Pulmonary Rehabilitation at Home Versus at the Gymnasium

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: January 12, 2006 History of Changes

Sponsor:	Laval University
Collaborators:	Canadian Institutes of Health Research (CIHR) Fonds de la Recherche en Santé du Québec
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00169897

Purpose

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.

Condition	Intervention
Chronic Obsctructive Pulmonary Disease	Behavioral: Pulmonary rehabilitation (teaching and exercise)

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Effects of a Home-Based Versus a Hospital-Based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.

Secondary Outcome Measures:

1-Total CRQ score and other CRQ domains, exercise tolerance (6 min walking distance (6MWD) and submaximal exercise test) and activity of daily living(ADL) at 12 months.
2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.
3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.
4 Intervention cost.

Estimated Enrollment:	252
Study Start Date:	January 2004
Estimated Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	40 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 illeness.
Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long terme 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169897

Locations

Canada, British Columbia
St-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Quebec
Hopital Laval
Sainte-Foy, Quebec, Canada, G1V 4G5
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Mount Sinai Hospital
Montreal, Quebec, Canada, H4W 1S7
Hopital Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Jewish Rehabilitation Hospital
Laval, Quebec, Canada, H7V 1R2
Hopital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
CRMSBC/Centre Hospitalier Baie-des-Chaleurs
Bonaventure, Quebec, Canada, G0C 1YO
CHA Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4

Sponsors and Collaborators

Laval University

Canadian Institutes of Health Research (CIHR)

Fonds de la Recherche en Santé du Québec

Investigators

Principal Investigator:

Francois Maltais, MD

Laval University - Hopital Laval

More Information

No publications provided

Study ID Numbers:	ISRCTN32824512
Study First Received:	September 13, 2005
Last Updated:	January 12, 2006
ClinicalTrials.gov Identifier:	NCT00169897 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

COPD
Exercise
Self-management
Rehabilitation

Quality of life
Health economy
Cost effectiveness
Health care utilization

Additional relevant MeSH terms:

Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on February 08, 2010