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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 10.1186/ISRCTN32824512
ClinicalTrials.gov identifier NCT00169897
EudraCT number
Public 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
Scientific title
Acronym N/A
Serial number at source MCT-63162
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).
Lay summary
Ethics approval Comite d'ethique de la recherche, Hopital de Laval, QC, gave approval on the 24th November 2003
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Chronic obstructive pulmonary disease (COPD)
Participants - 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
Participants - exclusion criteria The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion
Anticipated start date 01/04/2003
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 240
Interventions Home-based exercise training for 12 weeks or hospital-based exercise training for 12 weeks.

Trial details received: 12 Sept 2005
Primary outcome measure(s) Dyspnoea domain of the chronic respiratory questionnaire (CRQ) at 12 months
Secondary outcome measure(s) 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
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63162)
Trial website
Publications
Contact name Dr  François  Maltais
  Address Hôpital Laval
Centre de Pneumologie
2725, Chemin Ste-Foy
Sainte-Foy
  City/town Québec
  Zip/Postcode G1V 4G5
  Country Canada
  Tel +1 418 656 4747
  Fax +1 418 656 4762
  Email francois.maltais@med.ulaval.ca
Sponsor University Laval (Canada)
  Address Cité Universitaire, C.P. 2208
  City/town Québec
  Zip/Postcode G1K 7P4
  Country Canada
  Sponsor website: http://www.ulaval.ca/
Date applied 26/09/2005
Last edited 17/12/2008
Date ISRCTN assigned 26/09/2005
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