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
  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:


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:
  • Cardio exercise program
  • Cardio training program
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450423

Locations
Denmark
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         
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.         
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:
Epilepsies, Myoclonic
Epilepsy
Myoclonic Epilepsy, Juvenile
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014