Tayside Rehabilitation in Bronchiectasis Exacerbations (TRIBE) : a Randomized Controlled Trial (TRIBE)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dundee, 영국, DD1 9SY
- Clinical Research Centre, University of Dundee
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참여기준
자격 기준
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연구 대상 성별
설명
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
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Standard care
Standard care for exacerbation and follow-up without rehabilitation
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실험적: Pulmonary rehabilitation
6 weeks of exercise and patient education after exacerbation (pulmonary rehabilitation)
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6 weeks of supervised exercise and education (pulmonary rehabilitation)
6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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6 minute walk distance
기간: 8 weeks post exacerbation
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8 weeks post exacerbation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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다음 악화까지의 시간
기간: 6 개월
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6 개월
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The Quality of life
기간: 8 weeks and 12 weeks
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St Georges respiratory questionnaire COPD assessment test
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8 weeks and 12 weeks
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Pulmonary function tests
기간: 8 weeks and 12 weeks
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Pulmonary function tests (FEV1, FVC, FEF25-75)
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8 weeks and 12 weeks
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Respiratory symptoms
기간: 8 weeks and 12 weeks
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Patient diary cards
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8 weeks and 12 weeks
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Sputum microbiology
기간: 8 weeks and 12 weeks
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Proportion of patients with positive sputum microbiology of potential pathogenic microorganisms (Haemophilus influenzae, Pseudomonas aeruginosa, Moraxella catarrhalis, enterobacteriaceae) versus patients without sputum colonisation.
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8 weeks and 12 weeks
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6 minute walk distance
기간: 12 weeks
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12 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: James D Chalmers, MBChB, PhD, NHS Tayside
- 수석 연구원: Tom Fardon, MD, NHS Tayside
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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Pulmonary rehabilitation에 대한 임상 시험
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