Pulmonary Rehabilitation at Home Versus at the Gymnasium

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169897
• Other study ID #: ISRCTN32824512
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 11, 2010
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: August 2005
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Pulmonary rehabilitation (teaching and exercise)
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.

Locations

Country	Name	City	State
Canada	CRMSBC/Centre Hospitalier Baie-des-Chaleurs	Bonaventure	Quebec
Canada	Halifax Infirmary	Halifax	Nova Scotia
Canada	Jewish Rehabilitation Hospital	Laval	Quebec
Canada	Hopital Hotel-Dieu de Levis	Levis	Quebec
Canada	Hopital Sacre-Coeur	Montreal	Quebec
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	Mount Sinai Hospital	Montreal	Quebec
Canada	CHA Enfant Jesus	Quebec City	Quebec
Canada	Hopital Laval	Sainte-Foy	Quebec
Canada	St-Paul's Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.		The data collection was terminated in January 2007.	Yes
Secondary	4 Intervention cost.		The data collection was terminated in January 2007.	No