Back to resultsPhysical Excercise Program in Children With Drug-resistant Epilepsy (PEPDRE)
Primary Purpose
Epilepsy in Children
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Individualized physical exercise program
NO Individualized physical exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy in Children
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
b) Exclusion criteria:
- Failure to meet any of the aforementioned requirements.
- 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.
Sites / Locations
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Individualized physical exercise program
No individualized physical exercise program
Outcomes
Primary Outcome Measures
PedsQL (Pediatric Quality of Life Inventory)
Likert scale 0-5
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)
16 items version
PAQ-C (Physical Activity Questionnaire)
Likert scale 0-5
BMI (Body mass index)
(kg)/height (m2)
Waist/hip ratio
ICC= w/h (cm)
Tricipital skinfold
Thickness of the skinfold located over the triceps muscle
Subscapular skinfold
Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Lower extremity strength
Standing Long Jump Test
Grip strength
Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Cardiorespiratory fitness.
It was carried out with the Course Navette test (round trip 20 meters)
Secondary Outcome Measures
Full Information
NCT ID
NCT05323682
First Posted
April 1, 2022
Last Updated
April 12, 2022
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT05323682
Brief Title
Physical Excercise Program in Children With Drug-resistant Epilepsy
Acronym
PEPDRE
Official Title
Physical Excercise Program in Children With Drug-resistant Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, experimental, randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Individualized physical exercise program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No individualized physical exercise program
Intervention Type
Other
Intervention Name(s)
Individualized physical exercise program
Intervention Description
An individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband
Intervention Type
Other
Intervention Name(s)
NO Individualized physical exercise program
Intervention Description
Usual medication
Primary Outcome Measure Information:
Title
PedsQL (Pediatric Quality of Life Inventory)
Description
Likert scale 0-5
Time Frame
Up to 6 months
Title
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)
Description
16 items version
Time Frame
Up to 6 months
Title
PAQ-C (Physical Activity Questionnaire)
Description
Likert scale 0-5
Time Frame
Up to 6 months
Title
BMI (Body mass index)
Description
(kg)/height (m2)
Time Frame
Up to 6 months
Title
Waist/hip ratio
Description
ICC= w/h (cm)
Time Frame
Up to 6 months
Title
Tricipital skinfold
Description
Thickness of the skinfold located over the triceps muscle
Time Frame
Up to 6 months
Title
Subscapular skinfold
Description
Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Time Frame
Up to 6 months
Title
Lower extremity strength
Description
Standing Long Jump Test
Time Frame
Up to 6 months
Title
Grip strength
Description
Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Time Frame
Up to 6 months
Title
Cardiorespiratory fitness.
Description
It was carried out with the Course Navette test (round trip 20 meters)
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
b) Exclusion criteria:
Failure to meet any of the aforementioned requirements.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salvador Ibañez-Mico, MD
Phone
34968369647
Email
salvador.ibanez@carm.es
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador Ibañez-Mico, MD
Phone
+34968369647
Email
salvador.ibanez@carm.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Excercise Program in Children With Drug-resistant Epilepsy
We'll reach out to this number within 24 hrs