Physical Excercise Program in Children With Drug-resistant Epilepsy

Not Applicable

• Conditions: Epilepsy in Children
• Interventions: Other: Individualized physical exercise program; Other: NO Individualized physical exercise program

• Registration Number: NCT05323682
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief Summary

Pediatric epilepsy has been described as an age related-condition, and it has a strong impact on childhood quality of life. Psychological symptoms and self-esteem impairment are common facts. Although there are some studies studying the benefits of physical exercise in order to improve seizure control in adults with epilepsy, we have not found studies that support it in pediatric population. Few studieshave reported in childhood some benefits in terms of quality of life, self-esteem and improvement of neuropsychological symptoms. Therefore, it is necessary to use a validated and applicable scale of quality of life in children with epilepsy. Otherwise, findings may be difficult to reproduce

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age 5-14 years

2. Diagnosis of epilepsy (must meet at least one of the following criteria):

   1. At least 2 unprovoked seizures in a period of more than 24 hours
   2. A seizure and probability of future seizures similar to the general risk of recurrence (60% or more) than if the patient had had 2 crises.
   3. Diagnosis of epileptic syndrome.

3. Adequate communication skills with your family.

4. Absence of significant motor limitation.

5. Parents or legal guardians must have given consent to participate in the study.

Exclusion Criteria

b) Exclusion criteria:

1. Failure to meet any of the aforementioned requirements.

2. Failure to complete completely and/or legibly any of the instruments of evaluation. c) Abandonment criteria

3. Failure to deliver the submitted questionnaires in a timely manner. 2. Failure to attend the scheduled appointment to complete the questionnaires control. 3. Not responding to phone calls, e-mails or requests made to make a new appointment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Individualized physical exercise program	Individualized physical exercise program
Control	NO Individualized physical exercise program	No individualized physical exercise program

Primary Outcome Measures

Name	Time	Method
BMI (Body mass index)	Up to 6 months	(kg)/height (m2)
PedsQL (Pediatric Quality of Life Inventory)	Up to 6 months	Likert scale 0-5
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)	Up to 6 months	16 items version
Grip strength	Up to 6 months	Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Tricipital skinfold	Up to 6 months	Thickness of the skinfold located over the triceps muscle
Waist/hip ratio	Up to 6 months	ICC= w/h (cm)
PAQ-C (Physical Activity Questionnaire)	Up to 6 months	Likert scale 0-5
Subscapular skinfold	Up to 6 months	Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Lower extremity strength	Up to 6 months	Standing Long Jump Test
Cardiorespiratory fitness.	Up to 6 months	It was carried out with the Course Navette test (round trip 20 meters)

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain