Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Lars Bo Andersen
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Cognitive function (concentration and attention)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Physical activity
Intervention: Physical activity (Behavioral)
Control
Outcomes
Primary Outcomes
Cognitive function (concentration and attention)
Time Frame: 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
Time Frame: Before and after a 10-week intervention period
To assess physical fitness the following test are used: Wattmax test
Secondary Outcomes
- 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)
Investigators
Lars Bo Andersen
Professor
University of Southern Denmark