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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date March 2021
Source NHS Tayside
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Background: Pulmonary rehabilitation is an effective treatment after exacerbations of COPD to prevent future exacerbations and to improve breathlessness and quality of life. Its effectiveness after exacerbations of bronchiectasis has never been demonstrated. Aims: To determine if a 6 week course of pulmonary rehabilitation improves exercise capacity at 8 weeks after exacerbation. Study Design: Randomised controlled trial. Methods: The study will take place in NHS Tayside. 40 patients with a history of bronchiectasis confirmed by HRCT will be included. Patients will be monitored using diary cards for exacerbations. At the onset of an exacerbation patients will be treated with a standard 14 day course of antibiotic therapy and randomised to one of two arms: Pulmonary rehabilitation or standard care. Patients randomised to pulmonary rehabilitation will undergo a 6 week course of supervised pulmonary rehabilitation. Patients will undergo study assessments (6-minute walk test, Quality of life questionnaires, pulmonary function tests (FEV1, FVC, FEF 25-75), symptoms recorded by symptom diaries and sputum microbiology).Assessments will be performed at the start and end of exacerbations, at 6-8 weeks post exacerbation (after completion of pulmonary rehabilitation in patients randomised to rehabilitation) and at 12 weeks. Outcome: The primary outcome is 6 minute walk distance at 8 week post exacerbation Expected Conclusion: We will determine the effectiveness of pulmonary rehabilitation after exacerbations of bronchiectasis.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pulmonary rehabilitation
6 weeks of supervised exercise and education (pulmonary rehabilitation)
Pulmonary rehabilitation
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)

Locations

Country Name City State
United Kingdom Clinical Research Centre, University of Dundee Dundee

Sponsors (1)

Lead Sponsor Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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