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临床试验/NCT01854788
NCT01854788已完成不适用

A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Weight of sputum expectorated during each airway clearance therapy session

研究概览

简要总结

Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.

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

  • •Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
  • •Mean sputum production ≥ 15 ml /24h
  • •Clinical stability in the last 6 weeks
  • •Not carrying out regular chest physiotherapy
  • •Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow >270 L/s

排除标准

  • •Smoker or non-smoker form less than 2 years
  • •Cystic fibrosis
  • •Active tuberculosis or sarcoidosis

研究组 & 干预措施

Autogenic drainage

Active Comparator

All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

干预措施: Autogenic drainage (Other)

Slow expiration with glottis opened in lateral posture

Active Comparator

All patients performed all interventions in a randomized order.Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

干预措施: Slow expiration with glottis opened in lateral posture (Other)

Temporary-Positive Expiratory Pressure

Active Comparator

All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes

干预措施: Temporary-positive expiratory pressure (Other)

结局指标

主要结局

Weight of sputum expectorated during each airway clearance therapy session

时间窗: 40 minutes

Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

Weight of sputum expectorated 24 hours post each bronchial session

时间窗: 24 hours

Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

次要结局

  • Saint George Respiratory Questionnaire (SGRQ)(Change from baseline at 5 weeks)
  • Leicester Cough Questionnaire (LCQ)(Changes from baseline arm to 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatriz Herrero

Physiotherapist

Hospital Clinic of Barcelona

研究点 (1)

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