Back to resultsRehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary rehabilitation
conventional care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Effect of Pulmonary rehabilitation., Exercise capacity, Quality of life
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of moderate COPD.
- Motivation for Pulmonary rehabilitation.
Exclusion Criteria:
- Comorbidity contraindicating rehabilitation.
- Participation in pulmonary rehabilitation within the last year.
- Cognitive disorders limiting the ability to participate in physical training and education sessions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pulmonary rehabilitation
Control
Arm Description
A standardized 7 week rehabilitation program, including physical training and education.
Conventional care
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01320930
First Posted
March 22, 2011
Last Updated
March 22, 2011
Sponsor
Bispebjerg Hospital
Collaborators
Ministry of the Interior and Health, Denmark, Danish Lung Association, Sygekassernes Helsefond
1. Study Identification
Unique Protocol Identification Number
NCT01320930
Brief Title
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Early Detection and Rehabilitation of Subjects With COPD - Rehabilitation in Moderate COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Ministry of the Interior and Health, Denmark, Danish Lung Association, Sygekassernes Helsefond
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Effect of Pulmonary rehabilitation., Exercise capacity, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary rehabilitation
Arm Type
Active Comparator
Arm Description
A standardized 7 week rehabilitation program, including physical training and education.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Conventional care
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
conventional care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of moderate COPD.
Motivation for Pulmonary rehabilitation.
Exclusion Criteria:
Comorbidity contraindicating rehabilitation.
Participation in pulmonary rehabilitation within the last year.
Cognitive disorders limiting the ability to participate in physical training and education sessions.
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)
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