Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial
TRIBE
A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 8, 2021
March 1, 2021
4 years
June 29, 2014
March 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 minute walk distance
8 weeks post exacerbation
Secondary Outcomes (6)
Time to next exacerbation
6 months
The Quality of life
8 weeks and 12 weeks
Pulmonary function tests
8 weeks and 12 weeks
Respiratory symptoms
8 weeks and 12 weeks
Sputum microbiology
8 weeks and 12 weeks
- +1 more secondary outcomes
Study Arms (2)
Standard care
NO INTERVENTIONStandard care for exacerbation and follow-up without rehabilitation
Pulmonary rehabilitation
EXPERIMENTAL6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
Interventions
6 weeks of supervised exercise and education (pulmonary rehabilitation)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Taysidelead
Study Sites (1)
Clinical Research Centre, University of Dundee
Dundee, DD1 9SY, United Kingdom
Related Publications (1)
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.
PMID: 31060529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D Chalmers, MBChB, PhD
NHS Tayside
- PRINCIPAL INVESTIGATOR
Tom Fardon, MD
NHS Tayside
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2014
First Posted
July 2, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
March 8, 2021
Record last verified: 2021-03