An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial
BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4315 (Published 08 July 2014) Cite this as: BMJ 2014;349:g4315All rapid responses
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We note Prof Thornton’s question on the difference between the trial registration sample size calculation and presented in the paper. This is addressed in the online supplement published with the main manuscript. We would guide readers to this for a full description.
Briefly, an error in the original protocol meant that the recruitment target stated was based on the per-protocol analysis, and therefore accounted for an additional 20% attrition in participant drop out. This used the same power calculation as in the paper. Since the pre-determined analysis was intention to treat the final recruitment target was 380. No interim analysis was performed.
We hope this clears any confusion.
Competing interests: No competing interests
We welcome the comments of Drs Spruit et al, Hopkinson and Dodd et al and are gratified that our work is stimulating constructive debate on these issues within the respiratory community.
As we state in the paper(1), the intervention provided did not represent comprehensive pulmonary rehabilitation (PR) as defined in UK and international guidelines(2, 3). However, we made every effort to provide intensive, progressive physical training during the inpatient segment and a progressive programme, with both written and telephone support to patients after discharge. Exercise prescription and progression followed a set protocol. We believe therefore that the treatment provided was as intensive as possible and practicable within the confines of the UK health system where lengths of hospital stay are brief, short of providing formal supervised PR immediately after discharge.
We believe that the negative findings of the trial support the continued provision of comprehensive, supervised, outpatient post exacerbation PR, as this is of demonstrated efficacy in the population that attend. However, it is our and others(4) experience that as few as 10% of patients accept and take up this offer, raising questions around the generalisibility of the intervention. Despite being in guidelines, there are a number of unanswered questions for post exacerbation PR, most notably a lack of longer term outcome data and a lack of trials comparing early with deferred PR. We would be keen to see the respiratory and rehabilitation communities address these gaps.
We observed clinically large and statistically significant recovery of physical performance and health status in both groups, with a mean improvement of 21% in quadriceps strength and 6.1 point improvement in SGRQ at six weeks. This raises the possibility that some patients may be better served by allowing a period of recovery before engaging in proactive, supervised rehabilitation to maximize potential benefit. As Dodd et al point out and also described by Krumholz , the peri-hospitalisation/ exacerbation period is associated with transient co-morbidities including cognitive impairment(5, 6). This may impair individual patients ability to make informed choices about taking up an offer of early PR and interfere with the delivery of the intervention.
Frailty and advanced disease were particularly evident in our study, with nearly a quarter of the population having a stable state MRC dyspnea grade of 5. We suggest that the limited intervention in our study was due to the specific nature of the hospitalised population. We believe that many of the participants were unable at to exercise intensively enough to induce a physiological response at the time of the intervention. It is likely, however, that there is a sub-group of patients who may respond to an early rehabilitation intervention, and identification of this population is important. It is unknown if this is the same population who self-select for post exacerbation pulmonary rehabilitation.
We hope our work will go some way to provide a richer understanding of how best to serve the diverse needs of this population.
1. Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, et al. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. Bmj. 2014;349:g4315. PubMed PMID: 25004917. Pubmed Central PMCID: 4086299.
2. Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, et al. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013 Sep;68 Suppl 2:ii1-30. PubMed PMID: 23880483.
3. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. American journal of respiratory and critical care medicine. 2013 Oct 15;188(8):e13-64. PubMed PMID: 24127811.
4. Jones SE, Green SA, Clark AL, Dickson MJ, Nolan AM, Moloney C, et al. Pulmonary rehabilitation following hospitalisation for acute exacerbation of COPD: referrals, uptake and adherence. Thorax. 2014 Feb;69(2):181-2. PubMed PMID: 23945168.
5. Dodd JW, Charlton RA, van den Broek MD, Jones PW. Cognitive dysfunction in patients hospitalized with acute exacerbation of COPD. Chest. 2013 Jul;144(1):119-27. PubMed PMID: 23349026.
6. Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. The New England journal of medicine. 2013 Jan 10;368(2):100-2. PubMed PMID: 23301730. Pubmed Central PMCID: 3688067.
Competing interests: No competing interests
When and why did the planned sample size change from 484, as recorded on the trial registration site http://controlled-trials.com/ISRCTN05557928, to 380, as noted in the methods? Were the data inspected during the trial?
Competing interests: No competing interests
A relatively highly selected group of patients with COPD admitted to hospital had a 60% readmission rate and an overall mortality rate of 20% and no benefit (?harm) from early pulmonary rehabilitation. Reasons for study exclusion included greater than four previous admissions and musculoskeletal and neurologic limitations, factors likely to contribute to worse outcomes than the study population, a population that was, to a certain extent, 'cherry picked.'
In short the study failed to benefit the minority of patients who could be expected to have the best outcome. Physicians who wish to effectively care for ALL patients admitted to hospital with COPD must recognize and communicate effectively but with compassion to their patients that COPD is a progressive debilitating disease chartacterized by recurrent hospitalizations and ultimately death. In contrast to efforts to temporarilty reverse the inevitable slope of decline, as described in this study, recognizing that patients have a progressive and ultimately fatal illness has the potential to benefit the majority of patients, not just a small minority.
Competing interests: No competing interests
We read, with great interest, a pertinent study by Greening et al, in which they reported that early rehabilitation during hospital admission for chronic respiratory diseases neither reduced the risk of subsequent readmission nor improved recovery of physical function for over 12 months after the event. Their results suggest that beyond current standard physiotherapy practices, progressive exercise rehabilitation should not be started during the early stages of acute illness.1 The study included only patients with unstable chronic respiratory disorders. We believe that translating this evidence to other populations, especially stable patients, may not be pragmatic. Adherence to current therapy and proper life style changes, including avoiding the risk factors, can benefit patients with chronic respiratory disorders.
Most of the patients with chronic respiratory disorders fall ill frequently because they do not follow a life style that is appropriate for them. As evident from the current trial, severity of disease plays a major role in selecting patients for rehabilitation. Among the patients of chronic respiratory disorders included in the trial, chronic obstructive pulmonary disease (COPD) is particularly affected by age. Since the study includes patients from older age, it becomes difficult to compare age- sensitive pathologies/morbidities. Therefore the study could have been more conclusive if patients selected were matched for age, physical stability, co morbidities, poly pharmacy, etc.
Both the manner of rehabilitation and the corresponding outcomes in South-Asian populations would differ from the West. Available evidence suggests that, patients with stable chronic respiratory disorders may benefit from pulmonary rehabilitation.2-4 A study conducted at London Chest Hospital showed that the initial degree of dyspnoea affects improvement in exercise performance and health status in COPD patients undergoing rehabilitation. 2 A low-cost outpatient and home-based comprehensive rehabilitation program conducted in India shows substantial objective benefits.3 Rehabilitation comprises an important component of the management of chronic respiratory disorders.4
Although the risk of mortality is higher in patients undergoing rehabilitation during acute illness, quality of life has been found to improve in the long term. More importantly, the strongest predictors of mortality, regardless of rehabilitation, include advanced age, obesity, hypertension and diabetes prior to rehabilitation program. Rehabilitation procedures could exacerbate the already prevailing morbidity and mortality.
1. Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, et al. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. Bmj 2014;349:g4315
2. J.A. Wedzicha, J.C. Bestall, R. Garrod, R. Garnham, E.A. Paul, P.W. Jones Eur Respir J 1998; 12: 363–369.
3. Shetty, S., Chakraborty, K., Das, K. M., Ganguly, S., Mandal, P. K., & Ballav, A. A Low Cost Pulmonary Rehabilitation Programme for COPD Patients: Is it any Good? IJPMR October 2006; 17 (2): 26-32
4. Lacasse Y, Goldstein R, Lasserson TJ, et al. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2006(4):CD003793
Competing interests: No competing interests
Based on their findings from a large, prospective, parallel group, single blind, randomized controlled trial, Greening and colleagues conclude that the acute admission because of an exacerbation of a chronic respiratory disease is not the time to enroll patients in a progressive rehabilitation process.1 This conclusion is inconsistent with the British Thoracic Society guidelines on pulmonary rehabilitation in adults, which recommend that patients hospitalized for an exacerbation of COPD should be offered pulmonary rehabilitation at hospital discharge to commence within 1 month of discharge.2 Often, reflection on a single negative study, with a possible reformulation of our pre-set paradigm, does more to advance science than a host of positive studies. The impressively negative trial by Greening et al. may be one of these studies.1
To their credit, the authors’ recruitment and statistical design was of high quality, as were the outcome measures used. So, why is the study of Greening and colleagues negative? The explanation may be quite straightforward: almost half of the patients self-reported poor or no adherence to the 6-week, unsupervised walking based home exercise program in combination with daily neuromuscular electrical stimulation (NMES), three motivational telephone consultations, and a self-management program. Was there an actual increase in aerobic exercise training volume, intensity and/or frequency over time? Were patients able to increase the NMES current intensity? Did some patients over-report their adherence to the unsupervised intervention? An actual performance of the proposed experimental interventions, including a progressive overload, is necessary for patients with chronic respiratory disease to benefit from exercise-based interventions.3-5 Details on the progression of the exercise training modalities during the 6-week intervention period are not reported, except for the significant self-reported increase in mean walking time. Nevertheless, the lack of clinically relevant mean changes in lower-limb muscle function, endurance shuttle walk test and St. Georges’ Respiratory Questionnaire total score following the 6-week intervention suggest that the exercise intervention was insufficient. In turn, it seems unreasonable to expect any health benefit. There may be a threshold intensity, duration and/or comprehensiveness of the intervention (including supervision) initiated in the peri-hospitalization period that is necessary to realize improvements in exercise capacity, health status, and, in turn, health care utilization benefit. The home-based, unsupervised intervention by Greening and colleagues,1 while most probably requiring fewer healthcare resources than a supervised outpatient program, does not seem to meet this standard. Moreover, it seems fair to conclude that patients with a chronic respiratory disease who were recently admitted to the hospital because of an exacerbation are non-adherent to a 6-week, home-based, unsupervised exercise training, and its effects are not clinically relevant. This negative trial, then, although disappointing, may provide the stimulus for more studies defining just what is necessary for an exercise intervention to be effective when initiated in the peri-exacerbation period. Could this be the supervision of the exercise training; a more intensive, ongoing and structured self-management program; demonstrating increased knowledge and skills in managing symptoms and exacerbations; re-evaluating exercise prescription in the more stable phase; longer duration of exercise training; inclusion of high-intensity exercises that result in physiological improvements; promotion of physical activity; and/or a true multidisciplinary approach, including occupational therapy, dietary counseling, and psychosocial counseling?
Even though many patients decline the start of pulmonary rehabilitation following a hospitalization,5-8 about 75% of the (mostly hospital-based, outpatient and/or inpatient) pulmonary rehabilitation programs do enroll patients with chronic respiratory disease during the peri-exacerbation period.9 Should we now stop referring patients with chronic respiratory disease for early, supervised, multidisciplinary pulmonary rehabilitation? No! Greening and colleagues found two similar groups to behave clinically in similar ways. The difference in mortality that began more than five months after the ‘(non)- intervention’ and was identifiable at 12 months may well have been a chance observation. While of concern, the difference does not clearly relate to the early rehabilitation intervention, and may instead relate to other unidentified factors. For example, is it possible that the increased mortality related to an increased patient-perceived sense of self-efficacy for disease management not matched by actual demonstrated skills acquisition? Therefore, to sway opinion and practice based on erroneous assumptions seems inadvisable. Policy makers and payers should start realizing that patients with chronic respiratory disease with a recent hospitalization have an increased risk of hospital readmission and death.10 11 These patients are generally physically inactive, and may suffer from comorbidities, physical impairments and psychological distress.12-15 Further study of the effects of appropriately supervised, state-of-the-art pulmonary rehabilitation programs is still needed in these patients, as they still have a clear indication for early pulmonary rehabilitation.3 We agree with Greening and colleagues that safety monitoring is important both in clinical practice and in future clinical trials. Also, the relative health effects of initiating pulmonary rehabilitation during hospitalizations for disease exacerbations, either alone or in combination with supervised early post-hospitalization rehabilitation, needs to be further elucidated. At this moment, the data from Greening and colleagues cannot be understood as a solid conclusion that ‘progressive pulmonary rehabilitation should not be started at the early stages of the acute illness’,1 but more likely as an indication that an early, unsupervised, home-based exercise training program is not the right care at the right time at the right place for patients with chronic respiratory disease recovering from an acute hospital admission.
Martijn A. Spruit (Department of Research & Education; CIRO+, centre of expertise for chronic organ failure; Horn, the Netherlands; and REVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium; martijnspruit@ciro-horn.nl)
Carolyn L. Rochester (Section of Pulmonary, Critical Care, and Sleep Medicine, Yale University School of Medicine, New Haven, CT, VA Connecticut Healthcare System, West Haven, CT, USA)
Fabio Pitta (Laboratório de Pesquisa em Fisioterapia Pulmonar, Departamento de Fisioterapia, Universidade Estadual de Londrina, Londrina, Paraná, Brazil)
Roger Goldstein (Department of Respiratory Medicine, University of Toronto, Toronto, ON, Canada)
Thierry Troosters (Department of Rehabilitation Sciences, Katholieke Universiteit Leuven, Belgium; and Department of Respiratory Rehabilitation and Respiratory Division, University Hospital Leuven, Leuven, Belgium)
Linda Nici (Pulmonary Diseases, Providence VA Hospital, Providence, RI, USA)
Richard L. ZuWallack (St. Francis Hospital Medical Center, Hartford, CT, USA)
Enrico M. Clini (DU of Medical and Surgical Sciences, University of Modena and Ospedale Villa Pineta, Modena, Italy)
Emiel F.M. Wouters (Dept. of Respiratory Medicine, Maastricht University Medical Center+, Netherlands; and Department of Research & Education; CIRO+, centre of expertise for chronic organ failure; Horn, the Netherlands)
References
1. Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, et al. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. Bmj 2014;349:g4315.
2. Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, et al. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax 2013;68 Suppl 2:ii1-30.
3. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med 2013;188(8):e13-64.
4. Vivodtzev I, Debigare R, Gagnon P, Mainguy V, Saey D, Dube A, et al. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest 2012;141(3):716-25.
5. Clini EM, Crisafulli E, Costi S, Rossi G, Lorenzi C, Fabbri LM, et al. Effects of early inpatient rehabilitation after acute exacerbation of COPD. Respir Med 2009;103(10):1526-31.
6. Johnston K, Young M, Grimmer K, Antic R, Frith P. Frequency of referral to and attendance at a pulmonary rehabilitation program amongst patients admitted to a tertiary hospital with chronic obstructive pulmonary disease. Respirology 2013.
7. Johnston KN, Young M, Grimmer KA, Antic R, Frith PA. Barriers to, and facilitators for, referral to pulmonary rehabilitation in COPD patients from the perspective of Australian general practitioners: a qualitative study. Prim Care Respir J 2013;22(3):319-24.
8. Jones SE, Green SA, Clark AL, Dickson MJ, Nolan AM, Moloney C, et al. Pulmonary rehabilitation following hospitalisation for acute exacerbation of COPD: referrals, uptake and adherence. Thorax 2013.
9. Spruit MA, Pitta F, Garvey C, ZuWallack RL, Roberts CM, Collins EG, et al. Differences in content and organisational aspects of pulmonary rehabilitation programmes. Eur Respir J 2014;43(5):1326-37.
10. Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60(11):925-31.
11. Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010;363(12):1128-38.
12. Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Physical activity and hospitalization for exacerbation of COPD. Chest 2006;129(3):536-44.
13. Spruit MA, Gosselink R, Troosters T, Kasran A, Gayan-Ramirez G, Bogaerts P, et al. Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax 2003;58(9):752-6.
14. Xu W, Collet JP, Shapiro S, Lin Y, Yang T, Platt RW, et al. Independent effect of depression and anxiety on chronic obstructive pulmonary disease exacerbations and hospitalizations. Am J Respir Crit Care Med 2008;178(9):913-20.
15. ten Brinke A, Sterk PJ, Masclee AA, Spinhoven P, Schmidt JT, Zwinderman AH, et al. Risk factors of frequent exacerbations in difficult-to-treat asthma. Eur Respir J 2005;26(5):812-8.
Competing interests: No competing interests
Greening and colleagues’ recent paper is an important contribution to understanding the optimum management of patients with an acute exacerbation of COPD.1 They found that an intervention started during hospital admission with AECOPD, including strength and aerobic training during the in-patient period followed by an unsupervised home walking program, which a little over half of the participants reported they were continuing with at 6 weeks follow up, provided no benefit over usual care. The authors are to be commended for their clear statement; “we did not provide pulmonary rehabilitation as defined in recent guidelines.”1
Pulmonary rehabilitation is a therapeutic intervention which combines a supervised, progressive program of exercise, typically over a period of 8 weeks, with educational interventions to facilitate effective self-management. It has a compelling evidence base for benefit in clinical trials2, in routine clinical practice3 and specifically in the post-exacerbation context.4 As such, it is recognised as one of the highest value interventions in COPD, with a cost per quality adjusted life year gained much lower than that for pharmacological interventions.5
However, the benefits of pulmonary rehabilitation depend upon the comprehensive nature of the intervention. This includes repeated and sustained face to face contact with a multidisciplinary team of health professionals, combined with encouragement to increase exercise levels and reverse physical deconditioning in a supportive group environment. The British Thoracic Society (BTS) has recently produced evidence-based quality standards for pulmonary rehabilitation https://www.brit-thoracic.org.uk/guidelines-and-quality-standards/pulmon... .
Pulmonary rehabilitation provision for patients with COPD and other respiratory conditions remains inadequate and should be a priority for commissioners, particularly in comparison to interventions known to be of low value such as telehealth.6 The clear message from Greening’s paper is that pared down interventions, which do not deliver this comprehensive approach and meet the BTS quality standards, are unlikely to be effective and should not be offered as a substitute for proper, evidence-based pulmonary rehabilitation.
1. Greening NJ, Williams JEA, Hussain SF, et al. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial, 2014.
2. Lacasse Y, Goldstein R, Lasserson TJ, et al. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2006(4):CD003793.
3. Dodd JW, Hogg L, Nolan J, et al. The COPD assessment test (CAT): response to pulmonary rehabilitation. A multicentre, prospective study. Thorax 2011;66(5):425-9.
4. Puhan M, A., Gimeno-Santos E, Scharplatz M, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews 2011; (10). http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD00530....
5. Zoumot Z, Jordan S, Hopkinson NS. Emphysema: time to say farewell to therapeutic nihilism. Thorax 2014. http://thorax.bmj.com/content/early/2014/07/01/thoraxjnl-2014-205667.full
6. Pinnock H, Hanley J, McCloughan L, et al. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial, 2013. 347:f6070 http://www.bmj.com/content/347/bmj.f6070
Competing interests: No competing interests
We find the study of early rehabilitation intervention during acute admissions for chronic respiratory disease [1] both interesting and thought provoking. Whilst the failure to show additional benefit over usual care may in part be explained by the pragmatic decision to use a reduced intensity of rehabilitation, there is also evidence to suggest that COPD patients admitted to hospital are quite different from their stable counterparts, with more severe disease and increased mortality potentially limiting the gains from rehabilitation [2]. We share the authors’ concern regarding the observed increased mortality at 12 months in the intervention group. The data provided appear to indicate worse disease in the intervention group (worse baseline FEV1) which may go some way to explaining this. However, we wonder whether there may be other important patient related factors likely to influence differential mortality rates.
Cognitive impairment has been demonstrated in over 50% of patients hospitalised with an acute exacerbation of COPD, which is unrecognised and associated with increased length of stay and poor health status [3, 4]. It has also been shown to predict mortality in similar populations [5] and is likely to have profound impact on how these vulnerable patients respond to education, supported self-management and pulmonary rehabilitation. Did the authors record or screen for cognitive difficulties in this study? If so, which tool was used and does this help to explain the difference in mortality and response to the intervention?
1. Greening, N.J., et al., An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. Vol. 349. 2014.
2. Suissa, S., S. Dell'Aniello, and P. Ernst, Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax, 2012.
3. Dodd, J.W., et al., Cognitive dysfunction in patients hospitalized with acute exacerbation of COPD. CHEST Journal, 2013. 144(1): p. 119-127.
4. Dodd, J.W., S.V. Getov, and P.W. Jones, Cognitive function in COPD. [Review] [94 refs]. European Respiratory Journal, 2010. 35(4): p. 913-922.
5. Antonelli, I., et al., Drawing impairment predicts mortality in severe COPD.[see comment]. Chest, 2006. 130(6): p. 1687-1694.
Competing interests: No competing interests
Re: An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial
We commend Dr Greening and colleagues on their well conducted and well reported trial of the impact of a home-based rehabilitation programme for those with a recent admission because of an exacerbation of their chronic respiratory disease (1).
The results of this study have implications that extend beyond the management of respiratory disease to the broader rehabilitation community. Access and uptake of rehabilitation for those with acute myocardial infarction, post percutaneous coronary interventions and heart failure, like with chronic respiratory diseases, is highly variable not only in the United Kingdom but also internationally (2,3). Home programmes have played an important role in widening access and participation to cardiac rehabilitation, overcoming patient-reported problems of traditional hospital outpatient or centre-based classes, including issues of accessibility and parking at a local hospital, dislike of groups, and work or domestic commitments (4-6).
The increasing use of home-based cardiac rehabilitation programmes has paralleled the development of a robust evidence base. Our latest Cochrane review analysis includes 17 trials randomising 2172 cardiac patients to receive either centre- or home-based rehabilitation. Two of our review findings are of particular contrast to those of Greening et al.
1. There is no evidence of an increase in all cause mortality in the 3 to 12 month period following home-based cardiac rehabilitation (CR) programmes, when compared to centre programme (see the Figure 1)
2. Home-based cardiac rehabilitation is effective in improving patient outcomes, including blood lipid profile, blood pressure, smoking behaviour as well as generic and disease-specific measures of health-related quality of life. Furthermore, these interventional effects were similar to centre-based programmes.
So why the difference between the results of our Cochrane review and the Greening trial of home-based rehabilitation? As proposed by Greening et al and the accompanying editorial, a likely explanation is the ‘high risk’ status of patients who were admitted to hospital within the previous 48 hrs. Trials in our Cochrane review included individuals of a ‘low risk’ status following an acute MI and revascularisation and excluded those with significant arrhythmias, ischaemia, or heart failure. To date, few trials of cardiac rehabilitation have included patients presenting in the acute setting such as with acute myocardial infarction or unstable angina pectoris. However, an equally important explanation is the uptake and nature of the home-based intervention. In our review, we found levels of patient adherence to home-based cardiac programmes to be high; 67 to 100 percent of patients across trials completing their prescribed rehabilitation. There was evidence of a slightly lower level of intervention drop out in home compared to centre-based programmes (pooled relative risk 1.04, 95% CI: 1.01 to 1.07, I² = 44%). As ‘complex interventions’, rehabilitation programmes should be based on a strong theoretical framework that recognises the key drivers and barriers to patient behaviour change (7). Based on such theoretical principles and using intervention mapping, our NIHR funded Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) programme of research has developed a home based, self-help cardiac rehabilitation programme ('the Heart Failure Manual') for people with heart failure and their caregivers (8, 9).
In closing, it is important that policy makers and guideline developers, such as National Institute of Health and Care Excellence (NICE), do not view the negative results of the Greening trial in isolation but continue to recognise home-based programmes as an important means to improve patient access and uptake to rehabilitation services. Of course, robust trial evidence is needed to support the implementation (or not) of specific home-based rehabilitation interventions for specific patient groups. We look forward to sharing the results of our trial of the Heart Failure Manual in due course.
References
1. Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, Vincent EE, Chimera R, Morgan MD, Singh SJ, Steiner MC. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. BMJ. 2014 Jul 8;349:g4315. doi: 10.1136/bmj.g4315.
2. Hansen TB, Berg SK, Sibilitz KL, Søgaard R, Thygesen LC, Yazbeck AM, Zwisler AD. Availability of, referral to and participation in exercise-based cardiac rehabilitation after heart valve surgery: Results from the national CopenHeart survey. Eur J Prev Cardiol. 2014 May 23. pii: 2047487314536364. [Epub ahead of print]
3. Dalal HM, Wingham J, Palmer J, Taylor R, Petre C, Lewin R; REACH-HF investigators. Why do so few patients with heart failure participate in cardiac rehabilitation? A cross-sectional survey from England, Wales and Northern Ireland. BMJ Open. 2012 Mar 26;2(2):e000787
4. Ades P, Waldmann M, McCann W, Weaver S. Predictors of cardiac rehabilitation participation in older coronary patients. Arch Intern Med 1992;152:1033-5.
5. Andrew GM, Oldridge NB, Parker JO, Cunningham DA, Rechnitzer PA, Jones NL, et al. Reasons for dropout from exercise programs in postcoronary patients. Med Sci Sports Exerc 1981;13:164-8.
6. Dalal HM, Zawada A, Jolly K, Moxham T, Taylor RS. Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis. BMJ. 2010 Jan 19;340:b5631. doi: 10.1136/bmj.b5631
7. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
8. Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) programme. http://www.rcht.nhs.uk/RoyalCornwallHospitalsTrust/WorkingWithUs/Teachin...
9. Greaves CJ, Deighan C, Wingham J, Armitage W, Clark M, Doherty P, Elliot J, Cursiter H, Austin J, Paul K, Taylor L, Taylor RS, Dalal H, on behalf of the REACH-HF investigators. The REACH Heart Failure Manual. Development of a complex, home-based intervention to support self care for people with heart failure. 43rd Annual Scientific Meeting of SAPC, 9th-11th July 2014, University of Edinburgh
Competing interests: No competing interests