Physical Excercise Program in Children With Drug-resistant Epilepsy

Study Overview
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Brief Summary
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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

Official Title
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Physical Excercise Program in Children With Drug-resistant Epilepsy

Conditions
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Epilepsy in Children

Intervention / Treatment
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* Other: Individualized physical exercise program
* Other: NO Individualized physical exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 5-14 years Diagnosis of epilepsy (must meet at least one of the following criteria): At least 2 unprovoked seizures in a period of more than 24 hours 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. Diagnosis of epileptic syndrome. Adequate communication skills with your family. Absence of significant motor limitation. Parents or legal guardians must have given consent to participate in the study. Exclusion Criteria: b) Exclusion criteria: Failure to meet any of the aforementioned requirements. Failure to complete completely and/or legibly any of the instruments of evaluation. c) Abandonment criteria 1. 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, experimental, randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Individualized physical exercise program | Other: Individualized physical exercise program<br>* An individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband<br>|
| Active Comparator: Control<br>No individualized physical exercise program | Other: NO Individualized physical exercise program<br>* Usual medication<br>|

What is the study measuring?
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Primary Outcome Measures

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