Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)

October 9, 2011 updated by: Lars Bo Andersen

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Region of Southern Denmark
      • Odense, Region of Southern Denmark, Denmark, 5000
        • Recruiting
        • Center of Research in Childhood Health, University of Southern Denmark
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Karsten Froberg, ass.prof.
        • Sub-Investigator:
          • Anne K Thorsen, Stud.scient
        • Principal Investigator:
          • Lars Bo Andersen, Professor
      • Odense, Region of Southern Denmark, Denmark, 5000
        • Recruiting
        • Epilepsy clinic, Odense University Hospital
        • Contact:
        • Principal Investigator:
          • Ioannis Tsiropoulos, consult.ph.d
        • Sub-Investigator:
          • Anne K Thorsen, Stud.scient.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Physical handicaps which complicate participation in physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before and after a 10-week intervention period
physical fitness
Time Frame: Before and after a 10-week intervention period
To assess physical fitness the following test are used: Wattmax test
Before and after a 10-week intervention period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lars Bo Andersen, Professor, Center of Research in Childhood Health (RICH), University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

October 9, 2011

First Submitted That Met QC Criteria

October 9, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 9, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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