NCT01266473已完成不适用
Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
Oslo University Hospital0 个研究点目标入组 6 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Expectorated sputum (gram)
研究概览
简要总结
The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: CF
- •Age >18 years
- •Amount of sputum >5 ml/60 min
- •Wet inhalation of saline/DNase/both
- •Informed consent
排除标准
- •Respiratory failure
- •Hemoptysis
- •Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
- •Ongoing intravenous medication
- •Pregnancy
结局指标
主要结局
Expectorated sputum (gram)
时间窗: 8 weeks
Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g). N of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment.
次要结局
- Patient's experience, i.e. perceived utility value and preference of technique.(8 weeks)
研究者
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