High Intensity Interval Training in Patients With Facioscapulohumeral Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incremental test
研究概览
简要总结
The investigators aim to investigate the effect of high-intensity training in patients with facioscapulohumeral muscular dystrophy. Can patients benefit from this type of exercise without muscle damage.
详细描述
Clinical trials have in recent years demonstrated that aerobic exercise, are both effective and safe in patients with facioscapulohumeral muscular dystrophy. Previous studies have tested exercise at moderate intensity. No studies have so far investigated whether high-intensity-training (HIIT) exercise can increase fitness, or the training will cause muscle damage. However, we know that patients with facioscapulohumeral muscular dystrophy do not get increased muscle damage after a single exercise at high intensity.
Investigators aim to investigate whether patients with facioscapulohumeral muscular disease may increase their fitness and improve their functioning in everyday life without muscle injury in a time-saving high intensity training.
To investigate whether HIIT is safe and effective, three groups of participants are included. Two training groups, one group of patients and another with healthy matched subjects. The training is done on an ergometer-bike three times a week for 8 weeks. One weekly training will be supervised. The training consists of an interval training program (10-20-30). The third group is a none-training control group of patients. This group will undergo the same tests as the two training groups.
To investigate wether participants would continue HIIT training after 8 weeks of supervised training, the two training groups, one group of patients and one group of healthy matched subjects, are tested after additional 8 weeks of home based optional training.
To investigate wether patients with muscular dystrophy facioscapulohumeral will perform unsupervised HIIT training and whether it will be as effective as the supervised training, the control group of patients who did not train the first 8 weeks, is instructed to do home based HIIT for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Diagnosed with Facioscapulohumeral muscular dystrophy or
- •healthy matched control, matched for age, gender, BMI and activity level.
排除标准
- •More than 1 hour cardiac exercise weekly before inclusion.
- •Pregnant or breastfeeding women.
- •Physical or mental condition, which could influence the results.
- •Participating in other studies, which could influence the results.
- •Physical or mental condition, which prevent participating in the study protocol.
结局指标
主要结局
Incremental test
时间窗: week 1,6,11 and 18
An incremental test is performed at baseline (week 1), after 4 weeks interval training, in the end of 8 weeks interval training, and after another 8 week of individual home based training. The primary outcome is change from baseline in maximal oxygen consumption and work load.
次要结局
- Self-assessment(Every day in week 1-11)
- Creatine Kinase(week 1,6,11 and 18)
- Activity level(baseline, week 10 and week 18.)
- Physical function(baseline, week 6,11 and 18)
研究者
Grete Andersen, MD
MD
Rigshospitalet, Denmark