EFA: Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Sponsor

Lars Bo Andersen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01450423

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Epilepsia Epileptic Seizures Seizure Disorder	Behavioral: Physical activity	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

May 1, 2012

Anticipated Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity	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. Other Names: Cardio exercise program Cardio training program
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Physical activity

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.

Other Names:

Cardio exercise program

Cardio training program

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Physical handicaps which complicate participation in physical activity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Research in Childhood Health, University of Southern Denmark	Odense	Region of Southern Denmark	Denmark	5000
2	Epilepsy clinic, Odense University Hospital	Odense	Region of Southern Denmark	Denmark	5000