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

Completed

Conditions: Chronic obstructive pulmonary disease (COPD)
Respiratory
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN81447311

Lead Sponsor: Medisch Spectrum Twente (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

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)

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: duration and severity of the exacerbations. Measured by daily diaries which are filled out by all the patients during the total length of the study. <br>2. Effect of an exercise program within a self-management program: Functional exercise capacity: Shuttle Walk Test

Secondary Outcome Measures