- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450423
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Region of Southern Denmark
-
Odense, Region of Southern Denmark, Denmark, 5000
- Recruiting
- Center of Research in Childhood Health, University of Southern Denmark
-
Contact:
- Lars Bo Andersen, Professor
- Phone Number: +4565504380
- Email: lboandersen@health.sdu.dk
-
Contact:
- Karsten Froberg, Ass. prof.
- Phone Number: +4565503457
- Email: kfroberg@health.sdu.dk
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Sub-Investigator:
- Karsten Froberg, ass.prof.
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Sub-Investigator:
- Anne K Thorsen, Stud.scient
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Principal Investigator:
- Lars Bo Andersen, Professor
-
Odense, Region of Southern Denmark, Denmark, 5000
- Recruiting
- Epilepsy clinic, Odense University Hospital
-
Contact:
- Ioannis Tsiropoulos, consult.ph.d
- Phone Number: +45 65412438
- Email: ioannis.tsiropoulos@ouh.regionsyddanmark.dk
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Principal Investigator:
- Ioannis Tsiropoulos, consult.ph.d
-
Sub-Investigator:
- Anne K Thorsen, Stud.scient.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 15-50
- Resident: Fyen, Denmark
- Epileptic syndrome: Juvenile Myoclonic Epilepsy
Exclusion Criteria:
- Physical handicaps which complicate participation in physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Before and after a 10-week intervention period
|
physical fitness
Time Frame: Before and after a 10-week intervention period
|
To assess physical fitness the following test are used: Wattmax test
|
Before and after a 10-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain-derived neurotrophic factor (BDNF)
Time Frame: 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.
|
Before and after a 10-week intervention period (chronic and acute)
|
Bone mineral density
Time Frame: Before and after a 10-week intervention period
|
To assess bone mineral density the following test is used: DEXA-scanning
|
Before and after a 10-week intervention period
|
Thyroidea Stimulating Hormone (TSH)
Time Frame: Before and after a 10-week intervention period
|
The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples.
|
Before and after a 10-week intervention period
|
Insulin
Time Frame: Before and after a 10-week intervention period
|
The level of insulin is assessed in fasting blood samples.
|
Before and after a 10-week intervention period
|
Glucose
Time Frame: Before and after a 10-week intervention period
|
The level of glucose is assessed in fasting blood samples
|
Before and after a 10-week intervention period
|
Lipids
Time Frame: Before and after a 10-week intervention period
|
The levels of lipids are assessed in fasting blood samples.
|
Before and after a 10-week intervention period
|
C-reactive-protein
Time Frame: Before and after a 10-week intervention period
|
The level of c-reactive-protein is assessed in fasting blood samples.
|
Before and after a 10-week intervention period
|
Seizure frequency
Time Frame: Before and after a 10-week intervention period
|
Seizure frequency is assessed by a neurologist using a standard seizure calender.
|
Before and after a 10-week intervention period
|
Blood pressure
Time Frame: Before and after a 10-week intervention period
|
Before and after a 10-week intervention period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Bo Andersen, Professor, Center of Research in Childhood Health (RICH), University of Southern Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20110080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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