Physical Excercise Program in Children With Drug-resistant Epilepsy

Epilepsy in Children Clinical Trial

— PEPDRE  

Official title:

Physical Excercise Program in Children With Drug-resistant Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323682
• Other study ID #: IMIB SIM
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: April 2022
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Salvador Ibañez-Mico, MD
• Phone: 34968369647
• Email: salvador.ibanez[@]carm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy in Children

Intervention

Other:
• Individualized physical exercise program
An individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband
• NO Individualized physical exercise program
Usual medication

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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