Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes in myotonia
研究概览
简要总结
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.
详细描述
Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.
The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with either Myotonia congenita or Paramyotonia congenita.
- •Patients who have symptoms of myotonia while they are walking stairs.
排除标准
- •Pregnant or breastfeeding women.
- •Physical or mental condition, which prevent participating in the study protocol or which could influence the results.
- •Participating in other studies, which could influence the results.
结局指标
主要结局
Changes in myotonia
时间窗: Week 0 and week 10
Changes in myotonia is assessed before and after 10 weeks of exercise training. Myotonia is measured as self-assessment of myotonia using the Myotonia Behavior Scale every day in a week before training start and every day in a week before training finish. Furthermore, myotonia is measured as changes in time climbing a 14 steps stair before and after the 10 weeks training period.
次要结局
- Changes in fitness(baseline and after week 10)
- Changes in creatine Kinase(baseline, week 2, week 4, week 7 and week 10)
- Changes in other myotonia(baseline and after week 10)
研究者
Grete Andersen, MD
Medical Doctor
Rigshospitalet, Denmark