Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 40
Exclusion Criteria
- Age <18 years
- Cystic Fibrosis
- Inability to give informed consent to participate
- ...
- Age <18 years
- Cystic Fibrosis
- Inability to give informed consent to participate
- Primary diagnosis of Chronic Obstructive Pulmonary Disease
- Recent myocardial infarction (within previous year)or unstable angina
- Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease.
- Aortic aneurysm
Summary
- Conditions
- Bronchiectasis
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Exclusion Criteria
- Age <18 years
- Cystic Fibrosis
- Inability to give informed consent to participate
- ...
- Age <18 years
- Cystic Fibrosis
- Inability to give informed consent to participate
- Primary diagnosis of Chronic Obstructive Pulmonary Disease
- Recent myocardial infarction (within previous year)or unstable angina
- Significant comorbidity that would limit the ability to undertake pulmonary rehabilitation - i.e. Cerebrovascular, cardiovascular or musculoskeletal disease.
- Aortic aneurysm
Tracking Information
- NCT #
- NCT02179983
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James D Chalmers, MBChB, PhD NHS Tayside Principal Investigator: Tom Fardon, MD NHS Tayside
- James D Chalmers, MBChB, PhD NHS Tayside Principal Investigator: Tom Fardon, MD NHS Tayside
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