An interventional study of Pulmonary rehabilitation and Pulmonary rehabilitation in Bronchiectasis, sponsored by NHS Tayside. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-08.
Sponsored by NHS Tayside · Not applicable, Interventional, and Treatment
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.
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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →NHS Tayside is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Standard care for exacerbation and follow-up without rehabilitation
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
Procedure: Pulmonary rehabilitation
6 weeks of supervised exercise and education (pulmonary rehabilitation)
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
6 minute walk distance
Time frame: 8 weeks post exacerbation
Time to next exacerbation
Time frame: 6 months
The Quality of life
St Georges respiratory questionnaire COPD assessment test
Time frame: 8 weeks and 12 weeks
Pulmonary function tests
Pulmonary function tests (FEV1, FVC, FEF25-75)
Time frame: 8 weeks and 12 weeks
Respiratory symptoms
Patient diary cards
Time frame: 8 weeks and 12 weeks
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.
Time frame: 8 weeks and 12 weeks
6 minute walk distance
Time frame: 12 weeks
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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NHS Tayside