Condition category
Respiratory
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
17/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr François Maltais

ORCID ID

Contact details

Hôpital Laval
Centre de Pneumologie
2725
Chemin Ste-Foy
Sainte-Foy
Québec
G1V 4G5
Canada
+1 418 656 4747
francois.maltais@med.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00169897

Protocol/serial number

MCT-63162

Study information

Scientific title

Acronym

Study hypothesis

To compare the effectiveness of self-monitored, home-based rehabilitation versus outpatient hospital-based rehabilitation to improve quality of life in patients with chronic obstructive pulmonary disease (COPD).

Ethics approval

Comite d'ethique de la recherche, Hopital de Laval, QC, gave approval on the 24th November 2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Home-based exercise training for 12 weeks or hospital-based exercise training for 12 weeks.

Trial details received: 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Dyspnoea domain of the chronic respiratory questionnaire (CRQ) at 12 months

Secondary outcome measures

1. Total CRQ score and other CRQ domains, exercise tolerance (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 utilisation (physician and emergency department visits, hospitalisations) over the 1-year study period
4. Intervention cost

Overall trial start date

01/04/2003

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject is able to ambulate. Defined as a six-minute walking distance (6MWD) greater than 110 metres.
2. Subject is diagnosed with COPD
3. 40 years old and older, either sex
4. Currently or previously smoking with a smoking history of at least 10 pack-years
5. Forced expiratory volume in one second (FEV1) after the use of a bronchodilator between 25 and 70% of the predicted normal value, and FEV1 to forced vital capacity (FVC) ratio less than 70%
6. Subject has a stable COPD condition defined as no COPD exacerbation or no changes in dyspnoea, volume or colour of sputum in the previous 4 weeks
7. No previous diagnosis of:
7.1. Asthma
7.2. Left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction)
7.3. Terminal disease, dementia or uncontrolled psychiatric illness
8. No participation to a respiratory rehabilitation program in the past year and not staying or planning to stay in a long-term care facility
9. Subject understands and is able to read, write French or English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion

Recruitment start date

01/04/2003

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Hôpital Laval
Québec
G1V 4G5
Canada

Sponsor information

Organisation

University Laval (Canada)

Sponsor details

Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada

Sponsor type

University/education

Website

http://www.ulaval.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63162)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes