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| Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial [with consumer summary] |
| Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S, Chronic Obstructive Pulmonary Disease Axis of Respiratory Health Network Fonds de Recherche en Sante du Quebec |
| Annals of Internal Medicine 2008 Dec 16;149(12):869-878 |
| clinical trial |
| 8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Home-based rehabilitation is a promising approach to improve access to pulmonary rehabilitation. OBJECTIVE: To assess whether self-monitored, home-based rehabilitation is as effective as outpatient, hospital-based rehabilitation in patients with chronic obstructive pulmonary disease (COPD). DESIGN: Randomized, multicenter, noninferiority trial. SETTING: 10 academic and community medical centers in Canada. PATIENTS: 252 patients with moderate to severe COPD. INTERVENTION: After a 4-week education program, patients took part in home-based rehabilitation or outpatient, hospital-based rehabilitation for 8 weeks. They were followed for 40 weeks to complete the 1-year study. MEASUREMENTS: The primary outcome was the change in Chronic Respiratory Questionnaire dyspnea subscale score at 1 year. The primary analysis took a modified intention-to-treat approach by using all patients who provided data at the specified follow-up time, regardless of their level of adherence. The analysis used regression modeling that adjusted for the effects of center, sex, and baseline level. All differences were computed as home intervention minus outpatient intervention. RESULTS: Both interventions produced similar improvements in the Chronic Respiratory Questionnaire dyspnea subscale at 1 year: improvement in dyspnea of 0.62 (95% CI 0.43 to 0.80) units in the home intervention (n = 107) and 0.46 (CI 0.28 to 0.64) units in the outpatient intervention (n = 109). The difference between the 2 treatments at 1 year was small and clinically unimportant. The 95% CI of the difference did not exceed the prespecified noninferiority margin of 0.5: difference in dyspnea score of 0.16 (CI -0.08 to 0.40). Most adverse events were related to COPD exacerbations. No serious adverse event was considered to be related to the study intervention. LIMITATION: The contribution of the educational program to the improvement in health status and exercise tolerance cannot be ascertained. CONCLUSION: Home rehabilitation is a useful, equivalent alternative to outpatient rehabilitation in patients with COPD.
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