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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Bo Andersen, Professor | Center of Research in Childhood Health (RICH), University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Research in Childhood Health, University of Southern Denmark | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
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| Label | URL |
|---|---|
| Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark | View source |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 |
| Epilepsy clinic, Odense University Hospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |