Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial

Conditions
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Epilepsy, Epilepsia, Epileptic Seizures, Seizure Disorder

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 15-50 Resident: Fyen, Denmark Epileptic syndrome: Juvenile Myoclonic Epilepsy Exclusion Criteria: Physical handicaps which complicate participation in physical activity

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br> | Behavioral: Physical activity<br>* Participation in a 10-week supervised cardio exercise program two-three times a week. Each training session consists of 10 minutes of warm-up, 20 minutes treadmill run/walk and 30 minutes cycling. Heart rate (HR) is monitored during each session. Week 1-5: at least 15 minutes above 75% of HRmax in each session. Week 6-10: at least one session above 75% HRmax.<br>* Other names: Cardio training program;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function (concentration and attention) | 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 | Before and after a 10-week intervention period | 
| physical fitness | To assess physical fitness the following test are used: Wattmax test | Before and after a 10-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived neurotrophic factor (BDNF) | The chronic level of serum brain-derived neurotrophic factor (BDNF) is assessed in fasting blood samples. The acute level of serum BDNF is assessed in blood samples drawn immediately after completed wattmax test. | Before and after a 10-week intervention period (chronic and acute) | 
| Bone mineral density | To assess bone mineral density the following test is used: DEXA-scanning | Before and after a 10-week intervention period | 
| Thyroidea Stimulating Hormone (TSH) | The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples. | Before and after a 10-week intervention period | 
| Insulin | The level of insulin is assessed in fasting blood samples. | Before and after a 10-week intervention period | 
| Glucose | The level of glucose is assessed in fasting blood samples | Before and after a 10-week intervention period | 
| Lipids | The levels of lipids are assessed in fasting blood samples. | Before and after a 10-week intervention period | 
| C-reactive-protein | The level of c-reactive-protein is assessed in fasting blood samples. | Before and after a 10-week intervention period | 
| Seizure frequency | Seizure frequency is assessed by a neurologist using a standard seizure calender. | Before and after a 10-week intervention period | 
| Blood pressure |  | Before and after a 10-week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function