Pulmonary Rehabilitation at Home Versus at the Gymnasium

NCT ID: NCT00169897

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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COPD

Keywords

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COPD Exercise Self-management Rehabilitation Quality of life Health economy Cost effectiveness Health care utilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Hospital-based

This group has to go at the hospital 3 times per week to do the exercise program.

Group Type EXPERIMENTAL

Pulmonary rehabilitation (teaching and exercise)

Intervention Type BEHAVIORAL

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.

Home-Based

The group had to do the exercise program at home with indirect supervision (Polar watches and a phone call per week).

Group Type ACTIVE_COMPARATOR

Pulmonary rehabilitation (teaching and exercise)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Laval University

Principal Investigators

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Francois Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University - Hopital Laval

Locations

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St-Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Halifax Infirmary

Halifax, Nova Scotia, Canada

Site Status

CRMSBC/Centre Hospitalier Baie-des-Chaleurs

Bonaventure, Quebec, Canada

Site Status

Jewish Rehabilitation Hospital

Laval, Quebec, Canada

Site Status

Hopital Hotel-Dieu de Levis

Lévis, Quebec, Canada

Site Status

Montreal Chest Institute

Montreal, Quebec, Canada

Site Status

Hopital Sacre-Coeur

Montreal, Quebec, Canada

Site Status

Mount Sinai Hospital

Montreal, Quebec, Canada

Site Status

CHA Enfant Jesus

Québec, Quebec, Canada

Site Status

Hopital Laval

Sainte-Foy, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33511633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31636770 (View on PubMed)

Other Identifiers

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ISRCTN32824512

Identifier Type: -

Identifier Source: org_study_id