Epilepsia, Epilepsy, Epileptic Seizures, Seizure Disorder
Conditions
Keywords
Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function
Brief summary
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.
Interventions
BEHAVIORALPhysical activity
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.
Sponsors
Lars Bo Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age: 15-50 * Resident: Fyen, Denmark * Epileptic syndrome: Juvenile Myoclonic Epilepsy
Exclusion criteria
* Physical handicaps which complicate participation in physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function (concentration and attention) | 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 | Before and after a 10-week intervention period | To assess physical fitness the following test are used: Wattmax test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thyroidea Stimulating Hormone (TSH) | Before and after a 10-week intervention period | The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples. |
| Insulin | Before and after a 10-week intervention period | The level of insulin is assessed in fasting blood samples. |
| Glucose | Before and after a 10-week intervention period | The level of glucose is assessed in fasting blood samples |
| Brain-derived neurotrophic factor (BDNF) | Before and after a 10-week intervention period (chronic and acute) | 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. |
| C-reactive-protein | Before and after a 10-week intervention period | The level of c-reactive-protein is assessed in fasting blood samples. |
| Seizure frequency | Before and after a 10-week intervention period | Seizure frequency is assessed by a neurologist using a standard seizure calender. |
| Blood pressure | Before and after a 10-week intervention period | — |
| Lipids | Before and after a 10-week intervention period | The levels of lipids are assessed in fasting blood samples. |
| Bone mineral density | Before and after a 10-week intervention period | To assess bone mineral density the following test is used: DEXA-scanning |
Countries
Denmark
Outcome results
None listed