Status:
UNKNOWN
Maintenance Schedules Following Pulmonary Rehabilitation
Lead Sponsor:
University of East Anglia
Conditions:
Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Eligibility:
All Genders
35-65 years
Phase:
PHASE2
Brief Summary
Chronic obstructive pulmonary disease (COPD), a preventable and treatable condition, is a major healthcare problem with huge human and economic costs. It affects 3 million people, results in 1.4 milli...
Detailed Description
This will be a randomised, controlled, parallel study of a maintenance pulmonary rehabilitation (PR) programme in patients with chronic obstructive pulmonary disease (COPD). Following successful compl...
Eligibility Criteria
Inclusion
- Male or female, aged more than 35 years
- Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
- Ex or current smoker of more than 20 pack years
- FEV1 less than 80% of predicted
- Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines.
- Patients having attended at least 60% of the exercise sessions in the initial PR(22)\* \* This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study
Exclusion
- Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms.
- Myocardial infarction within the previous 6 months or unstable angina
- Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation.
- Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study.
- Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study.
- Unable to give written informed consent.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00925171
Start Date
June 1 2009
End Date
June 1 2012
Last Update
August 4 2011
Active Locations (2)
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1
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
2
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ