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Clinical Trials/ISRCTN81447311
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.

Registry
who.int
Start Date
December 20, 2005
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medisch Spectrum Twente (Netherlands)

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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