Clinical trial NCT00169897: Pulmonary Rehabilitation at Home Versus at the Gymnasium
Official title: Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Exercise
Self-management
Rehabilitation
Quality of life
Health economy
Cost effectiveness
Health care utilization
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
First posted: 2005-09-15
Enrollment: 252
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
timeFrame: The data collection was terminated in January 2007 and publication was done December 2008
Secondary outcomes:
measure: 2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.
timeFrame: The data collection was terminated in January 2007.
measure: 3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.
timeFrame: The data collection was terminated in January 2007.
measure: 4 Intervention cost.
timeFrame: The data collection was terminated in January 2007.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St-Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Bonaventure
country: Canada
facility: CRMSBC/Centre Hospitalier Baie-des-Chaleurs
state: Quebec
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Levis
country: Canada
facility: Hopital Hotel-Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre-Coeur
state: Quebec
city: Montreal
country: Canada
facility: Mount Sinai Hospital
state: Quebec
city: Quebec City
country: Canada
facility: CHA Enfant Jesus
state: Quebec
city: Sainte-Foy
country: Canada
facility: Hopital Laval
state: Quebec
Study officials:
affiliation: Laval University - Hopital Laval
name: Francois Maltais, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
citation: Mak S, Bourbeau J, Mayo NE, Wood-Dauphinee S, Soicher JE. Psychometric Testing of the CHAMPS Questionnaire in French Canadians with COPD. Can Respir J. 2019 Sep 17;2019:2185207. doi: 10.1155/2019/2185207. eCollection 2019.