Objectives
This is a protocol for a Cochrane Review (intervention). The objectives are as follows:
To determine the effects of pulmonary rehabilitation, using minimal equipment for aerobic and/or resistance training, on exercise capacity, lower limb strength, and quality of life in people with COPD.
Background
Description of the condition
Chronic obstructive pulmonary disease (COPD) is a progressive disease that affects the airways and/or alveoli, causing obstruction to airflow. Primary symptoms include breathlessness, fatigue, and cough (with or without sputum production). Post‐bronchodilator spirometry demonstrates airflow obstruction with forced expiratory volume in one second/forced vital capacity ratio (FEV1/FVC) < 0.70. Classification of the severity of airflow limitation is based on FEV1 as a percentage of predicted according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2017). COPD is estimated to affect 384 million people worldwide, with a global prevalence of 11.7% (95%CI 8.4% to 15.0%) among those aged 30 years or older (Adeloye 2015). COPD is a major cause of morbidity, mortality, and increased healthcare costs globally (Chapman 2006; GOLD 2017); it is estimated that by the year 2030, COPD will be the third leading cause of death worldwide (WHO). The primary risk factor for developing COPD is tobacco smoking, but exposure to smoke from burning of biomass fuel and high levels of air pollution may contribute (GOLD 2017). Symptoms of breathlessness and fatigue are common in people with COPD and are associated with reduced physical activity and deconditioning (Garcia‐Aymerich 2004), along with increased healthcare utilisation (Garcia‐Aymerich 2006).
Description of the intervention
Pulmonary rehabilitation is the most effective therapeutic strategy for improving shortness of breath, health status, and exercise tolerance (McCarthy 2015). Pulmonary rehabilitation has been shown to reduce hospital admissions (Griffiths 2000), as well as hospital re‐admissions after an exacerbation of COPD (Puhan 2016).
The key component of pulmonary rehabilitation is individually tailored exercise training that includes progressive aerobic and resistance training (Bolton 2013; Nici 2006; Ries 2007; Spruit 2013). Many pulmonary rehabilitation programmes take place in hospital gymnasiums, where patients exercise on stationary cycles and treadmills for aerobic training and use weight machines for resistance training.
The intervention to be evaluated in this review is exercise training that does not use equipment such as treadmills, cycle ergometers, arm ergometers, rowing ergometers, or fixed‐weight machines. Examples of minimal equipment exercise programmes designed to improve aerobic capacity are programmes that provide walk training, Tai chi, or low‐resistance elasticised bands. Examples of minimal equipment exercise programmes provided to improve muscle strength are those that use body weight resistance exercises for lower limb resistance training, hand weights for upper limb resistance training, or high‐resistance elasticised bands for both upper and lower limb resistance training.
How the intervention might work
If exercise training within a pulmonary rehabilitation programme is to improve aerobic capacity and muscle strength, exercise must be prescribed with reference to intensity, duration, and frequency of exercise sessions and length of the programme (Spruit 2013). Although limited studies suggests that higher‐intensity training elicits greater training benefits (Zainuldin 2011), a recent review provides some evidence that higher training intensities may prove beneficial (Morris 2016). The physiological responses to aerobic training in people with COPD have been detailed in two seminal studies; Maltais 1997 reported that aerobic exercise training on cycle ergometers (at an intensity between 60% and 80% peak power (Wpeak), for at least 20 to 30 minutes, two to three times per week for eight weeks) increased oxidative enzymes, and Casaburi 1991 showed that such training reduced the lactate produced at an equivalent work rate after training. These changes decreased the stimulus to ventilation, thus reducing breathlessness and increasing endurance capacity (Casaburi 1991).
The physiological responses to loading the muscles during resistance training are increased muscle fibre cross‐sectional area and recruitment of an increased number of motor units through improved neuromuscular co‐ordination, both of which result in increased muscle strength (Higbie 1996).
Growing evidence indicates that aerobic exercise with minimal equipment can achieve the intensities needed to elicit physiological adaptations to training. For example, ground walking at an intensity of 80% of the average six‐minute walk test speed, or 75% of the peak incremental walk test speed, achieved an exercise intensity of approximately 77% of peak oxygen uptake (VO2peak) (Zainuldin 2012; Zainuldin 2015); and Tai chi achieved an exercise intensity of approximately 64% of VO2peak (Leung 2013).
Studies that have used minimal equipment training programmes for aerobic and resistance exercise training, such as ground walking training (Wootton 2014), Nordic walking (Breyer 2010), Tai chi (Leung 2013), and elastic resistance band exercises (Ramos 2014), have shown these methods to be effective in increasing functional exercise capacity and muscle strength, reducing breathlessness, and improving health‐related quality of life among people with COPD.
Why it is important to do this review
High‐level evidence shows effectiveness of pulmonary rehabilitation in improving exercise capacity and health‐related quality of life, while reducing hospital admissions and length of hospital stay (McCarthy 2015; Puhan 2016). Globally, the demand for pulmonary rehabilitation far exceeds the availability of programmes (Brooks 1999; Levack 2012; Wadell 2013; Yohannes 2004). In many parts of the world, it is not always possible for therapists to provide pulmonary rehabilitation in gymnasiums that are well resourced with exercise equipment. If pulmonary rehabilitation programmes that use minimal equipment for exercise training are shown to be effective, this evidence would support establishment of such programmes. Proven effectiveness of minimal equipment programmes would also support rehabilitation (including tele‐rehabilitation) provided within patients' homes or at sites with limited access to equipment. Minimal equipment programmes may enable more widespread delivery of pulmonary rehabilitation to a greater number of people with COPD living in underdeveloped countries or in rural and remote environments. No review has rigorously evaluated the effectiveness of minimal equipment exercise training programmes for people with COPD.
Objectives
To determine the effects of pulmonary rehabilitation, using minimal equipment for aerobic and/or resistance training, on exercise capacity, lower limb strength, and quality of life in people with COPD.
Methods
Criteria for considering studies for this review
Types of studies
We will include randomised controlled trials (RCTs) reported in full text, those published as abstract only, and unpublished data. We will include parallel‐group studies (including those with a cluster design) and will not include cross‐over studies.
Types of participants
We will include adults with a clinical diagnosis of COPD, according to the investigators’ definition. We will include adults with COPD if they are stable or have just had an exacerbation. We will exclude participants who do not have COPD, and, if studies include a mixed population of participants, we will include only data from those with COPD (if they are separately reported or can be obtained from study authors). We will not exclude participants on the basis of comorbidity.
Types of interventions
We will include studies in which the exercise training component of pulmonary rehabilitation uses minimal equipment compared with usual care or sham interventions, or compared with equipment‐based pulmonary rehabilitation programmes. To be included, studies must provide supervised minimal equipment pulmonary rehabilitation programmes that have a component of aerobic training, resistance training, or both, with or without education. Minimum programme duration will be four weeks and supervised sessions will be provided at least twice per week. We will include inpatient, outpatient, community, and home‐based training programmes. We will record the precise nature of the exercise training (intensity, duration, frequency, and mode) when possible. Minimal equipment training group/s will be compared to a control group of no pulmonary rehabilitation, education only, or pulmonary rehabilitation using gym‐based equipment. We will include studies with components of pulmonary rehabilitation other than exercise training, provided they are not part of the randomised treatment (e.g. airway clearance, inspiratory muscle training).
We will structure the comparisons as follows.
Minimal equipment training versus no training, whereby the training will be grouped as aerobic training, resistance training, or combined training.
Minimal equipment training versus equipment‐based training, whereby the training will be grouped as aerobic training, resistance training, or combined training.
Types of outcome measures
Primary outcomes
Functional exercise capacity. This will be determined from field exercise tests (e.g. six‐minute walk test, endurance shuttle walk test, step tests, sit‐to‐stand tests), an endurance cycle ergometer test, or endurance treadmill test
Lower limb strength. This will be determined from maximum repetitions, dynamometers, or isokinetic devices
Health‐related quality of life. This will be determined from total scores on generic or respiratory‐specific quality of life questionnaires
.
Secondary outcomes
Peak exercise capacity. This will be determined from the incremental shuttle walk test or a cardiopulmonary exercise test on a cycle ergometer or treadmill
Health‐related quality of life domains. These will be determined from domains of both generic and respiratory‐specific quality of life questionnaires
Physical activity levels, based on subjective measures such as questionnaires or diaries, or objective measures via activity monitors such as pedometers, accelerometers, or multi‐sensor devices
Psychological status, measured on generic psychological questionnaires or scales such as the Hospital Anxiety and Depression Scale
Healthcare utilisation, measured by hospital admissions and/or length of hospital stay
Symptoms of dyspnoea, measured by dyspnoea scores from a questionnaire or scale
Adverse events/side effects
Reporting in the study one or more of the outcomes listed here is not an inclusion criterion for the review.
We will review primary and secondary outcomes at baseline and immediately following the minimal equipment exercise training intervention or control intervention. If outcomes are also measured over the long term (e.g. 12 months after cessation of exercise training), we will review and report this information separately. We have chosen outcomes that are of clinical relevance and that may be responsive to minimal equipment exercise training.
Search methods for identification of studies
Electronic searches
We will identify studies from the Cochrane Airways Trials Register, which is maintained by the Information Specialist for the Group and contains studies identified from several sources.
Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), through the Cochrane Register of Studies Online (http://crso.cochrane.org/).
Weekly searches of MEDLINE Ovid SP 1946 to present.
Weekly searches of Embase Ovid SP 1974 to date.
Monthly searches of PsycINFO Ovid SP 1967 to date.
Monthly searches of the Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO 1937 to date.
Monthly searches of the Allied and Complementary Medicine database (AMED) EBSCO.
Handsearches of the proceedings of major respiratory conferences.
Studies contained in the Trials Register are identified through search strategies based on the scope of Cochrane Airways. Details of these strategies, as well as a list of handsearched conference proceedings, are provided in Appendix 1. See Appendix 2 for search terms used to identify studies for this review.
We will search the following trials registries.
US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (https://www.clinicaltrials.gov/).
World Health Organization International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/)
We will search the Cochrane Airways Trials Register and additional sources from inception to present, with no restriction on language of publication.
Searching other resources
We will check the reference lists of all primary studies and review articles for additional references.
We will search for errata or retractions from included studies published in full text on PubMed and will report within the review the date this was done.
Data collection and analysis
Selection of studies
Two review authors (JA and SC) will independently screen the titles and abstracts of the search results and will code them as 'retrieve' (eligible or potentially eligible/unclear) or 'do not retrieve'. We will retrieve full‐text study reports of all potentially eligible studies, and two review authors (JA and SC) will independently screen them for inclusion, while recording the reasons for exclusion of ineligible studies. We will resolve disagreements through discussion, or, if required, we will consult a third review author (ZM). We will identify and exclude duplicates and will collate multiple reports of the same study so that each study, rather than each report, is the unit of interest in the review. We will record the selection process in sufficient detail to complete a PRISMA flow diagram and 'Characteristics of excluded studies' tables (Moher 2009).
Data extraction and management
Two review authors (JA and SC) will use a data collection form that has been piloted on at least one study in the review to extract the following study characteristics from included studies.
Methods: study design, total duration of study, details of any 'run‐in' period, number of study centres and locations, study setting, withdrawals, and dates of study.
Participants: N, mean age, age range, gender, severity of condition, diagnostic criteria, baseline lung function, smoking history, inclusion criteria, and exclusion criteria.
Interventions: intervention and comparison.
Outcomes: primary and secondary outcomes specified and collected and time points reported.
Notes: funding for studies and notable conflicts of interest of trial authors.
Two review authors (JA and SC) will independently extract outcome data from included studies. We will note in the 'Characteristics of included studies' tables if outcome data were not reported in a usable way. We will resolve disagreements by reaching consensus or by involving a third person/review author (ZM). One review author (JA) will transfer data into the Review Manager file (RevMan 2014). We will double‐check that data have been entered correctly by comparing data presented in the systematic review against the study reports. A second review author (SC) will spot‐check study characteristics for accuracy against the study report.
Assessment of risk of bias in included studies
Two review authors (JA and SC) will assess risk of bias independently for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve disagreements by discussion or by consultation with another review author (ZM). We will assess risk of bias according to the following domains.
Random sequence generation.
Allocation concealment.
Blinding of participants and personnel.
Blinding of outcome assessment.
Incomplete outcome data.
Selective outcome reporting.
Other bias.
We will judge each potential source of bias as high, low, or unclear and will provide a quote from the study report together with a justification for our judgement in the 'Risk of bias' table. We will summarise risk of bias judgements across different studies for each of the domains listed. We will consider blinding separately for different key outcomes when necessary (e.g. for unblinded outcome assessment, risk of bias for all‐cause mortality may be very different than for a patient‐reported pain scale). When information on risk of bias relates to unpublished data or correspondence with a trialist, we will note this in the 'Risk of bias' table.
When considering treatment effects, we will take into account risk of bias for studies that contribute to that outcome.
Assessment of bias in conducting the systematic review
We will conduct the review according to this published protocol and will justify any deviations from it in the 'Differences between protocol and review' section of the systematic review.
Measures of treatment effect
We will analyse dichotomous data as odds ratios (ORs), and continuous data as mean difference (MDs) or standardised mean differences (SMDs). If data from rating scales are combined in a meta‐analysis, we will ensure that they are entered with a consistent direction of effect (e.g. lower scores always indicate improvement).
We will undertake meta‐analyses only when this is meaningful, that is, if treatments, participants, and the underlying clinical question are similar enough for pooling to make sense.
We will describe skewed data narratively (e.g. as medians and interquartile ranges for each group).
When multiple trial arms are reported in a single study, we will include only the relevant arms. If two comparisons are combined in the same meta‐analysis, we will combine the active arms or will halve the control group to avoid double‐counting.
If adjusted analyses are available (analysis of variance (ANOVA) or analysis of covariance (ANCOVA)), we will use these as a preference in our meta‐analyses. If both change from baseline and endpoint scores are available for continuous data, we will use change from baseline unless we note low correlation between measurements for individuals. If a study reports outcomes at multiple time points, we will use both immediate post‐intervention data and longer‐term data acquired up to 12‐months post intervention.
We will use intention‐to‐treat (ITT) or 'full analysis set' analyses when reported (i.e. those for which data have been imputed for participants who were randomly assigned but did not complete the study) instead of completer or per‐protocol analyses.
Unit of analysis issues
For dichotomous outcomes, we will use participants, rather than events, as the unit of analysis (i.e. number of adults admitted to hospital, rather than number of admissions per adult). However, if a study reports rate ratios, we will analyse them on this basis. We will meta‐analyse data from cluster‐RCTs only if available data have been adjusted (or can be adjusted) to account for clustering.
Dealing with missing data
We will contact investigators or study sponsors to verify key study characteristics and to obtain missing numerical outcome data when possible (e.g. when a study is identified as an abstract only). When this is not possible, and missing data are thought to introduce serious bias, we will take this into consideration in determining the GRADE rating for affected outcomes.
Assessment of heterogeneity
We will use the I² statistic to measure heterogeneity among the studies in each analysis. If we identify substantial heterogeneity, we will report this and will explore possible causes by conducting prespecified subgroup analyses.
Assessment of reporting biases
If we are able to pool more than 10 studies, we will create and examine a funnel plot to explore possible small‐study and publication biases.
Data synthesis
We will use a random‐effects model and will perform a sensitivity analysis by using a fixed‐effect model.
'Summary of findings' table
We will create a 'Summary of findings' table using the following outcomes: functional exercise capacity, lower limb strength, health‐related quality of life, symptoms of dyspnoea and healthcare utilisation. We will use the five GRADE considerations (risk of bias, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of a body of evidence as it relates to studies that contribute data for the prespecified outcomes. We will apply the methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), using GRADEpro software (GRADEpro GDT). We will justify all decisions to downgrade the quality of studies by using footnotes and will make comments to aid the reader's understanding of the review when necessary.
Subgroup analysis and investigation of heterogeneity
We plan to carry out the following subgroup analyses.
Mode of aerobic training. Studies that have the same mode of aerobic training compared to no training (e.g. studies that compare walk training to no walk training; studies that compare Tai chi to no Tai chi).
Mode of resistance training. Studies that have the same mode of resistance training compared to no training (e.g. studies that compare elasticised band resistance training to no elasticised band resistance training; studies that compare free weights resistance training to no free weights training).
Severity of airflow limitation (FEV1% predicted < 50% (severe) vs FEV1 ≥ 50% predicted (not severe)).
Intensity of training (i.e. an intensity prescription at ≥ 70% peak exercise capacity vs < 70% peak exercise capacity, or ≥ moderate vs < moderate symptoms of dyspnoea or fatigue).
We will use the following outcomes in subgroup analyses.
Functional exercise capacity.
Muscle strength.
Health‐related quality of life.
We will use the formal test for subgroup interactions available in Review Manager (RevMan 2014).
Sensitivity analysis
We plan to carry out the following sensitivity analyses after removing the following from the primary outcome analyses.
We will compare results from a fixed‐effect model versus a random‐effects model.
We will exclude studies with high risk of bias (i.e. studies lacking at least two of the following domains: allocation concealment, blinding of outcome assessors, complete outcome data).
We will exclude studies that have not provided aerobic training at an intensity known to produce training effects (e.g. < 50% of peak exercise capacity, symptoms below a 'moderate' level, no indication of training intensity).
History
Protocol first published: Issue 12, 2017
Notes
Authors have made no progress with this protocol in 3 years 7 months. New authors are being sought to take over this protocol.
Acknowledgements
The review authors would like to acknowledge the advice of Dr. Chris Cates from the Cochrane Collaboration in developing this protocol.
Anne Holland was the Editor for this review and commented critically on the review.
The Background and Methods sections of this protocol are based on a standard template used by Cochrane Airways.
This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to the Cochrane Airways Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS, or the Department of Health.
Appendices
Appendix 1. Sources and search methods for the Cochrane Airways Trials Register
Electronic searches: core databases
| Database | Frequency of search |
| CENTRAL (the Cochrane Library) | Monthly |
| MEDLINE (Ovid) | Weekly |
| Embase (Ovid) | Weekly |
| PsycINFO (Ovid) | Monthly |
| CINAHL (EBSCO) | Monthly |
| AMED (EBSCO) | Monthly |
Handsearches: core respiratory conference abstracts
| Conference | Years searched |
| American Academy of Allergy, Asthma and Immunology (AAAAI) | 2001 onwards |
| American Thoracic Society (ATS) | 2001 onwards |
| Asia Pacific Society of Respirology (APSR) | 2004 onwards |
| British Thoracic Society Winter Meeting (BTS) | 2000 onwards |
| Chest Meeting | 2003 onwards |
| European Respiratory Society (ERS) | 1992, 1994, 2000 onwards |
| International Primary Care Respiratory Group Congress (IPCRG) | 2002 onwards |
| Thoracic Society of Australia and New Zealand (TSANZ) | 1999 onwards |
COPD search
1. Lung Diseases, Obstructive/
2. exp Pulmonary Disease, Chronic Obstructive/
3. emphysema$.mp.
4. (chronic$ adj3 bronchiti$).mp.
5. (obstruct$ adj3 (pulmonary or lung$ or airway$ or airflow$ or bronch$ or respirat$)).mp.
6. COPD.mp.
7. COAD.mp.
8. COBD.mp.
9. AECB.mp.
10. or/1‐9
Filter to identify RCTs
1. exp "clinical trial [publication type]"/
2. (randomised or randomised).ab,ti.
3. placebo.ab,ti.
4. dt.fs.
5. randomly.ab,ti.
6. trial.ab,ti.
7. groups.ab,ti.
8. or/1‐7
9. Animals/
10. Humans/
11. 9 not (9 and 10)
12. 8 not 11
The MEDLINE strategy and RCT filter are adapted to identify studies in other electronic databases
Appendix 2. Search strategy to identify relevant studies from the CAGR
#1 MeSH DESCRIPTOR Pulmonary Disease, Chronic Obstructive Explode All #2 MeSH DESCRIPTOR Bronchitis, Chronic #3 (obstruct*) near3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*) #4 COPD:MISC1 #5 (COPD OR COAD OR COBD OR AECOPD):TI,AB,KW #6 #1 OR #2 OR #3 OR #4 OR #5 #7 MeSH DESCRIPTOR Rehabilitation Explode All #8 MeSH DESCRIPTOR Respiratory Therapy Explode All #9 MeSH DESCRIPTOR Physical Therapy Modalities Explode All #10 rehabilitat* or fitness* or exercis* or train* or physiotherap* or (physical* NEXT therap*) #11 #7 or #8 or #9 or #10 #12 #11 AND #4
Contributions of authors
JA Alison: developed and wrote the protocol. Planned contributions to the full review: co‐ordinating the review, undertaking literature searches with support from the Cochrane Airways editorial team, retrieving papers, screening retrieved papers against eligibility criteria, appraising quality of papers, extracting data from papers, writing to study authors for additional information, managing data for the review, entering data into RevMan, analysing and interpreting data, and writing the review.
S Cheng: contributed to development and writing of the protocol. Planned contributions to the full review: retrieving papers, screening retrieved papers against eligibility criteria, appraising quality of papers, extracting data from papers, analysing and interpreting data, and writing the review.
ZJ McKeough: contributed to development and the writing of the protocol. Planned contributions to the full review: acting as a third review author to resolve disagreements, analysing and interpreting data, and writing the review.
Sources of support
Internal sources
-
Faculty of Health Sciences, The University of Sydney, Australia
The review authors are employed at this institution
External sources
The review authors declare that no such funding was received for this systematic review, Other
Declarations of interest
JA Alison: none known.
S Cheng: none known.
ZJ McKeough: none known.
Edited (no change to conclusions)
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