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Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy (EFA)

Primary Purpose

Epilepsy, Epilepsia, Epileptic Seizures

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Lars Bo Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epilepsy focused on measuring Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Physical handicaps which complicate participation in physical activity

Sites / Locations

  • Center of Research in Childhood Health, University of Southern DenmarkRecruiting
  • Epilepsy clinic, Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical activity

Control

Arm Description

Outcomes

Primary Outcome Measures

Cognitive function (concentration and attention)
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
To assess physical fitness the following test are used: Wattmax test

Secondary Outcome Measures

Brain-derived neurotrophic factor (BDNF)
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
To assess bone mineral density the following test is used: DEXA-scanning
Thyroidea Stimulating Hormone (TSH)
The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples.
Insulin
The level of insulin is assessed in fasting blood samples.
Glucose
The level of glucose is assessed in fasting blood samples
Lipids
The levels of lipids are assessed in fasting blood samples.
C-reactive-protein
The level of c-reactive-protein is assessed in fasting blood samples.
Seizure frequency
Seizure frequency is assessed by a neurologist using a standard seizure calender.
Blood pressure

Full Information

First Posted
October 9, 2011
Last Updated
October 9, 2011
Sponsor
Lars Bo Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT01450423
Brief Title
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy
Acronym
EFA
Official Title
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Bo Andersen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Epilepsia, Epileptic Seizures, Seizure Disorder
Keywords
Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Cardio exercise program, Cardio training program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive function (concentration and attention)
Description
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
Time Frame
Before and after a 10-week intervention period
Title
physical fitness
Description
To assess physical fitness the following test are used: Wattmax test
Time Frame
Before and after a 10-week intervention period
Secondary Outcome Measure Information:
Title
Brain-derived neurotrophic factor (BDNF)
Description
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.
Time Frame
Before and after a 10-week intervention period (chronic and acute)
Title
Bone mineral density
Description
To assess bone mineral density the following test is used: DEXA-scanning
Time Frame
Before and after a 10-week intervention period
Title
Thyroidea Stimulating Hormone (TSH)
Description
The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples.
Time Frame
Before and after a 10-week intervention period
Title
Insulin
Description
The level of insulin is assessed in fasting blood samples.
Time Frame
Before and after a 10-week intervention period
Title
Glucose
Description
The level of glucose is assessed in fasting blood samples
Time Frame
Before and after a 10-week intervention period
Title
Lipids
Description
The levels of lipids are assessed in fasting blood samples.
Time Frame
Before and after a 10-week intervention period
Title
C-reactive-protein
Description
The level of c-reactive-protein is assessed in fasting blood samples.
Time Frame
Before and after a 10-week intervention period
Title
Seizure frequency
Description
Seizure frequency is assessed by a neurologist using a standard seizure calender.
Time Frame
Before and after a 10-week intervention period
Title
Blood pressure
Time Frame
Before and after a 10-week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bo Andersen, Professor
Organizational Affiliation
Center of Research in Childhood Health (RICH), University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Research in Childhood Health, University of Southern Denmark
City
Odense
State/Province
Region of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Bo Andersen, Professor
Phone
+4565504380
Email
lboandersen@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Karsten Froberg, Ass. prof.
Phone
+4565503457
Email
kfroberg@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Karsten Froberg, ass.prof.
First Name & Middle Initial & Last Name & Degree
Anne K Thorsen, Stud.scient
First Name & Middle Initial & Last Name & Degree
Lars Bo Andersen, Professor
Facility Name
Epilepsy clinic, Odense University Hospital
City
Odense
State/Province
Region of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Tsiropoulos, consult.ph.d
Phone
+45 65412438
Email
ioannis.tsiropoulos@ouh.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Ioannis Tsiropoulos, consult.ph.d
First Name & Middle Initial & Last Name & Degree
Anne K Thorsen, Stud.scient.

12. IPD Sharing Statement

Links:
URL
http://www.sdu.dk/om_sdu/institutter_centre/iob_idraet_og_biomekanik
Description
Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

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Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy

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