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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Dundee、イギリス、DD1 9SY
- Clinical Research Centre, University of Dundee
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Standard care
Standard care for exacerbation and follow-up without rehabilitation
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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6 minute walk distance
時間枠：8 weeks post exacerbation
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8 weeks post exacerbation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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次の増悪までの時間
時間枠：6ヵ月
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6ヵ月
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The Quality of life
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 weeks
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12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：James D Chalmers, MBChB, PhD、NHS Tayside
- 主任研究者：Tom Fardon, MD、NHS Tayside
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Pulmonary rehabilitationの臨床試験
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