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
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