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ISRCTN
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ISRCTN32824512
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ClinicalTrials.gov identifier
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NCT00169897
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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MCT-63162
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Study hypothesis
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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).
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Ethics approval
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Comite d'ethique de la recherche, Hopital de Laval, QC, gave approval on the 24th November 2003
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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240
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Interventions
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Home-based exercise training for 12 weeks or hospital-based exercise training for 12 weeks.
Trial details received: 12 Sept 2005
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Primary outcome measure(s)
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Dyspnoea domain of the chronic respiratory questionnaire (CRQ) at 12 months
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63162)
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Trial website
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Publications
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Contact name
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Dr
François
Maltais
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Address
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Hôpital Laval
Centre de Pneumologie
2725, Chemin Ste-Foy
Sainte-Foy
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City/town
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Québec
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Zip/Postcode
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G1V 4G5
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Country
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Canada
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Tel
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+1 418 656 4747
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Fax
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+1 418 656 4762
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Email
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francois.maltais@med.ulaval.ca
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Sponsor
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University Laval (Canada)
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Address
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Cité Universitaire, C.P. 2208
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City/town
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Québec
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Zip/Postcode
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G1K 7P4
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Country
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Canada
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Sponsor website:
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http://www.ulaval.ca/
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Date applied
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26/09/2005
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Last edited
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17/12/2008
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Date ISRCTN assigned
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26/09/2005
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