EpilepsyBDNFNCT06677034
Effects of Exercise on Functional Performance, BDNF, Executive Functions and Sleep Quality in Children with Epilepsy
A study testing Exercise in people with Epilepsy, run by Inonu University.
Trial summary
According to the definition of the International League for the Control of Epilepsy, a seizure is the emergence of temporary symptoms and/or findings as a result of abnormal, excessive and simultaneous stimulation of neurons in the brain. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with G40 (epilepsy) between the ages of 6-10
- Epileptic seizures under control
- No additional neuromuscular, psychiatric, orthopedic, cognitive function, etc. problems
- Presence of a device that will provide regular mobile application access
- Ability to use the mobile application
- Volunteering of the family and child to participate in the study
Who cannot join
- Having a condition that prevents performing exercises and tests
- Having a psychosocial problem that prevents adaptation to the study
- Having an auditory, visual, etc. disability
- Having a seizure in the last 6 months
- Having a regular exercise or sports habit
- Other diseases that will cause difficulty in perceiving the instructions given to the person
- Patients who do not give informed consen
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Mobile Game-Based Exercise Training on Functional Performance, Brain-Derived Neurotrophic Factor, Executive Functions and Sleep Quality in Children with Epilepsy
According to the definition of the International League for the Control of Epilepsy, a seizure is the emergence of temporary symptoms and/or findings as a result of abnormal, excessive and simultaneous stimulation of neurons in the brain. Epilepsy is a state of being prone to recurrent seizures; epilepsy is at least two seizures that occur without a cause that can be shown at the time and recur within more than 24 hours. Approximately one in 150 children is diagnosed with epilepsy in the first 10 years of their life, and the highest incidence rate is seen in infancy. A study conducted on individuals with epilepsy has indicated that exercise can create positive neuronal changes and reduce damage. In this context, 50 children with epilepsy between the ages of 6 and 10 who are being followed up at the Department of Child Neurology at Malatya Education and Research Hospital will be selected for the study and will be divided into experimental and control groups. In the randomized controlled study, the experimental group will be given mobile game-based exercise training, while the control group will not receive any intervention. Functional performance, BDNF, executive functions and sleep quality will be assessed in both groups at the beginning of the exercise and after the completion of the 12-week mobile game-based exercise intervention. Functional performance assessment will be performed using the timed up and walk test and the timed stair ascent and descent test. BDNF levels will be determined from the blood. The BRIEF-Parent Form will be used to assess executive functions. The Childhood Sleep Disorder Scale will be used for sleep quality. The aim of the study is to evaluate the effects of mobile game-based exercise training on functional performance, brain-derived neurotrophic factor, executive functions and sleep quality in children with epilepsy.
Read the detailed description
According to the definition of the International League Against Epilepsy, a seizure is the emergence of temporary signs and/or symptoms as a result of abnormal, excessive and simultaneous stimulation of neurons in the brain. Epilepsy is a state of being prone to recurrent seizures; epilepsy is at least two seizures that occur without a cause that can be demonstrated at the time and recur within more than 24 hours. Approximately one in 150 children is diagnosed with epilepsy in the first 10 years of their life, with the highest incidence rate seen in infancy. Recent studies conducted in different populations in Turkey have indicated that the incidence of epilepsy in children and adolescents is between 20 per 100,000 and 124 per 100,000. Families of children with epilepsy report high levels of stress (45%), depression (46%) and anxiety (56%). The concept of gamification is based on the application of "game design elements in a non-game context" to motivate participation. Many studies have reported the positive effects of game-based education in children. Through play, the child's psychomotor skills, strength, reaction and attention are increased, control of large and small muscles is taken under control and balance, flexibility and agility are provided in movements.
Studies on the subject show that exercise can create positive neuronal changes in individuals with epilepsy and reduce damage. Regular exercise is associated with changes in neurotransmitter levels, glial cell volume, expression of endogenous neurotrophic factors and increased neurogenesis. Considering these neurobiological effects of exercise, physical activity has been shown to have beneficial effects on neurodegenerative diseases.
Functional performance refers to certain activities and behaviors that individuals can perform at a certain level in daily life. It is known that functional performance is affected in children with epilepsy. When the literature is examined, it has been seen that children and adolescents with epilepsy but without additional disabilities have surprisingly high motor problems, especially in the areas of reaction speed, balance and coordination.
Brain-derived neurotrophic factor (BDNF) belongs to the neurotrophin family, which are growth factors that have trophic effects on neurons. BDNF is the most widely distributed neurotrophin in the central nervous system and is highly expressed in the prefrontal cortex and hippocampus. It is generally accepted that BDNF plays a role in synaptic plasticity by regulating presynaptic and postsynaptic transmission. There are studies showing that BDNF levels are altered in individuals with epilepsy.
Sleep disorders are more common in children with epilepsy than in the general population. Due to the bidirectional relationship between epilepsy and sleep disorders, it is extremely important to evaluate sleep disorders in individuals with epilepsy. At the same time, behavioral changes, cognitive problems, and learning difficulties (mostly attention problems and hyperactivity) are more common in children with epilepsy, 24-66% more than in the general population; these changes are strongly associated with insomnia or excessive sleepiness.
Epilepsy in childhood is characterized as a chronic medical disease with a characteristic behavioral and cognitive phenotype that includes impaired executive functions and attention-related deficits. Studies have shown that executive functions are affected in children with epilepsy. In the literature, the sample group of studies on the effects of exercise in epilepsy is usually adults. In this case, data on the effects of exercise in children with epilepsy are quite limited. This study will evaluate the effects of exercise training on functional performance, brain-derived neurotrophic factor, executive functions and sleep quality in children with epilepsy and will provide data and contributions to fill this gap in the literature.
- Conditions
- Epilepsy
- Being tested
- Exercise
- Keywords
- epilepsy, BDNF, child, functional performance, sleep quality, executive functions
- Medical subject headings
- Epilepsy, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Mobile Game-Based Exercise Training
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| intervention | Experimental | Consent will be obtained from the volunteer children and parents and a WhatsApp group will be established. Parents will be asked to fill out sociodemographic forms about themselves and the child. Students whose parents have given their consent will be included in the study and a mobile game-based exercise program will be started. Each online animated game-based exercise program will be supervised by a researcher physiotherapist. Game-based exercise program sessions with animated characters will be planned for 12 weeks/3 days a week/30 minutes. Fatigue perceptions will be assessed with the Modified Borg Scale after each exercise. Children who show any symptoms will take a break from the session. The first assessment will be made before the sessions start and the final assessment will be made after the 12-week exercise program.
Game-based exercise program content:
Warm-up Exercise Program Warm-up exercise training; fun and interesting animated game-based exercise that will allow the hea Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
bdnf
The change in BDNF levels in the blood will be checked before and after 3 months of exercise.
Measured: 3 month
functional performance
will be evaluated with timed up and walk test .Changes will be examined before and after 3 months of exerciseTime
Measured: 3 month
functional performance
will be evaluated stair climbing test . Changes will be examined before and after 3 months of exerciseTime
Measured: 3 month
sleep quality
Will be evaluated with Children's Sleep Disorder Scale.On a five-point Likert-type scale, 1 corresponds to 'never', while 5 corresponds to 'always (daily)'. Higher scores indicate more acute sleep disturbances
Measured: 3 month
executive function
will be evaluated with the brief parent form
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion23 Dec 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Özdemir, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677034
- Sponsor's protocol ID
- 2024-KAEK-08
- Acronym
- BDNF
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Game-Based Exercise Training on Functional Performance, Brain-Derived Neurotrophic Factor, Executive Functions and Sleep Quality in Children with Epilepsy
- ClinicalTrials.gov ID
- NCT06677034
- Acronym / sponsor ID
- BDNF / 2024-KAEK-08
- Conditions
- Epilepsy
- Keywords
- epilepsy, BDNF, child, functional performance, sleep quality, executive functions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- 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.
According to the definition of the International League for the Control of Epilepsy, a seizure is the emergence of temporary symptoms and/or findings as a result of abnormal, excessive and simultaneous stimulation of neurons in the brain. Epilepsy is a state of being prone to recurrent seizures; epilepsy is at least two seizures that occur without a cause that can be shown at the time and recur within more than 24 hours. Approximately one in 150 children is diagnosed with epilepsy in the first 10 years of their life, and the highest incidence rate is seen in infancy. A study conducted on individuals with epilepsy has indicated that exercise can create positive neuronal changes and reduce damage. In this context, 50 children with epilepsy between the ages of 6 and 10 who are being followed up at the Department of Child Neurology at Malatya Education and Research Hospital will be selected for the study and will be divided into experimental and control groups. In the randomized controlled study, the experimental group will be given mobile game-based exercise training, while the control group will not receive any intervention. Functional performance, BDNF, executive functions and sleep quality will be assessed in both groups at the beginning of the exercise and after the completion of the 12-week mobile game-based exercise intervention. Functional performance assessment will be performed using the timed up and walk test and the timed stair ascent and descent test. BDNF levels will be determined from the blood. The BRIEF-Parent Form will be used to assess executive functions. The Childhood Sleep Disorder Scale will be used for sleep quality. The aim of the study is to evaluate the effects of mobile game-based exercise training on functional performance, brain-derived neurotrophic factor, executive functions and sleep quality in children with epilepsy.
Detailed description
According to the definition of the International League Against Epilepsy, a seizure is the emergence of temporary signs and/or symptoms as a result of abnormal, excessive and simultaneous stimulation of neurons in the brain. Epilepsy is a state of being prone to recurrent seizures; epilepsy is at least two seizures that occur without a cause that can be demonstrated at the time and recur within more than 24 hours. Approximately one in 150 children is diagnosed with epilepsy in the first 10 years of their life, with the highest incidence rate seen in infancy. Recent studies conducted in different populations in Turkey have indicated that the incidence of epilepsy in children and adolescents is between 20 per 100,000 and 124 per 100,000. Families of children with epilepsy report high levels of stress (45%), depression (46%) and anxiety (56%). The concept of gamification is based on the application of "game design elements in a non-game context" to motivate participation. Many studies have reported the positive effects of game-based education in children. Through play, the child's psychomotor skills, strength, reaction and attention are increased, control of large and small muscles is taken under control and balance, flexibility and agility are provided in movements.
Studies on the subject show that exercise can create positive neuronal changes in individuals with epilepsy and reduce damage. Regular exercise is associated with changes in neurotransmitter levels, glial cell volume, expression of endogenous neurotrophic factors and increased neurogenesis. Considering these neurobiological effects of exercise, physical activity has been shown to have beneficial effects on neurodegenerative diseases.
Functional performance refers to certain activities and behaviors that individuals can perform at a certain level in daily life. It is known that functional performance is affected in children with epilepsy. When the literature is examined, it has been seen that children and adolescents with epilepsy but without additional disabilities have surprisingly high motor problems, especially in the areas of reaction speed, balance and coordination.
Brain-derived neurotrophic factor (BDNF) belongs to the neurotrophin family, which are growth factors that have trophic effects on neurons. BDNF is the most widely distributed neurotrophin in the central nervous system and is highly expressed in the prefrontal cortex and hippocampus. It is generally accepted that BDNF plays a role in synaptic plasticity by regulating presynaptic and postsynaptic transmission. There are studies showing that BDNF levels are altered in individuals with epilepsy.
Sleep disorders are more common in children with epilepsy than in the general population. Due to the bidirectional relationship between epilepsy and sleep disorders, it is extremely important to evaluate sleep disorders in individuals with epilepsy. At the same time, behavioral changes, cognitive problems, and learning difficulties (mostly attention problems and hyperactivity) are more common in children with epilepsy, 24-66% more than in the general population; these changes are strongly associated with insomnia or excessive sleepiness.
Epilepsy in childhood is characterized as a chronic medical disease with a characteristic behavioral and cognitive phenotype that includes impaired executive functions and attention-related deficits. Studies have shown that executive functions are affected in children with epilepsy. In the literature, the sample group of studies on the effects of exercise in epilepsy is usually adults. In this case, data on the effects of exercise in children with epilepsy are quite limited. This study will evaluate the effects of exercise training on functional performance, brain-derived neurotrophic factor, executive functions and sleep quality in children with epilepsy and will provide data and contributions to fill this gap in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| intervention | Experimental | Other: ExerciseConsent will be obtained from the volunteer children and parents and a WhatsApp group will be established. Parents will be asked to fill out sociodemographic forms about themselves and the child. Students whose parents have given their consent will be included in the study and a mobile game-based exercise program will be started. Each online animated game-based exercise program will be supervised by a researcher physiotherapist. Game-based exercise program sessions with animated characters will be planned for 12 weeks/3 days a week/30 minutes. Fatigue perceptions will be assessed with the Modified Borg Scale after each exercise. Children who show any symptoms will take a break from the session. The first assessment will be made before the sessions start and the final assessment will be made after the 12-week exercise program. Game-based exercise program content: Warm-up Exercise Program Warm-up exercise training; fun and interesting animated game-based exercise that will allow the hea |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosed with G40 (epilepsy) between the ages of 6-10
- Epileptic seizures under control
- No additional neuromuscular, psychiatric, orthopedic, cognitive function, etc. problems
- Presence of a device that will provide regular mobile application access
- Ability to use the mobile application
Key exclusion criteria (7 listed)
- Having a condition that prevents performing exercises and tests
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 |
|---|---|---|
| ExerciseMobile Game-Based Exercise Training | Other | intervention |
Primary outcome
bdnf
Time frame: 3 month
The change in BDNF levels in the blood will be checked before and after 3 months of exercise.
functional performance
Time frame: 3 month
will be evaluated with timed up and walk test .Changes will be examined before and after 3 months of exerciseTime
functional performance
Time frame: 3 month
will be evaluated stair climbing test . Changes will be examined before and after 3 months of exerciseTime
sleep quality
Time frame: 3 month
Will be evaluated with Children's Sleep Disorder Scale.On a five-point Likert-type scale, 1 corresponds to 'never', while 5 corresponds to 'always (daily)'. Higher scores indicate more acute sleep disturbances
executive function
Time frame: 3 month
will be evaluated with the brief parent form
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, 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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Epilepsy, run by Inonu University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berçem Sinanoğlu (05075244957, bercemsinanoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bdnf (time frame: 3 month). The study lists 5 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 6 Nov 2024.