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

NCT ID: NCT02179983

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

Standard care for exacerbation and follow-up without rehabilitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pulmonary rehabilitation

6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: PROCEDURE

6 weeks of supervised exercise and education (pulmonary rehabilitation)

Pulmonary rehabilitation

Intervention Type: PROCEDURE

6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)

Interventions

Pulmonary rehabilitation

6 weeks of supervised exercise and education (pulmonary rehabilitation)

Intervention Type: PROCEDURE

Pulmonary rehabilitation

6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Tayside

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D Chalmers, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Tom Fardon, MD

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Locations

Clinical Research Centre, University of Dundee

Dundee, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31060529 (View on PubMed)

Other Identifiers

NHSTayside

Identifier Type: -

Identifier Source: org_study_id