Effects of a home-based versus hospital-based outpatient pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease (COPD): a multicentre, randomised trial
| ISRCTN | ISRCTN32824512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32824512 |
| ClinicalTrials.gov number | NCT00169897 |
| Secondary identifying numbers | MCT-63162 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr François Maltais
Scientific
Scientific
Hôpital Laval
Centre de Pneumologie
2725, Chemin Ste-Foy
Sainte-Foy
Québec
G1V 4G5
Canada
| Phone | +1 418 656 4747 |
|---|---|
| francois.maltais@med.ulaval.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Effects of a home-based versus hospital-based outpatient pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease (COPD): a multicentre, randomised trial |
| Study objectives | 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(s) | Comite d'ethique de la recherche, Hopital de Laval, QC, gave approval on the 24th November 2003 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2003 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Key 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 |
| Key exclusion criteria | The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hôpital Laval
Québec
G1V 4G5
Canada
G1V 4G5
Canada
Sponsor information
University Laval (Canada)
University/education
University/education
Cité Universitaire, C.P. 2208
Québec
G1K 7P4
Canada
| Website | http://www.ulaval.ca/ |
|---|---|
"ROR" |
https://ror.org/04sjchr03 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63162)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/12/2008 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added
