Effects of Home-Based Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease

A Randomized Trial

16 December 2008 | Volume 149 Issue 12 | Pages 869-878

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.

Editors' Notes Context Pulmonary rehabilitation programs improve outcomes, but access to outpatient, hospital-based programs is very limited. Contribution In a 10-center, randomized, noninferiority trial in Canada, investigators randomly assigned 252 patients to home-based or outpatient, hospital-based exercise training for 8 weeks. At 1 year, the 2 interventions had reduced dyspnea by the same amount, as measured on the dyspnea subscale of the Chronic Respiratory Questionnaire. The difference between the programs in dyspnea at 1 year was statistically very unlikely to be clinically important. Caution The study was unblinded, and its primary outcome was self-reported. Implication Home-based pulmonary rehabilitation is a reasonable alternative to hospital-based programs. —The Editors

 

Author and Article Information

From Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie de l'Université Laval and Centre Hospitalier Universitaire Associé, Québec City, Québec; Montreal Chest Institute, McGill University Health Centre, McGill University, Mount Sinai Hospital, and Hôpital Sacré-Coeur, Montréal, Québec; Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia; Jewish Rehabilitation Hospital, Laval, Québec; St. Paul's Hospital, Vancouver, British Columbia; Hôtel-Dieu de Lévis, Lévis, Québec; Centre Hospitalier Baie-des-Chaleurs, Maria, Québec; and Ottawa Health Research Institute Clinical Epidemiology Program, The Ottawa Hospital, Ottawa, Ontario, Canada.

Note: Drs. Maltais and Bourbeau contributed equally to this study.

Acknowledgment: Completion of this study was possible because of the dedication of the study personnel of each participating centre: Hôpital Laval (Denise Légaré, Marthe Bélanger, Marie-Josée Breton, Brigitte Jean, Hélène Villeneuve, Micheline Paquin, Josée Picard, Catherine Gignac, Mathieu Couture, and Emmanuelle Bernard); Montreal Chest Institute (Palmina Mancino, Judith Soicher, Alexandre Joubert, Isabelle Drouin, Ann Hatzoglou, and Hanèn M'Kaouar); Queen Elizabeth II Health Sciences Centre (Tracy Seaman, Erin McAndrew, Andrea Dale, Christina MacDonald, Colm McParland, and Joyce McCormack); Centre Hospitalier Universitaire Associé de Québec (Ghyslaine Dubé and Louise Pagé) Mount Sinai Hospital (Jennie-Laure Sully, Benoît Major, Mira Mierzwinski, Maria Stathatos, Michelle Houde, and Julie Bouchard); Hôpital Sacré-Coeur (Line Pineau, Claire St-Arnaud, Suzanne Valois, and Andrée Gagnon); Jewish Rehabilitation Hospital (Annie Berthiaume, Lucie Boutin, Louise Cossette, Maria Boggia, and Loredana Campo); Hôtel-Dieu de Lévis (Joan Morin and Jacynthe Bédard); St. Paul's Hospital (Jane Burns, Rhonda Johnston, and Fiona Topp); Centre Hospitalier Baie-des-Chaleurs (Nancy Loiselle, Denise Cyr, Réal Robichaud, Valérie Delarosbile, Amélie Allard, and Caroline Leblanc). The authors also thank Dr. Éric Rousseau, Mr. Yvan Fortier, and Dany Janvier from the Laboratoire de Télématique Biomédicale du Réseau en Santé Respiratoire du Fonds de la recherche en santé du Québec. The authors acknowledge the contribution of Dr. Richard Debigaré and Dr. Pierre LeBlanc, who first developed the home exercise-training program that served as the basis for the home intervention used in the study.

Grant Support: By a Canadian Institutes of Health Research grant (MCT-63162) and by the Respiratory Health Network of the Fonds de la recherche en santé du Québec. Dr. Maltais is a research scholar of the Fonds de la recherche en santé du Québec. Dr. Bourbeau is recipient of a John R. and Clara Fraser Memorial Award from the Faculty of Medicine, McGill University.

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement: Study protocol: Available from Dr. Maltais (e-mail, francois.maltais{at}med.ulaval.ca). Statistical code: Not available. Data set: Available from Dr. Maltais (e-mail, francois.maltais{at}med.ulaval.ca) after obtaining the agreement of the steering committee.

Requests for Single Reprints: François Maltais, MD, Centre de Pneumologie, Hôpital Laval, 2725 Chemin Ste-Foy, Québec, Québec G1V 4G5, Canada (e-mail, francois.maltais{at}med.ulaval.ca); or Jean Bourbeau, MD, MSc, Institut thoracique de Montréal, 3650 St-Urbain, Montréal, Québec H2X 2P4, Canada (e-mail, jean.bourbeau{at}mcgill.ca).

Current Author Addresses: Drs. Maltais and Lacasse: Hôpital Laval, Centre de pneumologie, 2725 Chemin Ste-Foy, Québec, Québec G1V 4G5, Canada.

Dr. Bourbeau: Institut thoracique de Montréal, Département de pneumologie, 3650 St-Urbain, Montréal, Québec H2X 2P4, Canada.

Dr. Shapiro: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Purvis Hall, 1020 Pine Avenue West, Montreal, Québec H3A 1A2, Canada.

Dr. Perrault: McGill University, James Administration Building, Room 600, McGill University, 845 Sherbrooke Street West, Montréal, Québec H3A 2T5, Canada.

Dr. Baltzan: Centre hospitalier Mont-Sinaï, Département de pneumologie, 5690 boulevard Cavendish, Montréal, Québec H4W 1S7, Canada.

Dr. Hernandez: Dalhousie University, Room 4458, Halifax Infirmary, 1796 Summer Street, Halifax, Nova Scotia B3H 3A7, Canada, Québec.

Dr. Rouleau: Hôpital St-Sacrement, 1050 Chemin Ste-Foy, Québec, Québec G1S 4L8, Canada.

Drs. Julien and Parenteau: Hôpital Sacré-Cœur-de-Montréal, 5e étage, 5400 boulevard Gouin ouest, Montréal, Québec H4J 1C5, Canada.

Dr. Paradis: Cité de la Santé de Laval, 1755 boulevard de la Santé, Laval, Québec H7M 3L9, Canada.

Dr. Levy: St. Paul's Hospital, Respiratory Division, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.

Dr. Camp: St. Paul's Hospital, Physiotherapy Department, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.

Dr. Lecours: Hôtel-Dieu de Lévis, 143 rue Wolfe, Lévis, Québec G6V 3Z1, Canada.

Dr. Audet: Centre hospitalier Baie-des-Chaleurs, 419 boulevard Perron, Maria, Québec G0C 1Y0, Canada.

Mr. Hutton: The Ottawa Hospital, 501 Smyth Road, Box 201, Ottawa, Ontario K1H 8L6, Canada.

Dr. Penrod: Bristol-Myers Squibb, 777 Scudders Mill Road, Plainsboro, NJ 08540.

Ms. Picard: Centre de recherche de la Direction régionale de la Santé Publique, 2400 avenue d'Estimauville, Québec, Québec G1E 7G9, Canada.

Ms. Bernard: Hôpital Laval, PPMC, bureau P-0961, 2725 Chemin Ste-Foy, Québec, Québec G1V 4G5, Canada.

Author Contributions: Conception and design: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, J.R. Penrod, D. Picard, S. Bernard.

Analysis and interpretation of the data: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, B. Hutton, J.R. Penrod, S. Bernard.

Drafting of the article: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, S. Bernard.

Critical revision of the article for important intellectual content: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, P. Hernandez, M. Rouleau, M. Julien, S. Parenteau, B. Paradis, R.D. Levy, P. Camp, R. Lecours, R. Audet, B. Hutton, J.R. Penrod, D. Picard, S. Bernard.

Final approval of the article: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, P. Hernandez, M. Rouleau, M. Julien, S. Parenteau, B. Paradis, R.D. Levy, P. Camp, R. Lecours, R. Audet, B. Hutton, J.R. Penrod, D. Picard, S. Bernard.

Provision of study materials or patients: F. Maltais, J. Bourbeau, M. Baltzan, P. Hernandez, M. Rouleau, M. Julien, S. Parenteau, B. Paradis, R.D. Levy, P. Camp, R. Lecours, R. Audet, D. Picard, S. Bernard.

Statistical expertise: S. Shapiro, B. Hutton.

Obtaining of funding: F. Maltais, J. Bourbeau.

Administrative, technical, or logistic support: F. Maltais, J. Bourbeau, S. Shapiro, Y. Lacasse, H. Perrault, M. Baltzan, D. Picard, S. Bernard.

Collection and assembly of data: F. Maltais, J. Bourbeau, M. Baltzan, P. Hernandez, M. Rouleau, M. Julien, S. Parenteau, B. Paradis, R.D. Levy, P. Camp, R. Lecours, R. Audet, D. Picard, S. Bernard.

ClinicalTrials.gov registration number: NCT00169897.

ISRCTN registration number: ISRCTN32824512.