Physical Excercise Program in Children With Drug-resistant Epilepsy

NCT05323682 | Unknown

• 1 other identifier: IMIB SIM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy in Children

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

Individualized physical exercise program

Other: Individualized physical exercise program

Control

ACTIVE COMPARATOR

No individualized physical exercise program

Other: NO Individualized physical exercise program

Interventions

Individualized physical exercise program OTHER

An individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband

Experimental

NO Individualized physical exercise program OTHER

Usual medication

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Failure to meet any of the aforementioned requirements.
• Failure to complete completely and/or legibly any of the instruments of evaluation. c) Abandonment criteria
• \. 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Central Study Contacts

Salvador Ibañez-Mico, MD

CONTACT

34968369647; salvador.ibanez@carm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, experimental, randomized

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 12, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: August 30, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)