Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial (TRIBE)
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|ClinicalTrials.gov Identifier: NCT02179983|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2014
Last Update Posted : April 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Procedure: Pulmonary rehabilitation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis|
|Actual Study Start Date :||June 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
No Intervention: Standard care
Standard care for exacerbation and follow-up without rehabilitation
Experimental: Pulmonary rehabilitation
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
Procedure: Pulmonary rehabilitation
6 weeks of supervised exercise and education (pulmonary rehabilitation)
Procedure: 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 [ Time Frame: 8 weeks and 12 weeks ]St Georges respiratory questionnaire COPD assessment test
- Pulmonary function tests [ Time Frame: 8 weeks and 12 weeks ]Pulmonary function tests (FEV1, FVC, FEF25-75)
- Respiratory symptoms [ Time Frame: 8 weeks and 12 weeks ]Patient diary cards
- Sputum microbiology [ Time Frame: 8 weeks and 12 weeks ]Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation.
- 6 minute walk distance [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179983
|Clinical Research Centre, University of Dundee|
|Dundee, United Kingdom, DD1 9SY|
|Principal Investigator:||James D Chalmers, MBChB, PhD||NHS Tayside|
|Principal Investigator:||Tom Fardon, MD||NHS Tayside|