NCT01450423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

8 months

First QC Date

October 9, 2011

Last Update Submit

October 9, 2011

Conditions

EpilepsyEpilepsiaEpileptic SeizuresSeizure Disorder

Keywords

EpilepsyPhysical activityCardio exercisePhysical fitnessCognitive function

Outcome Measures

Primary Outcomes (2)

  • 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

    Before and after a 10-week intervention period

  • physical fitness

    To assess physical fitness the following test are used: Wattmax test

    Before and after a 10-week intervention period

Secondary Outcomes (9)

  • Brain-derived neurotrophic factor (BDNF)

    Before and after a 10-week intervention period (chronic and acute)

  • Bone mineral density

    Before and after a 10-week intervention period

  • Thyroidea Stimulating Hormone (TSH)

    Before and after a 10-week intervention period

  • Insulin

    Before and after a 10-week intervention period

  • Glucose

    Before and after a 10-week intervention period

  • +4 more secondary outcomes

Study Arms (2)

Physical activity

EXPERIMENTAL
Behavioral: Physical activity

Control

NO INTERVENTION

Interventions

Physical activityBEHAVIORAL

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.

Also known as: Cardio exercise program, Cardio training program
Physical activity

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Physical handicaps which complicate participation in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center of Research in Childhood Health, University of Southern Denmark

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Epilepsy clinic, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

EpilepsySeizuresMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lars Bo Andersen, Professor

    Center of Research in Childhood Health (RICH), University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2011

First Posted

October 12, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

DK(2)