggests there is no difference between the 2 groups (except dyspnoea score)
Groups received same intervention?Low riskBoth groups received comprehensive disease management

Willenheimer 2001

MethodsParallel group RCT
Participants

N Randomised: 54 (exercise 27; control 27)

Diagnosis (% of participants):

Aetiology: ischaemic 80%; non-ischaemic 20%

NYHA: exercise 2.1 (SD 0.7); control 2.4 (0.7)

LVEF: exercise 35% (SD 12); control 38% (SD 10)

Case mix: 100% as above

Age (yr): exercise 64 (SD 5); control 64 (SD 9)

Male: exercise 73%; control 70%
White: not reported

Inclusion/exclusion criteria

Inclusion: 1. 8 points on Boston heart failure criteria; 2. LVEF 0.45 at the most recent radionuclide or echocardiographic examination (not older than 1 year at inclusion) and 3. age 75 yr

Exclusion: 1. change of clinical status or medication (or both) within 4 wk prior to inclusion; 2. MI, heart surgery or coronary angioplasty within 3 months prior to inclusion; 3. inability to perform a bicycle test; 4. exercise-terminating angina pectoris, ST-depressions (> 2 mm in > 1 lead), blood pressure fall (>.10 mm Hg), or arrhythmia (e.g. ventricular tachycardia/fibrillation, ventricular extrasystoles, supraventricular tachycardia > 170 bpm) at the most recent maximal exercise test (including the baseline test); 5. pulmonary disease judged to be the main exercise-limiting factor or peak expiratory flow rate < 50% of the age- and sex-adjusted reference value, or both; 6. NYHA Class IV and 7. clinically significant aortic stenosis

Interventions

Exercise: Total duration: 4 months

Aerobic/resistance/mix: aerobic/interval

Frequency: 2-3 sessions/wk

Duration: 15 min/session increasing to 45 min/session

Intensity: 80% peak VO2, or 15 on Borg score

Modality: cycle ergometry

Setting: group sessions supervised by physiotherapist

Other: none

OutcomesHRQoL (Patient's Global Assessment of Quality of Life), mortality
ComparisonControl participants were asked not to change their degree of physical activity during the active study period. Neither training participants nor controls were instructed regarding physical activity during the 6-month extended follow-up
Country and setting

Sweden

Single centre

Follow-up10 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low riskOutcome assessors blinded. Participants, clinical carers not blinded
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskAlthough ITT not implicit, it appears that groups are analysed according to original randomised allocation
Incomplete outcome data?High riskOutcome available in only 43/54 (80%) participants randomised at 10 months' follow-up. No imputation or sensitivity analysis undertaken to assess effect of loss to follow-up. Authors state that participants available at 10 months' follow-up are representative
Groups balanced at baseline?Low risk"There was no difference between training (n =22) and control (n =27) patients as regards baseline variables"
Groups received same intervention?Low risk"No change in medication allowed during study"

Witham 2005

MethodsParallel group RCT
Participants

N Randomised: 82 (exercise 41; control 41)

Diagnosis (% of participants):

Aetiology: IHD 66%

NYHA: Class II 56%; Class III 44%

LVEF: not reported

Case mix: as above

Age (yr): exercise 80 (SD 6); control 81 (SD 4)

Male: 55%

White: not reported

Inclusion/exclusion criteria

Inclusion: age ≥ 70 yr with clinical diagnosis of CHF according to European Society of Cardiology guidelines, NYHA Class II or III symptoms and evidence of LVSD on echocardiography, contrast ventriculography or radionuclide ventriculography. Evidence of LVSD

Exclusion: uncontrolled AF, significant aortic stenosis, sustained ventricular tachycardia, recent MI, inability to walk without human assistance, abbreviated mental score < 6 of 10, or people currently undergoing physiotherapy or rehabilitation

Interventions

Exercise: Total duration: 6 months

Aerobic/resistance/mix: mix

Frequency: 2-3 sessions/wk

Duration: 20 min

Intensity: Borg 11-13

Modality: walking and wrist/ankle weights

Setting: 3 months; hospital based by senior physiotherapist, 3 months; home-based

After 3 months of supervised training, participants in the exercise group were asked to continue performing exercises at home 2 or 3 times/wk with the aid of video or audio cassette with demonstrations, instructions and music. No face-to-face contact with the physiotherapist during this period

Other: not reported

OutcomesA disease specific health-related quality-of-life (Guyatt chronic heart failure questionnaire), mortality, hospitalisation
ComparisonUsual medical care
Country and setting

UK

Single centre

Follow-up6 months (after randomisation)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"A researcher not otherwise connected with the operation of the study prepared cards contained in numbered, sealed envelopes from computer-generated random number tables"
Allocation concealment (selection bias)Unclear riskNot reported
Blinding (performance bias and detection bias)
All outcomes
Low risk"An experienced research nurse who was blinded to treatment allocation performed all assessments"
Selective reporting (reporting bias)Low riskAll outcomes described in methods are reported in results
Intention-to-treat analysis?Low riskIt appeared that groups were analysed according to initial random allocation from QUORUM diagram
Incomplete outcome data?Low risk75/82 (91%) and 68/82 (83%) available at 3 and 6 months' follow-up, respectively
Groups balanced at baseline?Low riskTable 1 of the publication shows groups are well balanced
Groups received same intervention?Low riskYes, both group appeared to receive usual medical care and the only difference between groups was the exercise intervention

Witham 2012

MethodsParallel group RCT
Participants

N Randomised: 107 (exercise 53; control 54)

Diagnosis (% of participants):

Aetiology: ischaemic 62.6%

NYHA: Class II 79%; Class III 21%

LVEF: not reported

Case mix: as above

Age (yr): exercise 80.4 (SD 5.8); control 79.5 (SD 4.9)

Male: exercise 35%; control 37%

White: 100%

Inclusion/exclusion criteria

Inclusion: age ≥ 70 yr with a confirmed diagnosis of HF due to LVSD (NYHA Class II and III) and a history of symptoms and signs of congestive HF

Exclusion: wheelchair bound, unwilling or unable to give informed, had aortic stenosis with peak gradient > 30 mmHg, experienced sustained ventricular tachycardia or ventricular fibrillation outside the context of an acute MI, and currently (within the past month) had unstable angina or AF with a ventricular rate of > 100/min

Interventions

Exercise: Total duration: 24 wk

Aerobic/resistance/mix: mix

Frequency: 2 sessions/wk

Duration: ≤ 60 min

Intensity: not reported

Modality: home; walking

Setting: hospital and home*

Other: cognitive and behavioural techniques were incorporated into first 8-wk hospital-based rehabilitation. Resistance training with elasticised bands

OutcomesDisease-specific HRQoL (MLWHFQ), HRQoL (EuroQoL-5D), mortality, hospital admission, cost
ComparisonUsual medical care (given a booklet with general advice on diet, exercise and lifestyle). Not discouraged from exercising if they were already in the habit of doing so
Country and setting

UK

Single-centre

Follow-up24 wk (after randomisation)
Notes*8 wk in hospital delivered by experienced physiotherapist, 16-wk home-based (telephoned every 2 wk for 8 wk by the physiotherapists, then monthly for the final 8 wk)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Using off-site telephone randomization service, randomization was performed without stratification and with block sizes between 8 and 16, depending on the size of each planned exercise class"
Allocation concealment (selection bias)Low risk"…the project coordinator passed the participants'details to the research physiotherapist who obtained group allocation, ensuring that the project coordinator remained blind to group assignments"
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskAnalyses were by ITT
Incomplete outcome data?Low risk89/104 (86%) and 87/104 (83%) available for follow-up at 8 and 24 wk, respectively
Groups balanced at baseline?Low riskTable 1 of the publication suggests no difference between the 2 groups
Groups received same intervention?Low riskIt appeared that both groups received same care expect exercise intervention

Yeh 2011

  1. a

    AF: atrial fibrillation; bpm: beats/minute; CBT: cognitive behavioural therapy; CHF: chronic heart failure; CONSORT: CONsolidated Standards of Reporting Trials; COPD: chronic obstructive pulmonary disease; CR: cardiac rehabilitation; DCM: dilated cardiomyopathy; DM: diabetes mellitus; DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EF: ejection fraction; HADS: Hospital Anxiety and Depression Scale; HF: heart failure; hr: hour; HR: heart rate; HRQoL: health-related quality of life; ITT: intention to treat; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEF: left ventricular ejection fraction; LVSD: left ventricular systolic dysfunction; max: maximum; MI: myocardial infarction; min: minute; MOS: Medical Outcomes Survey; MLWHFQ: Minnesota Living with Heart Failure Questionnaire; MRI: magnetic resonance imaging; NYHA: New York Heart Association; PVD: peripheral vascular disease; RCT: randomised controlled trial; SD: standard deviation; SE: standard error; SF-36: 36-item Short Form; VO2: oxygen consumption; wk: week; yr: year.

MethodsParallel group RCT
Participants

N Randomised: 100 (Tai Chi (exercise) 50; education (control) 50)

Diagnosis (% of participants):

Aetiology: ischaemic 54%; non-ischaemic 46%

NYHA: Class I 20%; Class II 63%; Class III 17%

LVEF: mean 29% (SD 8%)

Case mix: 100% as above

Age (yr): exercise 68.1 (SD 11.9); control 66.6 (SD 12.1)

Male: 64%

White: 86%

Inclusion/exclusion criteria

Inclusion: EF < 40% or lower in past 2 yr, stable medical regimen, NYHA Class I-III HF

Exclusion: unstable angina, MI or major surgery in past 3 months; history of cardiac arrest in the past 6 months, history of cardiac resynchronisation therapy in the past 3 months; unstable serious ventricular arrhythmias; unstable structural valve disease; current participation in conventional CR programme; diagnosis of peripartum cardiomyopathy within the preceding 6 months; inability to perform a bicycle stress test; lower extremity amputation or other inability to ambulance owing to condition other than HF; severe cognitive dysfunction (Mini-Mental State Examination score ≤ 24); inability to speak English and regular practice of Tai Chi

Interventions

Exercise: Total duration: 12 wk

Aerobic/resistance/mix: aerobic

Frequency: 2 sessions/wk (for 12 wk) and encouraged to practice at home at least 3 times/wk

Duration: 1 hr class (30 min warm-up)

Intensity: not reported

Modality: Tai Chi movements

1. Wk 2-5: warm-up + raising the power, withdraw and push

2. Wk 6-9: 1 + grasp sparrow's tail, brush knee twist step

3. Wk 10-12: 2 + wave hands like clouds

Participants were given 45-min instructional videotape that outlined the exercises presented in class as an aid to practice

Participants also received same educational pamphlets used in education (control) group with a brief (< 5 min) explanation towards end of 1 Tai Chi session weekly

Setting: centre-based and home-based

Other: none reported

OutcomesHRQoL (MLWHFQ), mortality, hospital admission
Comparison

Education group ('attention control'): nurse practitioner lead education session (same duration and frequency as the Tai Chi group classes)

Participants were asked not to start Tai Chi classes during the study

Country and setting

USA

Multisite

Follow-up12 wk and 6 months (after randomisation)
NotesSingle blind
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The trial uses a permuted block randomization with variable block size to generate treatment assignment"
Allocation concealment (selection bias)Unclear risk"Patients who chose to were randomly assigned to receive a 12-week tai chi exercise program or a heart health education program (attention control)"
Blinding (performance bias and detection bias)
All outcomes
Low risk"We masked all the study staff performing all tests to each participant's group allocation"
Selective reporting (reporting bias)Low riskAll outcomes described in methods reported in results
Intention-to-treat analysis?Low riskAll participants were included in the analysis regardless of their attendance
Incomplete outcome data?Low riskFigure 1 of the publication shows 91% to 96% complete data across HRQoL and exercise outcomes
Groups balanced at baseline?Low risk"The 2 groups were generally similar in demographics, clinical classification of heart disease severity, and rates of comorbidities"
Groups received same intervention?Low riskYes, both groups received comprehensive disease management

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Adamopoulos 2001Relevant outcomes not reported
Alves 2012Relevant outcomes not reported
Barrow 2008< 6 months' follow-up
Belardinelli 2005< 6 months' follow-up
Briffa 2005Not heart failure
Brotons 2009Not exercise-based cardiac rehabilitation intervention
Chang 2005Relevant outcomes not reported
Coats 1992< 6 months' follow-up
Collins 2004< 6 months' follow-up
Corvera-Tindel 2004< 6 months' follow-up
Cowie 2011< 6 months' follow-up
Deng 2006Relevant outcomes not reported
Dingli 2002Relevant outcomes not reported
Edelmann 2011< 6 months' follow-up
Erbs 2003Relevant outcomes not reported
Erbs 2010Relevant outcomes not reported
ExTraMATCH 2004Meta-analysis
Franco 2006< 6 months' follow-up
Gary 2004Relevant outcomes not reported
Gary 2007< 6 months' follow-up
Haykowsky 2007Meta-analysis
Inglis 2006Exercise advice only
Jolly 2007Protocol only
Jónsdóttir 2006b< 6 months' follow-up
Kiilavuori 1999Relevant outcomes not reported
Kitzman 2010< 6 months' follow-up
Kobayashi 2003Relevant outcomes not reported
Korzeniowska-Kubacka 2010Not a randomised controlled trial
Lloyd-Williams 2002Meta-analysis
Meyer 2005Relevant outcomes not reported
Molloy 2006Relevant outcomes not reported
Mudge 2011Protocol
Myers 2001Relevant outcomes not reported
Myers 2002Relevant outcomes not reported
Myers 2007Relevant outcomes not reported
Niebauer 2005aRelevant outcomes not reported
Niebauer 2005bRelevant outcomes not reported
Oka 2000Relevant outcomes not reported
Owen 2000< 6 months' follow-up
Parnell 2002< 6 months' follow-up
Passino 2008Relevant outcomes not reported
Ponikowski 1997< 6 months' follow-up
Pozehl 2003< 6 months' follow-up
Pu 2001Relevant outcomes not reported
Sabelis 2004Relevant outcomes not reported
Sarullo 2006< 6 months' follow-up
Selig 2004< 6 months' follow-up
Senden 2005Relevant outcomes not reported
Smart 2004Meta-analysis
Smart 2007< 6 months' follow-up
Stewart 1998Exercise advice only
Taylor-Piliae 2004Meta-analysis
Tyni-Lenne 2001< 6 months' follow-up
van den Berg-Emons 2004< 6 months' follow-up
van Tol 2006Meta-analysis
Vasiliauskas 2007Relevant outcomes not reported
Wielenga 1998< 6 months' follow-up
Williams 2007Relevant outcomes not reported
Wisløff 2007< 6 months' follow-up
Yeh 2004< 6 months' follow-up
Zhang 2003< 6 months' follow-up
Zhao 2005Relevant outcomes not reported

Characteristics of ongoing studies [ordered by study ID]

ISRCTN86879094

Trial name or titleExercise Training in Diastolic Heart Failure: a Prospective, Randomized, Controlled Study to Determine the Effects of Exercise Training in Patients with Heart Failure and Preserved Ejection Fraction (Ex-DHF)
MethodsRCT
ParticipantsStable symptomatic HF with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology (Paulus 2007))
InterventionsExperimental intervention: individually prescribed, supervised, combined endurance/strength training for 12 months (≥ 3 times/week)
Control intervention: usual care
Outcomes

Primary

  1. Combined outcome score (modified 'Packer score', Packer 2001). This combined score classifies participants as: 1 (worsened), 0 (unchanged) or +1 (improved)

Secondary

  1. Components of the primary endpoint (all-cause mortality, cardiovascular hospitalisations, change in NYHA class, change in global self assessment, change in peak VO2, change in E/e')

  2. Change in echocardiographic parameters of diastolic function (left atrial volume index, Grad of diastolic function, E/e', e', ratio between early (E) and late (atrial - A) ventricular filling velocity (E/A), deceleration time, isovolumic relaxation time), systolic function (LVEF), left ventricular dimensions (left ventricular end diastolic diameter) and structure (left ventricular mass index) after 6 and 12 months

  3. Change in quality of life (SF-36, Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale) after 6 and 12 months

  4. Change in ventilatory efficacy (VE/VCO2) and submaximal exercise capacity (anaerobic threshold, 6-min walk distance) after 6 and 12 months

  5. Change in neurohumoral activation (N-terminal pro brain natriuretic peptide) after 6 and 12 months

  6. Safety and tolerability of training intervention

  7. Gender aspects of all primary and secondary endpoints

Starting date1 September 2011
Contact informationDr Frank Edelmann: fedelmann@med.uni-goettingen.de
NotesTrial still recruiting. Recruitment completion expected in 2014 (author email reply 21 July 2013)

Mudge ongoing

Trial name or titleThe Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF)
MethodsRCT
Participants350 recently hospitalised people with HF with impaired and preserved left ventricular systolic function
InterventionsSupervised exercise training programme and disease management programme vs. disease management programme alone
Outcomes

Primary outcome

  1. proportion of participants who have died or been re-admitted for any cause within 12 months of enrolment

Secondary outcomes at 6 and 12 months

  1. Depressive symptoms measured using the Geriatric Depression Scale and the Hare-Davis Cardiac Depression Scale

  2. Functional status measured using a standardised 6-min walk test, hand-held dynamometry as a measure of grip strength and activities of daily living using standardised questions

  3. Cognitive status using Folstein's Mini-Mental Status Examination

  4. Quality of life using the Assessment of Quality of Life instrument

  5. Sleep quality using the Pittsburgh Sleep Quality Index (in a subset of participants)

  6. Healthcare use including hospital admissions and outpatient and emergency department attendances obtained from the hospital information systems

Starting date

Not reported (150 recruited at time of publication)

"Enrolment will be completed in 2013"

Contact information

Corresponding author: telephone: +61 7 36360854, fax: +61 7 36360272, Email: Alison_Mudge@health.qld.gov.au

Internal Medicine and Aged Care, Royal Brisbane and Women's Hospital, Butterfield St, Herston, Queensland 4029 Australia

NotesTrial completed recruiting. Publication of primary outcomes expected in late 2014 (author email reply 29 July 2013)

NCT00012883

Trial name or titleHome Walking Exercise (HWE) Training in Advanced Heart Failure
MethodsRCT
Participants79 participants with stable HF in the past 3 months
Interventions12-week nurse-managed progressive home walking exercise protocol versus usual activity
Outcomes

Pre- and post-study assessment of:

Functional status (peak VO2 and ventilatory threshold via complete physical examination, 6-min walk test and a Heart Failure Functional Status Inventory), quality of life (Cardiac Quality of Life Index, SF-36, and Dyspnea-Fatigue Index with global rating of symptoms) and autonomic tone (norepinephrine (noradrenaline) and heart rate variability)

Starting dateDecember 2001
Contact informationTeresita E Corvera-Tindel, PhD RN MN, VA Greater Los Angeles Health Care System, USA
NotesContact email sent - no reply

NCT00013221

Trial name or titleExercise Effect on Aerobic Capacity and QOL in Heart Failure
MethodsRCT
ParticipantsAbout 84 participants with left LVEF ≤ 40%. Stable HF
Interventions

Exercise group: 36 weeks of exercise training

Control group: weekly visits with a nurse for 12 weeks

OutcomesAt 12 weeks, exercise capacity (peak VO2) and HRQoL (SF-36)
Starting dateNot reported
Contact informationEileen G Collins, PhD RN, Edward Hines Jr. VA Hospital, USA
NotesContact email sent - no reply (as of 20 September 2013)

NCT01033591

  1. a

    HF: heart failure; HRQoL: health-related quality of life; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; min: minute; RCT: randomised controlled trial; SF-36: 36-item Short Form; VCO2: carbon dioxide consumption; VE: ventilatory efficiency; VO2: oxygen consumption.

Trial name or titleExercise for Patients with Heart Failure in Primary Care: the EFICAR
MethodsRCT
Participants

Inclusion criteria:

  • Age ≥ 18 years

  • Diagnosis of HF on the basis of signs and symptoms (Framingham criteria) and evidence of structural heart alterations detected by echocardiography. Echocardiography scanning guarantees that we are dealing with participants with HF avoiding confounding clinical factors

  • LVEF < 45%

  • NYHA functional Class II-IV, or Stages B and C of the American Heart Association, in a stable situation for at least the previous 4 weeks, with no changes in baseline functional status, no signs of congestion or changes in weight faster than 2 kg in 3 days

  • Receiving optimal treatment with angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, beta-blockers, diuretics and aldosterone antagonists at stable doses for the previous 4 weeks, as long as there are no justified contraindications for their use, and meeting the clinical practice guidelines of the European Society of Cardiology

600 participant target

Interventions

Experimental: exercise supervised exercise + optimised treatment according to the European Society of Cardiology guidelines

No intervention: control optimised treatment according to the European Society of Cardiology guidelines

Outcomes

Primary outcomes:

  1. Change in HRQoL (SF-36 and Minnesota Living with Heart Failure Questionnaire)

Secondary outcomes:

  1. Change in functional capacity (6-min walking test)

  2. Cardiac structural changes (B-type natriuretic peptide)

  3. Muscle strength (dynamometer)

  4. Body composition (fat and muscular weight)

All at 12 months

Starting dateJanuary 2011
Contact informationContact: Dr Gonzalo Grandes
Notes

Zuazagoitia A, Grandes G, Torcal J, Lekuona I, Echevarria P, Gómez MA, Domingo M, de la Torre MM, Ramírez JI, Montoya I, Oyanguren J, Pinilla RO; EFICAR Group (Ejercicio Físico en la Insuficiencia Cardiaca). Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with HF in primary care: The EFICAR study protocol. BMC Public Health. 2010;10:33

Trial still recruiting. Recruitment completion expected June 2014 (author email reply 20 July 2013)

Ancillary