Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Cognitive function (concentration and attention)
研究概览
简要总结
Epilepsy is a chronic neurologic disorder characterized by seizures. Beside seizures people suffering from epilepsy experience several challenges related to education, work and everyday life such as learning-, problem-solving-, memory-, concentration-, attention difficulties and fatigue.
It is generally approved that physical activity (PA) has a positive effect on physical as well as mental factors. However, people with epilepsy are found to be less active and PA is rarely offered or recommended as supplement to anti-epileptic medical treatment. Few studies have investigated the effect of PA in subjects with epilepsy and additional studies of high methodical quality are needed to enable evidence-based information and counselling.
This study is carried through as a randomized controlled trial which investigates the effect of participation in a 10-week cardio exercise program in people with Juvenile Myoclonic Epilepsy aged 15-50.
The study hypothesis is that participation in a 10-week cardio exercise program will induce a positive change in cognitive function (concentration and attention) and possibly in brain-derived neurotrophic factor (BDNF). In addition it is expected that the intensity and duration of the 10-week cardio exercise program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 15-50
- •Resident: Fyen, Denmark
- •Epileptic syndrome: Juvenile Myoclonic Epilepsy
排除标准
- •Physical handicaps which complicate participation in physical activity
结局指标
主要结局
Cognitive function (concentration and attention)
时间窗: Before and after a 10-week intervention period
To assess cognitive function the following tests are used: Connor's Continuous Performance Test (CPT II), Trail Making Test part A and part B, Digit Symbol Modalities Test
physical fitness
时间窗: Before and after a 10-week intervention period
To assess physical fitness the following test are used: Wattmax test
次要结局
- Brain-derived neurotrophic factor (BDNF)(Before and after a 10-week intervention period (chronic and acute))
- Bone mineral density(Before and after a 10-week intervention period)
- Thyroidea Stimulating Hormone (TSH)(Before and after a 10-week intervention period)
- Insulin(Before and after a 10-week intervention period)
- Glucose(Before and after a 10-week intervention period)
- Lipids(Before and after a 10-week intervention period)
- C-reactive-protein(Before and after a 10-week intervention period)
- Seizure frequency(Before and after a 10-week intervention period)
- Blood pressure(Before and after a 10-week intervention period)
研究者
Lars Bo Andersen
Professor
University of Southern Denmark