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

Bronchiectasis Clinical Trial

— TRIBE  

Official title:

A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02179983
• Other study ID #: NHSTayside
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bronchiectasis

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