NCT00169897

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 15, 2010

Status Verified

August 1, 2005

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

November 11, 2010

Conditions

COPD

Keywords

COPDExerciseSelf-managementRehabilitationQuality of lifeHealth economyCost effectivenessHealth care utilization

Outcome Measures

Primary Outcomes (1)

  • The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.

    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 Outcomes (3)

  • 2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.

    The data collection was terminated in January 2007.

  • 3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.

    The data collection was terminated in January 2007.

  • 4 Intervention cost.

    The data collection was terminated in January 2007.

Study Arms (2)

Hospital-based

EXPERIMENTAL

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

Behavioral: Pulmonary rehabilitation (teaching and exercise)

Home-Based

ACTIVE COMPARATOR

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)

Interventions

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.

Home-BasedHospital-based

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is able to ambulate. Defined as a 6MWD greater than 110 meters.
  • Subject is diagnosed with COPD.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

St-Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

CRMSBC/Centre Hospitalier Baie-des-Chaleurs

Bonaventure, Quebec, G0C 1YO, Canada

Location

Jewish Rehabilitation Hospital

Laval, Quebec, H7V 1R2, Canada

Location

Hopital Hotel-Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Hopital Sacre-Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

Mount Sinai Hospital

Montreal, Quebec, H4W 1S7, Canada

Location

CHA Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Hopital Laval

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 33511633DERIVED

  • 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.

    PMID: 31636770DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityPatient Acceptance of Health Care

Interventions

Educational StatusExercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Francois Maltais, MD

    Laval University - Hopital Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 15, 2010

Record last verified: 2005-08

Locations

CA(10)