Pulmonary Rehabilitation at Home Versus at the Gymnasium
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | November 11, 2010 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. [ Time Frame: The data collection was terminated in January 2007 and publication was done December 2008 ] [ Designated as safety issue: No ] Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878. |
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| Original Primary Outcome Measures ICMJE |
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. | ||||
| Change History | Complete list of historical versions of study NCT00169897 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pulmonary Rehabilitation at Home Versus at the Gymnasium | ||||
| Official Title ICMJE | Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial | ||||
| Brief Summary | Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation. |
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| Detailed Description | This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | COPD | ||||
| Intervention ICMJE | Behavioral: Pulmonary rehabilitation (teaching and exercise)
After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 252 | ||||
| Completion Date | January 2007 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00169897 | ||||
| Other Study ID Numbers ICMJE | ISRCTN32824512 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Francois Maltais, Laval University | ||||
| Study Sponsor ICMJE | Laval University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Laval University | ||||
| Verification Date | August 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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