Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Phase 2

• Conditions: Epilepsy; Epilepsia; Epileptic Seizures; Seizure Disorder
• Interventions: Behavioral: Physical activity

• Registration Number: NCT01450423
• Lead Sponsor: Lars Bo Andersen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-09
• Study First Submitted QC: 2011-10-09
• Last Update Submitted: 2011-10-09
• Study First Posted: 2011-10-12
• Last Update Posted: 2011-10-12
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age: 15-50
• Resident: Fyen, Denmark
• Epileptic syndrome: Juvenile Myoclonic Epilepsy

Exclusion Criteria

• Physical handicaps which complicate participation in physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity	Physical activity	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Bone mineral density	Before and after a 10-week intervention period	To assess bone mineral density the following test is used: DEXA-scanning
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
Lipids	Before and after a 10-week intervention period	The levels of lipids are assessed in fasting blood samples.
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

Trial Locations

Locations (2)

Center of Research in Childhood Health, University of Southern Denmark; 🇩🇰 Odense, Region of Southern Denmark, Denmark

Epilepsy clinic, Odense University Hospital; 🇩🇰 Odense, Region of Southern Denmark, Denmark