A Randomized Controlled Trial of Pulmonary Rehabilitation After Exacerbations of Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- NHS Tayside
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 6 minute walk distance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
6 minute walk distance
时间窗: 8 weeks post exacerbation
次要结局
- The Quality of life(8 weeks and 12 weeks)
- Sputum microbiology(8 weeks and 12 weeks)
- Time to next exacerbation(6 months)
- Pulmonary function tests(8 weeks and 12 weeks)
- Respiratory symptoms(8 weeks and 12 weeks)
- 6 minute walk distance(12 weeks)