ISRCTN81447311
Completed
Not Applicable
Study of the effects of self-treatment and an exercise program within a self-management program in outpatients with chronic obstructive pulmonary disease (COPD): the COPE II-study
Medisch Spectrum Twente (Netherlands)0 sites200 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease (COPD)
- Sponsor
- Medisch Spectrum Twente (Netherlands)
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Forced expiratory volume in one second (FEV1\) between 25% and 80% of the predicted value
- •2\. Three or more exacerbations or one hospitalisation in the two years preceding study entry
- •3\. A signed and dated written informed consent from the subject prior to study participation
- •4\. Patients of the outpatient clinic of the Medisch Spectrum Twente
- •5\. Aged between 40 and 75 years
- •6\. A clinical diagnosis of COPD as defined by the GOLD\-criteria
- •7\. Stable and well controlled COPD, at least one month before inclusion
- •8\. Current smoker or ex\-smoker
- •9\. Able to understand, read and write Dutch
Exclusion Criteria
- •1\. Serious other disease with a low survival rate
- •2\. Other disease which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoïdosis)
- •3\. Severe psychiatric illness
- •4\. A disregulation of diabetes mellitus during an exacerbation in the past or a hospitalisation for diabetes mellitus in the two years preceding the study
- •5\. Need for regular oxygen therapy
- •6\. Maintenance therapy with antibiotics
- •7\. Known alpha1 antitrypsine deficiency
- •8\. Disorders or progressive diseases, which influence seriously the ability to walk (e.g. amputation, paralysis, progressive muscle diseases)
Outcomes
Primary Outcomes
Not specified
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