Clinical Trial: Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Lars Bo Andersen

Current Primary Outcome:

  • 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
  • physical fitness [ Time Frame: Before and after a 10-week intervention period ]
    To assess physical fitness the following test are used: Wattmax test


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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
  • 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.
  • Insulin [ Time Frame: Before and after a 10-week intervention period ]
    The level of insulin is assessed in fasting blood samples.
  • Glucose [ Time Frame: Before and after a 10-week intervention period ]
    The level of glucose is assessed in fasting blood samples
  • Lipids [ Time Frame: Before and after a 10-week intervention period ]
    The levels of lipids are assessed in fasting blood samples.
  • 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.
  • Seizure frequency [ Time Frame: Before and after a 10-week intervention period ]
    Seizure frequency is assessed by a neurologist using a standard seizure calender.
  • Blood pressure [ Time Frame: Before and after a 10-week intervention period ]


Original Secondary Outcome: Same as current

Information By: University of Southern Denmark

Dates:
Date Received: October 9, 2011
Date Started: September 2011
Date Completion: May 2012
Last Updated: October 9, 2011
Last Verified: October 2011