Is Regular Chest Physiotherapy an Effective Treatment in Severe, 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
- 20
- 试验地点
- 1
- 主要终点
- 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
研究概览
简要总结
Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.
详细描述
Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of Edinburgh.
The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full instruction in use of the Acapella device (twice daily therapy) and ten patients will continue with their standard treatment regimen. The study will be conducted over seven months.
At the beginning we will randomly allocate them to receive either the current standard treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella physiotherapy device for the first 3 months.
After these 3 months all will receive the current standard treatment regimen for 1 month.
Following this, those that received current standard treatment will receive Acapella physiotherapy device for 3 months and those that received Acapella physiotherapy device will stop this and receive current standard treatment for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate and Severe Bronchiectasis
- •No regular chest physiotherapy
排除标准
- •Moderate or Severe COPD
研究组 & 干预措施
Acapella Physiotherapy
Physiotherapy with acapella versus no physiotherapy
干预措施: Acapella Physiotherapy (Device)
No physiotherapy
Physiotherapy with acapella versus no physiotherapy
结局指标
主要结局
24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire)
时间窗: 3 months
次要结局
- spirometry (FEV1, FVC, FEF 25-75), incremental shuttle test, St George's Respiratory Questionnaire and Nottingham Health Profile NHP-2, quantitative bacteriology.(3 months)