Bronchiectasis Clinical Trial
— TRIBEOfficial title:
A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
NCT number | NCT02179983 |
Other study ID # | NHSTayside |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | June 2018 |
Verified date | March 2021 |
Source | NHS Tayside |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pulmonary rehabilitation is well established as a treatment in COPD. After exacerbations of COPD, rehabilitation is associated with reduced frequency of exacerbations and improved exercise capacity. No data are available in bronchiectasis. This study will randomly assign patients with bronchiectasis exacerbations to pulmonary rehabilitation or standard care. The hypothesis is that exercise capacity will be improved by pulmonary rehabilitation at 8 weeks.
Status | Terminated |
Enrollment | 48 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Bronchiectasis confirmed on High Resolution CT scan Clinical Bronchiectasis confirmed by a respiratory physician. Documented exacerbation within the last year. Independently mobile - i.e. able to undertake pulmonary rehabilitation Exclusion Criteria: - Inability to give informed consent to participate - Age <18 years - Primary diagnosis of Chronic Obstructive Pulmonary Disease - Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease. - Cystic Fibrosis - Aortic aneurysm - Recent myocardial infarction (within previous year)or unstable angina |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research Centre, University of Dundee | Dundee |
Lead Sponsor | Collaborator |
---|---|
NHS Tayside |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 minute walk distance | 8 weeks post exacerbation | ||
Secondary | Time to next exacerbation | 6 months | ||
Secondary | The Quality of life | St Georges respiratory questionnaire COPD assessment test | 8 weeks and 12 weeks | |
Secondary | Pulmonary function tests | Pulmonary function tests (FEV1, FVC, FEF25-75) | 8 weeks and 12 weeks | |
Secondary | Respiratory symptoms | Patient diary cards | 8 weeks and 12 weeks | |
Secondary | Sputum microbiology | Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation. | 8 weeks and 12 weeks | |
Secondary | 6 minute walk distance | 12 weeks |
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