EpilepsyPhase 2EFANCT01450423
Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy
A Phase 2 study testing Physical activity in people with Epilepsy and Epilepsia, run by Lars Bo Andersen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Epilepsy, Epilepsia, Epileptic Seizures
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 15-50
- Resident: Fyen, Denmark
- Epileptic syndrome: Juvenile Myoclonic Epilepsy
Who cannot join
- Physical handicaps which complicate participation in physical activity
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Center of Research in Childhood Health, University of Southern Denmark
Odense, Region Syddanmark, 5000
Lars Bo Andersen, Professor, +4565504380, lboandersen@health.sdu.dk
Karsten Froberg, Ass. prof., +4565503457, kfroberg@health.sdu.dk
- Recruiting
Epilepsy clinic, Odense University Hospital
Odense, Region Syddanmark, 5000
Ioannis Tsiropoulos, consult.ph.d, +45 65412438, ioannis.tsiropoulos@ouh.regionsyddanmark.dk
Ioannis Tsiropoulos, consult.ph.d
About this study
Official title: 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.
Read more
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.
- Conditions
- Epilepsy, Epilepsia, Epileptic Seizures, Seizure Disorder
- Being tested
- Physical activity
- Keywords
- Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function
- Medical subject headings
- Epilepsy, Seizures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Cardio exercise program, Cardio training program
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Not described Receives: Behavioral: Physical activity |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and after a 10-week intervention period
physical fitness
To assess physical fitness the following test are used: Wattmax test
Measured: Before and after a 10-week intervention period
Secondary outcomes (9)
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.
Measured: Before and after a 10-week intervention period (chronic and acute)
Bone mineral density
To assess bone mineral density the following test is used: DEXA-scanning
Measured: Before and after a 10-week intervention period
Thyroidea Stimulating Hormone (TSH)
The level of serum Thyroidea Stimulating Hormone (TSH) is assessed in fasting blood samples.
Measured: Before and after a 10-week intervention period
Insulin
The level of insulin is assessed in fasting blood samples.
Measured: Before and after a 10-week intervention period
Glucose
The level of glucose is assessed in fasting blood samples
Measured: Before and after a 10-week intervention period
Lipids
The levels of lipids are assessed in fasting blood samples.
Measured: Before and after a 10-week intervention period
C-reactive-protein
The level of c-reactive-protein is assessed in fasting blood samples.
Measured: Before and after a 10-week intervention period
Seizure frequency
Seizure frequency is assessed by a neurologist using a standard seizure calender.
Measured: Before and after a 10-week intervention period
Blood pressure
Measured: Before and after a 10-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Bo Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Bo Andersen, University of Southern Denmark
- Investigators
- Lars Bo Andersen, Professor, Principal investigator, Center of Research in Childhood Health (RICH), University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450423
- Sponsor's protocol ID
- S-20110080
- Acronym
- EFA
- Status last verified
- Oct 2011
- First submitted
- 9 Oct 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise in Subjects With Juvenile Myoclonic Epilepsy Aged 15-50: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01450423
- Acronym / sponsor ID
- EFA / S-20110080
- Conditions
- Epilepsy, Epilepsia, Epileptic Seizures, Seizure Disorder
- Keywords
- Epilepsy, Physical activity, Cardio exercise, Physical fitness, Cognitive function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lars Bo AndersenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activity |
| Control | No intervention | – |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 15-50
- Resident: Fyen, Denmark
- Epileptic syndrome: Juvenile Myoclonic Epilepsy
Key exclusion criteria (1 listed)
- Physical handicaps which complicate participation in physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Cardio exercise program, Cardio training programParticipation 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. | Behavioural | Physical activity |
Primary outcome
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
physical fitness
Time frame: Before and after a 10-week intervention period
To assess physical fitness the following test are used: Wattmax test
9 secondary outcomes
Brain-derived neurotrophic factor (BDNF)
Time frame: Before and after a 10-week intervention period (chronic and acute)
Bone mineral density
Time frame: Before and after a 10-week intervention period
Thyroidea Stimulating Hormone (TSH)
Time frame: Before and after a 10-week intervention period
Insulin
Time frame: Before and after a 10-week intervention period
Glucose
Time frame: Before and after a 10-week intervention period
Lipids
Time frame: Before and after a 10-week intervention period
C-reactive-protein
Time frame: Before and after a 10-week intervention period
Seizure frequency
Time frame: Before and after a 10-week intervention period
Blood pressure
Time frame: Before and after a 10-week intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Institute of Sports Science and Clinical Biomechanics, University of Southern DenmarkLink provided by the sponsor.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Center of Research in Childhood Health, University of Southern Denmark
Odense, Denmark
Epilepsy clinic, Odense University Hospital
Odense, Denmark
Lars Bo Andersen, Professor principal investigator
Center of Research in Childhood Health (RICH), University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical activity in people with Epilepsy and Epilepsia, run by Lars Bo Andersen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (concentration and attention) (time frame: Before and after a 10-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.