Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- cardiorespiratory fitness (VO2peak)
研究概览
简要总结
To study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in children with Cystic Fibrosis (CF) (secondary outcomes).
详细描述
The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •boy/girl aged 6-17 years
- •living in the Madrid area
排除标准
- •severe lung deterioration [forced expiratory volume (FEV1) <50% of expected]
- •unstable clinical condition (hospitalization within the previous 3 months)
- •Burkholderia cepacia infection
- •any disorder (e.g. muscle-skeletal) impairing exercise.
结局指标
主要结局
cardiorespiratory fitness (VO2peak)
时间窗: this outcome will be assessed up to 12 weeks
maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis
次要结局
- quality of life(this outcome will be assessed up to 12 weeks)
研究者
Alejandro Lucia
MD PhD
Universidad Europea de Madrid