Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in plasmatic levels of Klotho
研究概览
简要总结
Cystic fibrosis (CF) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. Inflammation is a key component contributing to the main alterations induced by the disease. The increase in life expectancy comes with a higher prevalence of CF-related comorbidities, but also with new emerging complications directly related to aging. Physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. Thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.
详细描述
This study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients 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
- Single (Outcomes Assessor)
盲法说明
Evaluators of outcomes will be masked as for the study group of each participant.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical and genetic diagnosis for cystic fibrosis;
- •Age from 16 years.
排除标准
- •Musculoskeletal disorders that do not allow the performance of physical exercise;
- •Pregnancy;
- •Absence of registration of clinical required.
结局指标
主要结局
Change in plasmatic levels of Klotho
时间窗: Baseline and 8 weeks
Change from baseline to 8 weeks
Change in peripheral muscle strength. Upper and lower limb muscle strength will be evaluated using the 5 maximum repetition test in specific strength machines. Handgrip strength will be measured with a dynamometer.
时间窗: Baseline and 8 weeks
Change from baseline to 8 weeks
Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)
时间窗: Baseline and 8 weeks
Change from baseline to 8 weeks
Change in plasmatic levels of interleukins (IL-8 and IL-10)
时间窗: Baseline and 8 weeks
Change from baseline to 8 weeks
次要结局
- Change in Pulmonary Function (Lung Function)(Baseline and 8 weeks)
- Change in quality of life evaluated using the Cystic Fibrosis Questionnaire (CFQ-R +14). Scores range from 0 to 100 with higher scores corresponding to better quality of life.(Baseline and 8 weeks)
- Change in inspiratory muscle strength (MIP)(Baseline and 8 weeks)
- Change in functional capacity (30 seconds sit-to-stand test)(Baseline and 8 weeks)
研究者
Margarita Perez
Professor in Exercise Physiology
Universidad Europea de Madrid