Clinical trial NCT01450423: Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy
Official title: Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epilepsy
Epilepsia
Epileptic Seizures
Seizure Disorder
Keywords: Epilepsy
Physical activity
Cardio exercise
Physical fitness
Cognitive function
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Physical handicaps which complicate participation in physical activity

Primary outcomes:
measure: Cognitive function (concentration and attention)
timeFrame: Before and after a 10-week intervention period
measure: physical fitness
timeFrame: Before and after a 10-week intervention period
Secondary outcomes:
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: Before and after a 10-week intervention period (chronic and acute)
measure: Bone mineral density
timeFrame: Before and after a 10-week intervention period
measure: Thyroidea Stimulating Hormone (TSH)
timeFrame: Before and after a 10-week intervention period
measure: Insulin
timeFrame: Before and after a 10-week intervention period
measure: Glucose
timeFrame: Before and after a 10-week intervention period
measure: Lipids
timeFrame: Before and after a 10-week intervention period
measure: C-reactive-protein
timeFrame: Before and after a 10-week intervention period
measure: Seizure frequency
timeFrame: Before and after a 10-week intervention period
measure: Blood pressure
timeFrame: Before and after a 10-week intervention period
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Center of Research in Childhood Health, University of Southern Denmark
state: Region of Southern Denmark
city: Odense
country: Denmark
facility: Epilepsy clinic, Odense University Hospital
state: Region of Southern Denmark
Study officials:
affiliation: Center of Research in Childhood Health (RICH), University of Southern Denmark
name: Lars Bo Andersen, Professor
role: PRINCIPAL_INVESTIGATOR
References: