Pulmonary Rehabilitation at Home Versus at the Gymnasium - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 12, 2006

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pulmonary Rehabilitation at Home Versus at the Gymnasium

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Active Control, Parallel Assignment

Condition ^ICMJE

Chronic Obsctructive Pulmonary Disease

Intervention ^ICMJE

Behavioral: Pulmonary rehabilitation (teaching and exercise)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

252

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00169897

Responsible Party

Study ID Numbers ^ICMJE

ISRCTN32824512

Study Sponsor ^ICMJE

Laval University

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec

Investigators ^ICMJE

Principal Investigator:

Francois Maltais, MD

Laval University - Hopital Laval

Information Provided By

Laval University

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP