BronchiectasisTRIBENCT02179983
Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial
A study testing Pulmonary rehabilitation in people with Bronchiectasis, run by NHS Tayside at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Centre, University of Dundee
Dundee, DD1 9SY
About this study
Official title: A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
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.
Read the 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
- Being tested
- Pulmonary rehabilitation
- Keywords
- Bronchiectasis, rehabilitation, exercise, exacerbations
- Medical subject headings
- Bronchiectasis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
6 weeks of supervised exercise and education (pulmonary rehabilitation)
Pulmonary rehabilitationProcedure or surgery
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Standard care for exacerbation and follow-up without rehabilitation |
| Pulmonary rehabilitation | Experimental | 6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation) Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk distance
Measured: 8 weeks post exacerbation
Secondary outcomes (6)
Time to next exacerbation
Measured: 6 months
The Quality of life
St Georges respiratory questionnaire COPD assessment test
Measured: 8 weeks and 12 weeks
Pulmonary function tests
Pulmonary function tests (FEV1, FVC, FEF25-75)
Measured: 8 weeks and 12 weeks
Respiratory symptoms
Patient diary cards
Measured: 8 weeks and 12 weeks
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.
Measured: 8 weeks and 12 weeks
6 minute walk distance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- James D Chalmers, MBChB, PhD, Principal investigator, NHS TaysideTom Fardon, MD, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179983
- Sponsor's protocol ID
- NHSTayside
- Acronym
- TRIBE
- Status last verified
- Mar 2021
- First submitted
- 29 Jun 2014
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31060529
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
- ClinicalTrials.gov ID
- NCT02179983
- Acronym / sponsor ID
- TRIBE / NHSTayside
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, rehabilitation, exercise, exacerbations
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Standard care for exacerbation and follow-up without rehabilitation |
| Pulmonary rehabilitation | Experimental | Procedure: Pulmonary rehabilitation6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation6 weeks of supervised exercise and education (pulmonary rehabilitation) | Procedure or surgery | Pulmonary rehabilitation |
| Pulmonary rehabilitation6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation) | Procedure or surgery | Pulmonary rehabilitation |
Primary outcome
6 minute walk distance
Time frame: 8 weeks post exacerbation
6 secondary outcomes
Time to next exacerbation
Time frame: 6 months
The Quality of life
Time frame: 8 weeks and 12 weeks
Pulmonary function tests
Time frame: 8 weeks and 12 weeks
Respiratory symptoms
Time frame: 8 weeks and 12 weeks
Sputum microbiology
Time frame: 8 weeks and 12 weeks
6 minute walk distance
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 31060529Chalmers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Chalmers, MBChB, PhD principal investigator
NHS Tayside
Tom Fardon, MD principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Bronchiectasis, run by NHS Tayside at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk distance (time frame: 8 weeks post exacerbation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.