Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Epilepsy Clinical Trial

— EFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01450423
• Other study ID #: S-20110080
• Status: Recruiting
• Phase: Phase 2
• First received: October 9, 2011
• Last updated: October 9, 2011
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2011
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Epilepsia
• Epilepsies, Myoclonic
• Epilepsy
• Epileptic Seizures
• Seizure Disorder
• Seizures

Intervention

Behavioral:
• Physical 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.

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Lars Bo Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	physical fitness	To assess physical fitness the following test are used: Wattmax test	Before and after a 10-week intervention period	No
Secondary	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)	No
Secondary	Bone mineral density	To assess bone mineral density the following test is used: DEXA-scanning	Before and after a 10-week intervention period	No
Secondary	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	No
Secondary	Insulin	The level of insulin is assessed in fasting blood samples.	Before and after a 10-week intervention period	No
Secondary	Glucose	The level of glucose is assessed in fasting blood samples	Before and after a 10-week intervention period	No
Secondary	Lipids	The levels of lipids are assessed in fasting blood samples.	Before and after a 10-week intervention period	No
Secondary	C-reactive-protein	The level of c-reactive-protein is assessed in fasting blood samples.	Before and after a 10-week intervention period	No
Secondary	Seizure frequency	Seizure frequency is assessed by a neurologist using a standard seizure calender.	Before and after a 10-week intervention period	No
Secondary	Blood pressure		Before and after a 10-week intervention period	No

External Links

•   Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark