Summary of findings [Explanations]
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Background
Description of the condition
Rheumatoid arthritis (RA) is a chronic inflammatory multisystem disorder of unknown etiology, characterized by symmetric arthritis and destructive synovitis. The prevalence is almost a 2:1 ratio for women to men. The incidence increases as people get older, and approximately 1% of the population is affected worldwide (Matteson 2000). Based on 2003 data from the National Health Interview Survey (NHIS) in United States, an estimated 67 million (25%) adults aged 18 years and older will have doctor-diagnosed arthritis by the year 2030, and 25 million adults (9.3%) will report arthritis-attributable activity limitations (Hootman 2006).
A patient is said to have RA when at least 4 out of the 7 conditions established by the American College of Rheumatology (ACR) have been met: (1) morning stiffness, (2) arthritis of 3 or more joints, (3) arthritis of the hand joints, (4) symmetric arthritis, (5) rheumatoid nodules, (6) serum rheumatoid factor, or (7) radiologic changes (Arnett 1988). This ACR criteria set has sensitivity in the range of 77 to 95 per cent and specificity in the range of 85 to 98 per cent (Bernelot 1992).
Functional ability can be influenced by many factors, some related to rheumatoid disease (tissue inflammation and structural damage) and others involving range of movement, muscle strength, balance, global pain and morning stiffness, but the most important factor is joint tenderness (Plant 2005).
Rheumatoid arthritis is a disease of chronic nature that causes functional disability and it has an economic impact that is disproportional to its prevalence in the community (Emery 2004). Women incur more costs compared to men, because they have more ambulatory care visits and use more complementary medicine. The average costs during the first year after diagnosis for women was USD 11,737 whereas the costs for men were USD 11,403 (Hallert 2006).
Multidisciplinary teamwork is often involved in the treatment of the problems faced by the patient with RA (Tijhuis 2003). These patients may have increased risk of falls and fractures due to osteoporosis. The lower extremity joint impairments may result in either mobility, balance, or postural stability problems, which might increase the risk of falls in patients with RA, but no consensus has been established and further studies are needed (Armstrong 2005).
Description of the intervention
Balance is controlled by sensory input, central processing, and neuromuscular responses. Factors such as loss of muscle strength, range of motion, impaired ambulation and mobility, muscle atrophy, contracture, and exercise intolerance may cause arthritis in lower extremities. This may decrease the motor response efficiency, generating a difficulty in bringing back the center of mass to the normal base of support, which in turn may decrease balance and increase the risk of falls (Aydog 2006).
How the intervention might work
It is necessary that patients maintain their balance while executing multiple tasks on a daily basis (i.e., standing stationary, walking, sitting down and rising from a chair) (Schultz 1992). Therefore, a successful treatment of patients with RA would be controlling the symptoms to prevent further disability (Plant 2005).
Balance training emphasizes the maintenance of balance during visual and perturbation challenges with eyes open or closed, range of motion, and maintaining stability over reduced areas of support and unstable surface (Wolfson 1996). The position of the center of mass in relation to the base of support can be used to measure the balance (Howe 2007). Proprioception can be measured by the joint position sense, and the threshold to detect the passive motion (Willems 2002).
Why it is important to do this review
As people get older, their sensorimotor responses decrease. Patients with RA have a decline in their daily-living activities and function due to the presence of some deformities, and also an increase in the risk or fear of falling. Studies have shown functional improvement in patients with RA after proprioceptive training (McMeeken 1999; Bearne 2002). The aim of this systematic review was to assess the effectiveness and safety of balance training (proprioceptive training) to improve function in patients with rheumatoid arthritis.
Objectives
To assess the effectiveness and safety of balance training (proprioceptive training) to improve functional capacity in patients with rheumatoid arthritis.
The hypotheses are:
- Balance training (proprioceptive training) is better than no treatment.
- Balance training (proprioceptive training) added to a rehabilitation protocol is more effective than a rehabilitation protocol with no balance training (proprioceptive training).
- Balance training is safe for patients with rheumatoid arthritis.
Methods
Criteria for considering studies for this review
Types of studies
All eligible randomised controlled trials (RCT) or controlled clinical trials (CCT) (methods of allocating participants to a treatment which are not strictly random, e.g. date of birth, hospital record number or alternation) evaluating the effects and safety of balance training (proprioceptive training) in patients with RA.
Types of participants
We planned to include all adults (age 18 years and older) of both genders with a diagnosis of RA according to the 1987 American College of Rheumatology (ACR) criteria (Arnett 1988).
Types of interventions
Intervention
- Perturbation training (balance training) is defined as exercises in which participants exercise their muscles against an external force (e.g. unstable platforms) as a consequence of voluntary movement, or in response to an unexpected pertubation or stimulus in order to maintain the body's center of mass.
- The duration of the exercise program should be at least six weeks; exercise frequency twice a week; duration of each exercise session being at least 30 minutes. Trials comparing two or more interventions would also be included.
Controls
- No treatment.
- Another physical intervention.
- Voluntary exercise.
Types of outcome measures
Primary outcomes
The primary measures of effectiveness of balance training included:
- General functional abilities: Health Assessment Questionnaire (HAQ) (Gardiner 1993).
- Gait and other functional measures assessed by six minute walking test, timed up and go (TUG) test or Tinnetti performance oriented mobility assessment (POMA) test.
- Self reported pain (measured with pain scores: Visual Analog Scale (VAS) in cm).
Secondary outcomes
According to outcome measures in RA (OMERACT 1993), the minimum set of valid disease activity variables to be used in clinical trials is: pain, tender joints, swollen joints, function, patient’s opinion, clinician’s opinion and x-rays.
- ACR criteria :1-number of tender joints; 2-number of swollen joints; 3-pain, according to the patient; 4-disease activity, according to the patient; 5-disease activity, according to the consultant; 6-functions in daily life and 7-acute phase reactant (C-reactive protein or blood sedimentation). If a patient improves 20% or more regarding the amount of tender and swollen joints (criteria 1 and 2) and improves 20% or more regarding at least three of the other five criteria, we talk about an ACR 20 response. Improvements of at least 50% or at least 70% are indicated as ACR 50 and ACR 70 responses, respectively (Felson 1995).
- Disease Activity Score 28 (DAS28) (van der Heijde 1990).
- Active knee flexion and extension.
- Joint mobility, preferably measured by the EPM-ROM scale (Ferraz 1990).
- Isometric knee extension.
- Muscle strength measured by dynamometer.
- Patient satisfaction.
- Discontinuations from program/training.
- Adverse events: falls, pain or swelling or both, exercise induced injuries.
Search methods for identification of studies
Electronic searches
We searched the Cochrane Musculoskeletal trials register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4), MEDLINE via PubMed (January 1966 to December 2008), EMBASE (January 1980 to December 2008), Latin American and Caribbean Health Sciences (LILACS) available at http://bases.bvs.br (January 1982 to December 2008), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1982 to December 2008), PEDro (http://www.pedro.fhs.usyd.edu.au/index.html) and Scirus available at http://www.scirus.org/ (inception to December 2008).
Search strategies for randomised controlled trials for PubMed (Lefebvre 2008), EMBASE and LILACS (Castro 1999) were combined with subject-specific search terms (rheumatoid arthritis terms and balance training terms). Complete strategies are shown for The Cochrane Library (Appendix 1), MEDLINE via PubMed (Appendix 2), EMBASE via OVID (Appendix 3), LILACS (Appendix 4), CINAHL (Appendix 5), PEDro (Appendix 6) and SCIRUS (Appendix 7).
Searching other resources
Reference lists of published papers, conference proceedings and papers from congresses and symposiums (2000 to December 2008), major journals (from the year the journal started publication to December 2008) and World Wide Web were searched. We also contacted professional associates to eliminate any possibility of missing information.
Conference Proceedings (2000 to December 2008):
- American College of Rheumatology Annual Scientific Meeting
- Association of Rheumatology Health Professionals Annual Scientific Meeting
- American Academy of Physical Medicine and Rehabilitation Annual Assembly
- American Physical Therapy Association
- Canadian Physiotherapy Association Annual Congress
Major Journals (from the year the journal started publication to December 2008):
- Arthritis and Rheumatism
- Arthritis Care and Research
- Journal of Clinical Rheumatology
- Rheumatology
- Australian Journal of Physiotherapy
- Physiotherapy Canada
- Physical Therapy
- Archives of Physical Medicine and Rehabilitation
- Physiotherapy
Data collection and analysis
Selection of studies
Two review authors (KNGS and AMI) independently screened titles and abstracts obtained through the search strategies to select trials for inclusion.
Data extraction and management
We planned that when a study fulfilled the inclusion criteria, data concerning methodological issues, characteristics of participants, interventions and outcome measures would be independently extracted using a standard extraction form and the review authors would not be blinded to studies' authors, institutions or journals of publication.
Assessment of risk of bias in included studies
In order to ensure that variation was not caused by systematic errors in the study design we planned that two independent review authors (KNGS) and (AMI) would assess the methodological quality of the selected trials using the following criteria (Higgins 2008):
- Sequence generation
- Was the allocation sequence adequately generate?
- Allocation concealment
- Was the treatment allocation concealed?
- Blinding of participants, personnel and outcome assessors
- Was the patient blinded (if the nature of intervention is compatible with this method)?
- Was the care provider blinded (if the nature of intervention is compatible with this method)?
- Was the outcome assessor blinded?
- Incomplete outcome data
- Were incomplete outcome data adequately addressed?
- Selective outcome reporting
- Are reports of the study free of suggestion of selective outcome reporting?
- Other sources of bias
- Was the study apparently free of other problems that could put it at a high risk of bias?
The following dimensions and criteria were used in a standard way adopted from the Cochrane Handbook:
All items of methodological quality were scored as "yes", "unclear" or "no", meaning "low risk of bias", "moderate risk of bias" and "high risk of bias", respectively.
Grade the strength of evidence
Grading of the evidence would be done using the GRADEpro software (Brozek 2008; Schünemann 2008a).
Measures of treatment effect
Dichotomous data
For dichotomous data, relative risks (RR) and 95% confidence intervals (CI) would be estimated according to the intention-to-treat principles. For dichotomous outcomes, the weighted absolute risk difference would be calculated using the risk difference (RD) statistic in RevMan. RR - 1 calculates the weighted relative percentage change (Schünemann 2008b). The number needed to treat (NNT) would be calculated from the control group event rate (unless the population event rate is known) and the relative risk using the Visual Rx NNT calculator (Cates 2003). They would be presented in the results as well as in the "Summary of findings table".
Continuous data
Continuous outcomes would be pooled as weighted mean differences (WMD), when trials using the same scale are pooled. For continuous outcomes pooled on different scales, the standardized mean difference (SMD) would be used. Continuous data would be presented as "endpoint" or "change from baseline", depending on the availability of data from primary studies (Schünemann 2008c). We would also make available the 95% confidence intervals (95% CI) around the effect estimates.
Regardless of whether data were continuous or dichotomous, the fixed-effect model would be preferred for pooled data, but the random-effects model would be used when heterogeneity was present.
Unit of analysis issues
The analysis of studies with non-standard designs would be considered if in each study:
- groups of individuals were randomised together to the same intervention (e.g. cluster-randomised trials);
- individuals had undergone more than one intervention (e.g. in a cross-over trial, or simultaneous treatment of multiple sites on each individual);
- there were multiple observations for the same outcome (e.g. repeated measurements, recurring events, measurements on different body parts).
Dealing with missing data
For missing data (e.g. publication bias, outcome not measured, lack of intention-to-treat analysis, attrition from the study) we planned to:
- whenever possible, contact the original investigators to request missing data;
- make explicit the assumptions of any methods used to cope with missing data: e.g. that the data were assumed to be missing at random, or that missing values were assumed to have a particular value such as a poor outcome;
- perform sensitivity analyses to assess how sensitive results are to reasonable changes in the assumptions that are made;
- address the potential impact of missing data on the findings of the review in the Discussion section.
Assessment of heterogeneity
Heterogeneity would be assessed using the Chi
Assessment of reporting biases
To assess publication bias, we planned to use a funnel plot in RevMan.
Data synthesis
In the absence of significant heterogeneity, a fixed-effect model would be used. However, if significant heterogeneity was demonstrated, a random-effects model would be used for analysis. Where available, the analyses would be based on intention-to-treat data from the individual studies. The data from included trials would be combined in a meta-analysis if they were sufficiently homogeneous, both clinically and statistically.
Subgroup analysis and investigation of heterogeneity
Subgroup analysis
Subgroup analysis would be performed according to methodological quality of primary studies ("yes" or "no", meaning "low risk of bias" and "high risk of bias", respectively) as well as according to clinical aspects (age range, level of functional capacity). Subgroup analysis would also be performed as regards the treatment particularities (frequency, duration, type) (Deeks 2008a).
Sensitivity analysis
Sensitivity analyses would be indicated to assess all included studies, in relation to the different levels of methodological quality (e.g. "yes" or "no", meaning "low risk of bias" and "high risk of bias", respectively), clinical heterogeneity and others (Deeks 2008b).
Results
Description of studies
See: Characteristics of excluded studies.
The electronic search identified 864 studies. From this search, 17 studies (full-text) were retrieved for further investigation. As we did not find any studies investigating the effects of balance training alone or in combination with other therapies in patients with rheumatoid arthritis, it was not possible to include any data regarding the chosen topic in this systematic review. Characteristics of excluded studies: intervention was directed at strength training; duration of intervention less than six weeks; balance training less than 30 minutes per exercise session; conditioning training (swimming, cycling, running or jogging); progressive dynamic strength training (Figure 1).
 | Figure 1. Flow chart: Selection of studies. |
Risk of bias in included studies
No studies met the review's inclusion criteria.
Effects of interventions
See: Summary of findings for the main comparison Balance training (proprioceptive training) for rheumatoid arthritis
No studies met the review's inclusion criteria.
Discussion
Rheumatoid arthritis is a disease that causes functional impairment in patients. For the purpose of improving quality of life in these patients, new types of treatments were introduced. Patients with RA used to be treated only with medication and rest. However, it was observed that this type of approach contributed to a decrease in muscle strength, range of motion, and consequently, a decrease in functional capacity. Recently, the practice of physical exercises has been implemented yielding excellent results on functional capacity.
Due to the chronic inflammatory process, people's joints may present with proprioceptive impairments, which may, consequently, affect the afferent signal generated by the mechanoreceptors present at the joint level (Ferrell 1992). Arthritis is associated with several factors that may affect the quality of sensory information from the lower limbs. Factors such as loss of muscle strength, loss of range of motion, instability of weight-bearing joints, impaired ambulation, impaired mobility, muscle atrophy, contracture, deconditioning, and exercise intolerance, may also disrupt the relation between automatic postural responses and sensory information. This could lead to difficulties in maintaining postural balance, which may increase risk of falls (Aydog 2006). Any deficits in one of those systems (somatosensorial, visual and vestibular system) would decrease a patient's ability on balance, gait and postural control, which would affect their functional capacity.
Balance training in combination with resistance exercises varying from low to high intensity, have been described for rehabilitation of athletes, patients undergoing orthopedic surgery, with rheumatoid arthritis, osteoarthritis, elderly and others.
Lin 2009 investigated functional efficacy comparing two different non-weight-bearing exercise regimens: proprioceptive training and strength training, in patients with knee osteoarthritis. They evaluated 108 patients who were randomly assigned to proprioceptive training, strength training or no exercise (control) groups. They concluded that exercise interventions were effective in improving pain, function, walking speed on different terrains, and knee strength in patients with knee OA. Proprioceptive training was found to be superior in enhancing neuromuscular function (joint reposition sense and walking speed) and strength training was demonstrated to be more effective in improving knee extension strength and functional performance.
Teixeira 2009 conducted a single blind randomized controlled clinical trial in patients with osteoporosis. Fifty patients were assigned to each group: proprioceptive and strength training, and no exercise (control) groups. They concluded that progressive quadriceps strength training combined with proprioceptive training is effective in increasing quadriceps strength, improving static and dynamic balance, and increasing speed of the motor responses; therefore, improving the performance of daily activities and reducing the frequency of falls in women with postmenopausal osteoporosis.
Some authors showed that the strengthening of arms and legs by aerobic exercises (low and moderate intensity) and dynamic exercises (swimming, walking) is recommended for improvement of symptoms caused by rheumatoid arthritis (Bilberg 2005; Ekdahl 1990; Eversden 2007; Häkkinen 2001).
Other systematic reviews about exercise for patients with RA evaluated the effectiveness of other types of rehabilitation such as balneotherapy (Verhagen 2004) and Tai Chi (Han 2004). Both of them had a tendency to favour the intervention in improving functional capacity.
A systematic review of 34 studies, with 2883 patients investigated the effectiveness of exercises for improving balance in older people. They showed significant benefits of a variety of exercises (low resistance exercises against gravity, using theraband for legs and trunk, reaching, weight shifting, marching on spot, single and double limb balance, coordination, flexibility, balance exercises designed to challenge the visual system, strengthening exercises of lower limbs, walking and cycling on a static cycle) (Howe 2007). However, the effects and safety of balance exercises (proprioceptive training) in RA have to be further investigated in future studies.
Authors' conclusions
Implications for practice Although there are a few publications showing that balance training, either in conjunction with other exercise programs or alone, has improved functional capacity in other populations, we were not able to provide any evidence to support the application of balance exercises (proprioceptive training) alone in patients with RA. |
Implications for research Further randomised controlled trials are required to evaluate the effectiveness and safety of balance exercises (proprioceptive training) alone in patients with RA. All future randomised trials must follow the methodological items of the CONSORT statement. Greater attention should be given to methodological design including sample power, randomisation, blinding of clinicians (where appropriate), outcome assessors and statistical analyses. Future studies should consider the entire description of the proprioceptive training protocol and criteria to progress with the exercises. The suggested protocol could include some balance training tasks such as: feet together, semi and tandem position, one leg stance, unstable platforms or foams, eyes opened and closed; in addition to some coordination and agility training tasks such as: shuttle walk, tandem walk, cross-over walk, side-to-side walk, figure of eight, and carioca. Furthermore, muscle strength assessment of the lower extremity would be important for understanding the influence of muscle weakness on balance control in patients with RA. |
Acknowledgements
The review authors would like to acknowledge the Cochrane Musculoskeletal Group personnel, Louise Falzon (trial search coordinator) and Elizabeth Tanjong Ghogomu (Assistant Managing Editor), as well as the Brazilian Cochrane Center personnel (Regis Andriolo, Brenda Nazaré and Mauro Ishioka) for their assistance with the present review. In addition, we would like to acknowledge Nina Brodin for providing further information about her study.
Data and analyses
This review has no analyses.
Appendices
Appendix 1. The Cochrane Library search strategy
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Appendix 2. MEDLINE search strategy
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Appendix 3. EMBASE search strategy
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Appendix 4. LILACS search strategy
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Appendix 5. CINAHL search strategy
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Appendix 6. PEDro search strategy
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Appendix 7. SCIRUS search strategy
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What's new
Last assessed as up-to-date: 27 June 2009.
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History
Protocol first published: Issue 1, 2009
Review first published: Issue 5, 2010
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Contributions of authors
Kelson Nonato Gomes da Silva (KNGS) was responsible for conception, design and coordination of this protocol.
KNGS was responsible for the search strategy, in collaboration with trial search coordinator Louise Falzon of the Cochrane Musculoskeletal Group.
KNGS ran searches and, in collaboration with Aline Mizusaki Imoto (AMI), screened search results, obtained papers, appraised quality of studies, and extracted data.
KNGS and Aline Mizusaki Imoto (AMI) were responsible for data management for the review. Disagreements were resolved in consultation with Maria Stella Peccin (MSP).
Gustavo JM Almeida was responsible for reviewing English writing and incorporating the body of the review.
Virgínia Fernandes Moça Trevisani was responsible for the clinical content of the study and final approval of the review.
Alvaro N Atallah reviewed the methodology and gave final approval of the review in agreement with Virgínia FM Trevisani.
Declarations of interest
None known.
Sources of support
Internal sources
- Brazilian Cochrane Centre, Brazil.
External sources
- No sources of support supplied
Index terms
Medical Subject Headings (MeSH)
Arthritis, Rheumatoid [*rehabilitation]; Exercise Therapy [*methods]; Postural Balance [*physiology]; Proprioception [*physiology]
MeSH check words
Humans