Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
研究概览
简要总结
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.
详细描述
The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis.
Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month.
Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month.
During the study period the patients' pharmacological treatment remained unchanged
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic sputum production during at least 3 months previous enrolment
- •At least two confirmed exacerbations during the last year
- •Patients able to understand how to perform the airway clearance techniques
- •Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk)
- •To be able to provide written, informed consent
排除标准
- •Cystic Fibrosis
- •Carry out regular chest physiotherapy.
- •Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes)
- •Waiting a pulmonary transplant
结局指标
主要结局
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
时间窗: 1 year
Auto-administered questionnaire: Leicester Cough Questionnaire
次要结局
- Quality of life (Quality of life-Bronchiectasis questionnaire)(1 year)
- Lung function(1 year)
- Airway inflammation as assessed by spontaneous sputum analysis(1 year)
- Exercise capacity (Incremental field test: shuttle test)(1 year)
- Exacerbation frequency(1 year)