A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: Rationale and methods

Background: Pulmonary rehabilitation remains largely under-used. Self-monitored, home-based rehabilitation is a promising approach to improving the availability of pulmonary rehabilitation. Objective: To report the rationale and methods of a trial comparing the effectiveness of self-monitored, home-based rehabilitation with hospital-based, outpatient rehabilitation in patients with chronic obstructive pulmonary disease (COPD). Study design: A parallel-group, randomized, noninferiority, multicentre trial will be performed with 240 patients with moderate to severe COPD. Intervention: Patients will be randomly assigned to conventional, supervised, hospital-based outpatient rehabilitation or self-monitored, home-based rehabilitation. Both interventions will include a standardized, comprehensive self-management program, in addition to the hospital-based outpatient or home-based exercise program. After the three-month intervention, patients in both groups will be encouraged to continue exercising at home. Patients will be assessed monthly with telephone interviews and in person at enrollment, three months and 12 months. Outcomes: The dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) at 12 months is the primary outcome variable. Secondary outcome variables include total and domain-specific CRQ scores; exercise tolerance and activity of daily living; health service use over the one-year study period; and direct and indirect costs of COPD treatment. Analysis: An intent-to-treat approach will be used as the primary analysis. The primary analysis will focus on the change in the CRQ dyspnea score using a two-sided t distribution based on 95% CIs. The same approach will he used for secondary continuous outcome variables. Conclusion: The present trial will address two unresolved issues in pulmonary rehabilitation for patients with COPD: the short-term and long-term effectiveness of home-based pulmonary rehabilitation strategies. The authors will also determine if home-based pulmonary rehabilitation can reduce health service use (eg, hospitalizations and emergency visits) and if it can be done at a lower cost than the traditional hospital-based outpatient pulmonary rehabilitation.