跳至主要内容
临床试验/NCT01509235
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

Hospices Civils de Lyon0 个研究点目标入组 34 人开始时间: 2006年3月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

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