Effects of Exercise on Functional Performance, BDNF, Executive Functions and Sleep Quality in Children with Epilepsy

NCT06677034 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KAEK-08
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Epilepsy

Keywords

epilepsy; BDNF; child; functional performance; sleep quality; executive functions

Outcome Measures

Primary Outcomes (5)

• bdnf

  The change in BDNF levels in the blood will be checked before and after 3 months of exercise.

  3 month

• functional performance

  will be evaluated with timed up and walk test .Changes will be examined before and after 3 months of exerciseTime

  3 month

• functional performance

  will be evaluated stair climbing test . Changes will be examined before and after 3 months of exerciseTime

  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

  3 month

• executive function

  will be evaluated with the brief parent form

  3 month

Study Arms (2)

control

NO INTERVENTION

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

Other: Exercise

Interventions

Exercise OTHER

Mobile Game-Based Exercise Training

intervention

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

MeSH Terms

Conditions

Epilepsy; Sleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Berçem Sinanoğlu

CONTACT

05075244957; bercemsinanoglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC. PROF. DR.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 6, 2024
• Study Start: January 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: December 23, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share