Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.
研究概览
简要总结
The aim of our study is to ascertain whether chest physiotherapy + pulmonary rehabilitation is more efficacious than chest physiotherapy alone. The outcomes that will be used to assess effectiveness are relevant in terms of the direct benefit on the patient's health related quality of life.
PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.
详细描述
PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.
PLAN OF INVESTIGATION: Patients will be recruited from NHS Lothian with 15 randomized to chest physiotherapy and 15 to chest physiotherapy plus pulmonary rehabilitation.
Protocols:
Chest physiotherapy Physiotherapy will be aided using a positive pressure airways device (Acapella) that aids sputum expectoration. They will be asked to do 10 breaths, followed by 3 huffs and a cough. This will be repeated 3 times and repeated twice a day. Expected tiime 10-15 minutes twice daily.
Pulmonary rehabiliation Will be an 8-week programme twice a week in hospital with a third session (unsupervised) at home. It will include both cardiovascular training and upper limb and lower limb strengthening exercises.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate and severe bronchiectasis aged 18-75 will be recruited. Severity will be assessed radiologically by HRCT of the chest using the scoring method by Bhalla et al.
排除标准
- •cystic fibrosis
- •emphysema on HRCT chest and FEV1<60% predicted
- •active allergic bronchopulmonary aspergillosis or tuberculosis
- •poorly controlled asthma
- •pregnancy or breast feeding
- •current smokers
结局指标
主要结局
The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.
时间窗: 8 weeks
次要结局
- These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.(8 weeks)
研究者
Adam Hill
Consultant Physician and Honorary Senior Lecturer
NHS Lothian