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

September 13, 2005
November 11, 2010
January 2004
January 2007   (final data collection date for primary outcome measure)
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.
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
Complete list of historical versions of study NCT00169897 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Pulmonary Rehabilitation at Home Versus at the Gymnasium
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
COPD
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.
  • Experimental: Hospital-based
    This group has to go at the hospital 3 times per week to do the exercise program.
    Intervention: Behavioral: Pulmonary rehabilitation (teaching and exercise)
  • 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).
    Intervention: Behavioral: Pulmonary rehabilitation (teaching and exercise)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
January 2007
January 2007   (final data collection date for primary outcome measure)

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.
Both
40 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00169897
ISRCTN32824512
No
Francois Maltais, Laval University
Laval University
  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
Principal Investigator: Francois Maltais, MD Laval University - Hopital Laval
Laval University
August 2005

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