NCT04153669已完成不适用
Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)
Universidad Europea de Madrid2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Strength
研究概览
简要总结
This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF
- •Age: 6-18 years old
- •Signature of informed consent of legal guardian and patient.
排除标准
- •Being a smoker
- •Having had an exacerbation in the last 3 months
- •Having undergone gastric surgery
- •Having enteral nutrition at present
- •The patients will come from the HIUNJ of Madrid.
- •Currently taking CFTR modulators
结局指标
主要结局
Change in Strength
时间窗: Two assessment points throughout the study: baseline and 8 weeks after the intervention
Changes in strength will be measured using a five repetition maximum test (5RM)
次要结局
- Change in Cardiorespiratory Fitness(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
- Changes in Pulmonary Function(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
- Change in quality of life(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
- Changes in physical activity levels(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
- Food consumption frequency(One assessment point at baseline:baseline and 8 weeks after the intervention)
研究者
Margarita Perez
Full Professor in Exercise Physiology, MD, PhD
Universidad Europea de Madrid
研究点 (2)
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