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

Primary Purpose

Bronchiectasis

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Pulmonary rehabilitation
Sponsored by
NHS Tayside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, rehabilitation, exercise, exacerbations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Centre, University of Dundee

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Pulmonary rehabilitation

Arm Description

Standard care for exacerbation and follow-up without rehabilitation

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

Outcomes

Primary Outcome Measures

6 minute walk distance

Secondary Outcome Measures

Time to next exacerbation
The Quality of life
St Georges respiratory questionnaire COPD assessment test
Pulmonary function tests
Pulmonary function tests (FEV1, FVC, FEF25-75)
Respiratory symptoms
Patient diary cards
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.
6 minute walk distance

Full Information

First Posted
June 29, 2014
Last Updated
March 5, 2021
Sponsor
NHS Tayside
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1. Study Identification

Unique Protocol Identification Number
NCT02179983
Brief Title
Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial
Acronym
TRIBE
Official Title
A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Tayside

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, rehabilitation, exercise, exacerbations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care for exacerbation and follow-up without rehabilitation
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
6 weeks of supervised exercise and education (pulmonary rehabilitation)
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
Primary Outcome Measure Information:
Title
6 minute walk distance
Time Frame
8 weeks post exacerbation
Secondary Outcome Measure Information:
Title
Time to next exacerbation
Time Frame
6 months
Title
The Quality of life
Description
St Georges respiratory questionnaire COPD assessment test
Time Frame
8 weeks and 12 weeks
Title
Pulmonary function tests
Description
Pulmonary function tests (FEV1, FVC, FEF25-75)
Time Frame
8 weeks and 12 weeks
Title
Respiratory symptoms
Description
Patient diary cards
Time Frame
8 weeks and 12 weeks
Title
Sputum microbiology
Description
Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation.
Time Frame
8 weeks and 12 weeks
Title
6 minute walk distance
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Chalmers, MBChB, PhD
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Fardon, MD
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre, University of Dundee
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31060529
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.
Results Reference
derived

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

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