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Pulmonary Rehabilitation at Home Versus at the Gymnasium

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00169897
First received: September 13, 2005
Last updated: November 11, 2010
Last verified: August 2005
  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
COPD
Behavioral: Pulmonary rehabilitation (teaching and exercise)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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:


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. [ Time Frame: The data collection was terminated in January 2007 and publication was done December 2008 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 4 Intervention cost. [ Time Frame: The data collection was terminated in January 2007. ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: January 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
CRMSBC/Centre Hospitalier Baie-des-Chaleurs
Bonaventure, Quebec, Canada, G0C 1YO
Jewish Rehabilitation Hospital
Laval, Quebec, Canada, H7V 1R2
Hopital Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Hopital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Mount Sinai Hospital
Montreal, Quebec, Canada, H4W 1S7
CHA Enfant Jesus
Quebec City, Quebec, Canada, G1J 1Z4
Hopital Laval
Sainte-Foy, Quebec, Canada, G1V 4G5
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

Responsible Party: Francois Maltais, Laval University
ClinicalTrials.gov Identifier: NCT00169897     History of Changes
Other Study ID Numbers: ISRCTN32824512
Study First Received: September 13, 2005
Last Updated: November 11, 2010
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

ClinicalTrials.gov processed this record on November 25, 2014