Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis

Conditions
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Bronchiectasis

Intervention / Treatment
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* Procedure: Pulmonary rehabilitation
* Procedure: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Standard care for exacerbation and follow-up without rehabilitation | |
| Experimental: Pulmonary rehabilitation<br>6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation) | Procedure: Pulmonary rehabilitation<br>* 6 weeks of supervised exercise and education (pulmonary rehabilitation)<br>Procedure: Pulmonary rehabilitation<br>* 6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance |  | 8 weeks post exacerbation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to next exacerbation |  | 6 months | 
| The Quality of life | St Georges respiratory questionnaire COPD assessment test | 8 weeks and 12 weeks | 
| Pulmonary function tests | Pulmonary function tests (FEV1, FVC, FEF25-75) | 8 weeks and 12 weeks | 
| Respiratory symptoms | Patient diary cards | 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. | 8 weeks and 12 weeks | 
| 6 minute walk distance |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, rehabilitation, exercise, exacerbations