Pulmonary Rehabilitation at Home Versus at the Gymnasium

Study Overview
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Brief Summary
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Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation.

Detailed Description
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This article on the main outcome is available. 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. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.

Official Title
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Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Pulmonary rehabilitation (teaching and exercise)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to ambulate. Defined as a 6MWD greater than 110 meters. Subject is diagnosed with COPD. 40 years-old and older Currently or previously smoking with a smoking history of at least 10 pack-years. Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70%. No previous diagnosis of asthma, left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction), terminal disease, dementia or uncontrolled psychiatric illness. Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long term care facility. Subject understands and is able to read and write French or English. MRC dyspnea scale of at least 2. Exclusion Criteria: The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospital-based<br>This group has to go at the hospital 3 times per week to do the exercise program. | Behavioral: Pulmonary rehabilitation (teaching and exercise)<br>* After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.<br>|
| Active Comparator: Home-Based<br>The group had to do the exercise program at home with indirect supervision (Polar watches and a phone call per week). | Behavioral: Pulmonary rehabilitation (teaching and exercise)<br>* After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. | 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. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878. | The data collection was terminated in January 2007 and publication was done December 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months. |  | The data collection was terminated in January 2007. | 
| 3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period. |  | The data collection was terminated in January 2007. | 
| 4 Intervention cost. |  | The data collection was terminated in January 2007. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exercise, Self-management, Rehabilitation, Quality of life, Health economy, Cost effectiveness, Health care utilization