Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- change body fat mass index
研究概览
简要总结
Aim of the randomized controlled trial is to investigate the effects of endurance training with different intensities on physical performance, body composition and appetite regulation in people with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of cystic fibrosis by at least 2 sweat tests and / or by the presence of two CF mutations,
- •willingness to participate in and to comply with the research project procedure,
- •written informed consent of patients,
- •age ≥ 18 years,
- •FEV1 of pred. ≥ 40%,
- •Stable condition (as indicated by absence of one or more signs: new or increased haemoptysis, increased malaise, fatigue or lethargy, temperature over 38°C, weight loss, sinus pain and a decrease in pulmonary function by 10% or more)
排除标准
- •Severe pulmonary exacerbation,
- •cor pulmonale,
- •musculoskeletal discomfort that makes a regular exercise training impossible,
- •untreated CF-related diabetes
结局指标
主要结局
change body fat mass index
时间窗: at baseline and after 4 weeks of exercise training program
measured with body fat mass index (FMI) in kg / m\*2
change in Body fat free mass index
时间窗: at baseline and after 4 weeks of exercise training program
measured with fat free body mass index (FFMI) in kg / m\*2
change in Peak Oxygen Uptake
时间窗: at baseline and after 4 weeks of exercise training program
measured with peak Oxygen uptake (VO2) in percent predicted
change in Peak Workload
时间窗: at baseline and after 4 weeks of exercise training program
measured with peak Workload in percent predicted
次要结局
- change in Forced Expiratory Volume in 1 second(at baseline and after 4 weeks of exercise training program)
- appetite control - subjective feeling of hunger(at baseline and after 4 weeks of exercise training program)
- change in Health related quality of life(at baseline and six and twelve months after completion of exercise training program)
研究者
Prof. Dr. Dr. Anja Bosy-Westphal
Prof. Dr. Dr. Anja Bosy-Westphal
University of Kiel