Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)
This study is currently recruiting participants.
Verified October 2011 by University of Southern Denmark
Sponsor:
Lars Bo Andersen
Information provided by (Responsible Party):
Lars Bo Andersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01450423
First received: October 9, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Epilepsy Epilepsia Epileptic Seizures Seizure Disorder |
Behavioral: Physical activity |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
juvenile myoclonic epilepsy
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by University of Southern Denmark:
Primary Outcome Measures:
- Cognitive function (concentration and attention) [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]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 [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]To assess physical fitness the following test are used: Wattmax test
Secondary Outcome Measures:
- Brain-derived neurotrophic factor (BDNF) [ Time Frame: Before and after a 10-week intervention period (chronic and acute) ] [ Designated as safety issue: No ]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 [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]To assess bone mineral density the following test is used: DEXA-scanning
- Thyroidea Stimulating Hormone (TSH) [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples.
- Insulin [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]The level of insulin is assessed in fasting blood samples.
- Glucose [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]The level of glucose is assessed in fasting blood samples
- Lipids [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]The levels of lipids are assessed in fasting blood samples.
- C-reactive-protein [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]The level of c-reactive-protein is assessed in fasting blood samples.
- Seizure frequency [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]Seizure frequency is assessed by a neurologist using a standard seizure calender.
- Blood pressure [ Time Frame: Before and after a 10-week intervention period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 15 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450423
Locations
| Denmark | |
| Epilepsy clinic, Odense University Hospital | Recruiting |
| Odense, Region of Southern Denmark, Denmark, 5000 | |
| Contact: Ioannis Tsiropoulos, consult.ph.d +45 65412438 ioannis.tsiropoulos@ouh.regionsyddanmark.dk | |
| Principal Investigator: Ioannis Tsiropoulos, consult.ph.d | |
| Sub-Investigator: Anne K Thorsen, Stud.scient. | |
| Center of Research in Childhood Health, University of Southern Denmark | Recruiting |
| Odense, Region of Southern Denmark, Denmark, 5000 | |
| Contact: Lars Bo Andersen, Professor +4565504380 lboandersen@health.sdu.dk | |
| Contact: Karsten Froberg, Ass. prof. +4565503457 kfroberg@health.sdu.dk | |
| Sub-Investigator: Karsten Froberg, ass.prof. | |
| Sub-Investigator: Anne K Thorsen, Stud.scient | |
| Principal Investigator: Lars Bo Andersen, Professor | |
Sponsors and Collaborators
Lars Bo Andersen
Investigators
| Principal Investigator: | Lars Bo Andersen, Professor | Center of Research in Childhood Health (RICH), University of Southern Denmark |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lars Bo Andersen, Professor, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01450423 History of Changes |
| Other Study ID Numbers: | S-20110080 |
| Study First Received: | October 9, 2011 |
| Last Updated: | October 9, 2011 |
| Health Authority: | Denmark: Ethics Committee Denmark: Danish Dataprotection Agency |
Keywords provided by University of Southern Denmark:
|
Epilepsy Physical activity Cardio exercise Physical fitness Cognitive function |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Myoclonic Seizures Myoclonic Epilepsy, Juvenile Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013