A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods.
BACKGROUND
Pulmonary rehabilitation remains largely underused. 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).


METHODS
A parallel-group, randomized, noninferiority, multicentre trial will be performed with 240 patients with moderate to severe COPD.


METHODS
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.


RESULTS
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.


METHODS
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 be used for secondary continuous outcome variables.


CONCLUSIONS
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.
Centre de rechereche, Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie de l'Université Laval, Sainte-Foy, Canada. francois.maltais@med.ulaval.ca
François
F
Maltais
Jean
J
Bourbeau
Yves
Y
Lacasse
Stan
S
Shapiro
Hélène
H
Perrault
John R
JR
Penrod
Marc
M
Baltzan
Michel
M
Rouleau
Marcel
M
Julien
Bruno
B
Paradis
Richard
R
Audet
Paul
P
Hernandez
Robert D
RD
Levy
Pat
P
Camp
Richard
R
Lecours
Danielle
D
Picard
Sarah
S
Bernard
D000328:Adult; D002170:Canada; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006699:Home Care Services / Q000458:organization & administration*; D006801:Humans; D008297:Male; D018579:Patient Selection; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology / Q000534:rehabilitation*; D012129:Respiratory Function Tests; D011795:Surveys and Questionnaires; D016896:Treatment Outcome