COPE II-study.
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
1. FEV1 between 25% and 80% of the predicted value;
2. Three or more exacerbations or one hospitalization 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. Age between 40 and 75 years;
6. A clinical diagnosis of COPD as defined by the GOLD-criteria (9);
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.
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 hospitalization 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Effect of self-treatment within a self-management program: <br>Duration and severity of the exacerbations <br>Measured by daily diaries which are filled out by all the patients during the total length of the study; <br><br>2. Effect of an exercise program within a self-management program:<br>Functional exercise capacity:<br>Shuttle Walk Test.
- Secondary Outcome Measures
Name Time Method