Clinical trial NCT02179983: Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial
Official title: A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
rehabilitation
exercise
exacerbations
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2014-07-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 minute walk distance
timeFrame: 8 weeks post exacerbation
Secondary outcomes:
measure: Time to next exacerbation
timeFrame: 6 months
measure: The Quality of life
timeFrame: 8 weeks and 12 weeks
measure: Pulmonary function tests
timeFrame: 8 weeks and 12 weeks
measure: Respiratory symptoms
timeFrame: 8 weeks and 12 weeks
measure: Sputum microbiology
timeFrame: 8 weeks and 12 weeks
measure: 6 minute walk distance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Clinical Research Centre, University of Dundee
Study officials:
affiliation: NHS Tayside
name: James D Chalmers, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Tayside
name: Tom Fardon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chalmers JD, Crichton ML, Brady G, Finch S, Lonergan M, Fardon TC. Pulmonary rehabilitation after exacerbation of bronchiectasis: a pilot randomized controlled trial. BMC Pulm Med. 2019 May 6;19(1):85. doi: 10.1186/s12890-019-0856-0.