Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis: CF
- Age >18 years
- Amount of sputum >5 ml/60 min
- Wet inhalation of saline/DNase/both
- Informed consent
Exclusion Criteria:
- Respiratory failure
- Hemoptysis
- Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
- Ongoing intravenous medication
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Physiotherapy techniques
Cough Technique vs Forced Expiration Technique
|
Physiotherapy for Airway Clearance
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Expectorated sputum (gram)
大体时间: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. |
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient's experience, i.e. perceived utility value and preference of technique.
大体时间:8 weeks
|
Utility value: Measured by self-reported questionnaire after completion of each intervention in week 8. Preference: Measured by three self-reported questions after both interventions in week 8. |
8 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physiological measurements
大体时间:8 weeks
|
Oxygen saturation and heart rate measurements in the beginning and at the end of each intervention. Pulmonary function tests (week 2): measurements before and after each intervention with spirometry. |
8 weeks
|
|
Health related quality of life (HRQOL)
大体时间:8 weeks
|
HRQOL measured by the Cystic Fibrosis Questionnaire Revised (CFQR-R), i.e. respiratory symptoms, in the beginning and at completion of the study.
|
8 weeks
|
合作者和调查者
调查人员
- 首席研究员:Sandra Gursli, PT, MSc、Oslo University Hospital, National Centre for cystic fibrosis
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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