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Completed

NCT Number: NCT00169897

Pulmonary Rehabilitation at Home Versus at the Gymnasium

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.

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Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St-Paul's Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary rehabilitation (teaching and exercise)

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 4 Intervention cost.

    Time frame: The data collection was terminated in January 2007.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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