Clinical trial NCT05323682: Physical Excercise Program in Children With Drug-resistant Epilepsy
Official title: Physical Excercise Program in Children With Drug-resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy in Children
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, experimental, randomized
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: PedsQL (Pediatric Quality of Life Inventory)
timeFrame: Up to 6 months
measure: (Quality of Life in Childhood Epilepsy Questionary, QoLCE)
timeFrame: Up to 6 months
measure: PAQ-C (Physical Activity Questionnaire)
timeFrame: Up to 6 months
measure: BMI (Body mass index)
timeFrame: Up to 6 months
measure: Waist/hip ratio
timeFrame: Up to 6 months
measure: Tricipital skinfold
timeFrame: Up to 6 months
measure: Subscapular skinfold
timeFrame: Up to 6 months
measure: Lower extremity strength
timeFrame: Up to 6 months
measure: Grip strength
timeFrame: Up to 6 months
measure: Cardiorespiratory fitness.
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
References: