Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of death across the world and will become increasingly common with an aging population. Pulmonary rehabilitation (PR) is an evidence-based, nonpharmacological intervention for individuals with COPD, targeting the secondary impairments of the disease. Although the benefits of participation in PR are well established, improvements in exercise tolerance and health status typically deteriorate following discharge. Challenges with long-term adherence to recommended exercise regimens are thought to explain much of this decline. Therefore, we developed a community-based exercise maintenance program for patients with COPD following discharge from PR. Objectives This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Methods Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Results Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Discussion Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best to implement them. If effective, the intervention represents an opportunity to transition patients from institutionally-based rehabilitative management to community-based care. The results of the process evaluation will contribute to the science of translating evidence-based programs into regular practice.


June 28, 2013
Dr. Dina BROOKS Department of Physical Therapy 160-500 University Avenue Toronto, Ontario M5G 1V7 Dear Dr. BROOKS: We are pleased to inform you that the Canadian Institutes of Health Research (CIHR) has approved your recent application entitled "Randomized controlled trial of a community-based exercise program for preventing functional decline among individuals with chronic obstructive pulmonary disease". If you are receiving this letter through ResearchNet, your Authorization for Funding will follow in the mail otherwise it is enclosed in this package.
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Once again, congratulations and I wish you success in your research. This is a protocol for a randomized, controlled trial of a community-based exercise program in patients with COPD. The investigators will randomize 100 subjects with COPD who have completed the pulmonary rehab programme at Westpark Hospital in Toronto. Subjects will be randomized to a community-based exercise program to be done in one of 3 community centers in Toronto at least twice per week for one year.
The primary objectives are to evaluate the effects over one year of a community-based maintenance exercise program on functional exercise capacity as measured by six-minute walk distance (in individuals with moderate to severe COPD who have completed a course of pulmonary rehabilitation).
The program will be supervised by fitness instructors, and a case manager will provide remote supervision. This will be a single-blind trial, and there will be concealment of randomization and the outcome assessor will remain unaware of the patient group allocations. The primary outcome will be the 6 minute walk test results. Quality of life as assessed by the Chronic Respiratory Disease Questionnaire will be a secondary outcome, a cost-effectiveness assessment is also built into the analysis protocol.
Review of the team: The principal applicant is a PhD researcher who is a Professor at University of Toronto Dept of Physical Therapy. Dr. Brooks is an accomplished researcher with an interest in exercise and rehabilitation of patients with chronic lung disease. She has over 80 publications in the past 5 years, many in high-impact journals. She supervises numerous graduate students. The PI is an experienced accomplished investigator who is clearly capable of running this study. Her co-applicant Dr. Roger Goldstein is a senior clinical researcher with expertise in pulmonary rehabilitation. Dr. Goldstein will be able to provide adequate access to patients, and will provide mentorship for the study team. Dr. Gordon Guyatt is on the team and he will provide biostatistical and methodologic support. The team is strong and able to carry out the proposed study.
Strengths of the Application: 1) The researchers are studying an important clinical problem. The applicants have convincingly shown that although individuals with COPD demonstrate marked improvements following participation in a formal rehabilitation program, they often experience a decline in function over the subsequent months. Interventions would be required to keep these patients functioning at a high level.
2) The team is very strong and capable of completing this study.
3) The study will include a formal economic analysis of the exercise intervention strategy. The measure of effectiveness for the economic analysis will be quality-adjusted life-years (QALYs) and the relevant utility weights will be obtained from the patients. The two groups will be compared in terms of the mean utility-weighted follow-up time, the difference being the gain in expected QALYs per patient associated with the maintenance intervention.
4) The applicants have results from a previous study they conducted which showed that enhanced follow-up (without a specific exercise program) did not improve outcomes in patients who had completed a standard pulmonary rehab program, because of non-adherence to home exercise. Their previous study provides rationale and justification for the current application.
5) The applicants have developed a post-rehabilitation community-based exercise program in partnership with the City of Toronto, Parks, Forestry and Recreation Division and piloted the program at a single community site. They have preliminary results which demonstrate the feasibility of the program in 29 patients (who have all been treated with the intervention), with sustained significant improvements in 6MW distance and HRQL 6-months and 1-year following PR. They have provided the pilot study results in detail in section 2.19 of the revised grant.
6) The applicants have responded to the previous two courses of reviews and they have appropriately addressed previous methodologic limitations. Specifically they have justified their between group difference in 6 MW test (the primary outcome) of 54 m. From their pilot data it appears that at 12 months subjects improved their 6MW distance by approximately 35 meters. They expect subjects in the control group to decline by as much as 60 meters over 12 months. Therefore the between group difference of 54 m (the MCID) should be achievable with the intervention, and the sample size is appropriate.
Weaknesses of this application : None are apparent.
Overall assessment: This is a strong grant, by a strong team. They are studying an important problem; it is well known that benefits of pulmonary rehab are not sustained once patients exit their program, because of non-adherence to home exercise. The intervention described in this protocol, a community-based exercise program, has the potential to extend the long-term benefits of exercise/rehab to the COPD population. The authors have presented pilot data that shows that they can deliver the intervention, and this pilot data suggests feasibility of the study. The authors have improved their protocol significantly compared to the previous 2 submissions. I am in favour of funding the current protocol.

Synopsis of the Proposal
This is a resubmission of a proposal previously reviewed by the Respiratory Systems Committee and received a very high score.
This novel and very clinically relevant proposal addresses the effect of a community based exercise program on the exercise tolerance and health-related quality of life in individuals with COPD. The applicants propose to randomize subjects in a "blinded" manner to either standard care, or a 12 month exercise program supervised by a qualified fitness instructor employed by the Toronto Parks and Recreation Department, at one of 3 local community centers. The subjects will be evaluated at 0, 6 and 12 months with a 6 minute-walk-test. Secondary measures to be evaluated include the chronic respiratory disease questionnaire, an activity status index, sit-to-stand test and health-care utilization rates.
The investigator team is highly qualified and multi-disciplinary in nature. The two principal investigators have a complementary background, the first being physical therapist and the second a respiratory medicine specialist.

Assessment of the Proposal
This highly focused proposal addresses a novel and promising intervention that if proven successful could significantly impact on the quality of life of subjects with COPD and their disease-associated health-care costs.
The rationale for the study stems from the fact that individuals with COPD while hospitalized follow a proper physical therapy program, yet the compliance rate with home-exercise is poor. Such lack of at home exercise compliance results in limited exercise tolerance and negatively impacts on quality of life measures.
Other studies have shown evidence of a positive impact of a structured exercise program for post-hospital discharge COPD subjects. Yet, the available data refers to exercise program ran by medical personnel and thus financially costly. The applicants propose to develop a community based, fitness instructor-managed exercise program for individuals with COPD. 280 subjects will be recruited over a 24 month period and randomized to either a standard treatment that reflects present management of subjects with COPD, or the intervention treatment. The subjects in the experimental group will be required to attend at least twice a week, a community based qualified fitness instructor program to increase exercise tolerance to a number of well established and proven exercise routines. An assessor blinded to the group assessment will evaluate these subjects at timed intervals. The primary and secondary outcome measures are clearly defined, as well as inclusion and exclusion criteria. The applicants have elegantly designed the trial and ensured that the subject assessment bias will be minimized, or prevented altogether. The power analysis appears to ensure that an adequate sample size will be recruited to adequately evaluate the primary outcome measures.
Relatively minor concerns were raised by the reviewers during the previous submission. The applicants have, in the opinion of this reviewer, adequately addressed all these concerns. Preliminary data obtained by the investigators show sufficient evidence that the hypothesis is sound.
Interestingly and to great credit to the applicants, a detailed economic analysis of the impact of such exercise program on health care utilization rates, as well as quality of life of the subjects will be conducted. It is estimated that such exercise program, if indeed proven to be efficacious would result in a positive impact on both quality of life of COPD subjects and their health care costs.
The investigator team is highly qualified and their complementary expertise is indeed a great asset to this study. No significant weaknesses were identified with the present proposal.

Budget
The applicants request a full salary for research assistant, a technician and graduate student. The personnel needs are well justified and appropriate. The expendables and service items are equally justified and relatively small.