Pulmonary Rehabilitation at Home Versus at the Gymnasium

November 11, 2010 updated by: Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hospital-based
This group has to go at the hospital 3 times per week to do the exercise program.
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.
ACTIVE_COMPARATOR: Home-Based
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)
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.

What is the study measuring?

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.
Time Frame: The data collection was terminated in January 2007 and publication was done December 2008
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
Time Frame
2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.
Time Frame: The data collection was terminated in January 2007.
The data collection was terminated in January 2007.
3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.
Time Frame: The data collection was terminated in January 2007.
The data collection was terminated in January 2007.
4 Intervention cost.
Time Frame: The data collection was terminated in January 2007.
The data collection was terminated in January 2007.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

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

Investigators

  • Principal Investigator: Francois Maltais, MD, Laval University - Hopital Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 11, 2010

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISRCTN32824512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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