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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179983
Recruitment Status : Active, not recruiting
First Posted : July 2, 2014
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
NHS Tayside

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.


Condition or disease Intervention/treatment Phase
Bronchiectasis Procedure: Pulmonary rehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
Actual Study Start Date : June 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Standard care
Standard care for exacerbation and follow-up without rehabilitation
Experimental: Pulmonary rehabilitation
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
Procedure: Pulmonary rehabilitation
6 weeks of supervised exercise and education (pulmonary rehabilitation)

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




Primary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: 8 weeks post exacerbation ]

Secondary Outcome Measures :
  1. Time to next exacerbation [ Time Frame: 6 months ]
  2. The Quality of life [ Time Frame: 8 weeks and 12 weeks ]
    St Georges respiratory questionnaire COPD assessment test

  3. Pulmonary function tests [ Time Frame: 8 weeks and 12 weeks ]
    Pulmonary function tests (FEV1, FVC, FEF25-75)

  4. Respiratory symptoms [ Time Frame: 8 weeks and 12 weeks ]
    Patient diary cards

  5. Sputum microbiology [ Time Frame: 8 weeks and 12 weeks ]
    Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation.

  6. 6 minute walk distance [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179983


Locations
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United Kingdom
Clinical Research Centre, University of Dundee
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
Investigators
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Principal Investigator: James D Chalmers, MBChB, PhD NHS Tayside
Principal Investigator: Tom Fardon, MD NHS Tayside

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Tayside
ClinicalTrials.gov Identifier: NCT02179983     History of Changes
Other Study ID Numbers: NHSTayside
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Keywords provided by NHS Tayside:
Bronchiectasis
rehabilitation
exercise
exacerbations
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases