Physical Excercise Program in Children With Drug-resistant Epilepsy (PEPDRE)

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status: Enrolling

Conditions: Epilepsy in Children

Treatments: Other: Individualized physical exercise program; Other: NO Individualized physical exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05323682

IMIB SIM

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Experimental

Experimental group

Description:

Individualized physical exercise program

Treatment:

Other: Individualized physical exercise program

Control

Active Comparator group

Description:

No individualized physical exercise program

Treatment:

Other: NO Individualized physical exercise program