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临床试验/NCT02700282
NCT02700282已完成4 期

Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis

Groupe Hospitalier du Havre2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
27
试验地点
2
主要终点
Lung Function (Forced Vital Capacity)

研究概览

简要总结

Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a progressive decline in lung function.

School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle strength is also impaired.

No studies assessed aerobic capacities during children's gait while carrying a backpack.

The investigators hypothesized that backpack carrying will induce an acute decline in lung function in children with cystic fibrosis compared to healthy children. Investigators also hypothesized that aerobic capacities will be impaired.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cystic Fibrosis
  • School-aged children (10 to 18)

排除标准

  • Backpack carrying contraindication
  • Acute exacerbation
  • Impossible gait
  • Other respiratory disease (asthma ...)

结局指标

主要结局

Lung Function (Forced Vital Capacity)

时间窗: Immediate assessment while standing

次要结局

  • Lung function (Forced Expiratory Volume in 1 second)(Immediate assessment while standing)
  • Respiratory Muscle Strength (MIP)(Immediate assessment while standing)
  • Respiratory Muscle Strength (MEP)(Immediate assessment while standing)
  • Oxygen uptake (VO2)(During 12min treadmill gait)
  • Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)(During 12min treadmill gait)
  • Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)(During 12min treadmill gait)
  • Dyspnea (Borg Scale)(During 12min treadmill gait)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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