NCT01509235已完成不适用
Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- weight of sputum that was expectorated
研究概览
简要总结
In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
- •Age : 7 to 17 years
- •Capacity to expectorate
- •Clinically stable
- •Ability to pedal on a bike and to respect orders for physical session
排除标准
- •Haemoptysis > 50ml
- •Permanent non-invasive ventilation
- •Respiration or digestive evolutive clinical abnormality
- •Exacerbation
结局指标
主要结局
weight of sputum that was expectorated
时间窗: 12 months
The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.
次要结局
- patient's satisfaction(12 months)
研究者
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