Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Southern Denmark.
Recruitment status was  Recruiting
Sponsor:
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

October 9, 2011
October 9, 2011
September 2011
May 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Epilepsy
  • Epilepsia
  • Epileptic Seizures
  • Seizure Disorder
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
  • Experimental: Physical activity
    Intervention: Behavioral: Physical activity
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Physical handicaps which complicate participation in physical activity
Both
15 Years to 50 Years
No
Denmark
 
NCT01450423
S-20110080
Not Provided
Lars Bo Andersen, University of Southern Denmark
Lars Bo Andersen
Not Provided
Principal Investigator: Lars Bo Andersen, Professor Center of Research in Childhood Health (RICH), University of Southern Denmark
University of Southern Denmark
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP