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

F

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)

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

Trial contacts and locations

1

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Central trial contact

Salvador Ibañez-Mico, MD

Data sourced from clinicaltrials.gov

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