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

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy in Children
• Intervention / Treatment: Other: Individualized physical exercise program; Other: NO Individualized physical exercise program

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvador Ibañez-Mico, MD; Phone Number: 34968369647; Email: salvador.ibanez@carm.es

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Clínico Universitario Virgen de la Arrixaca
    • Contact: Salvador Ibañez-Mico, MD; Phone Number: +34968369647; Email: salvador.ibanez@carm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: IMIB SIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No