Epilepsy in ChildrenPEPDRENCT05323682
Physical Excercise Program in Children With Drug-resistant Epilepsy
A study testing Individualized physical exercise program and NO Individualized physical exercise program in people with Epilepsy in Children, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Individualized physical exercise program and NO Individualized physical exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Salvador Ibañez-Mico, MD, +34968369647, salvador.ibanez@carm.es
About this study
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
- Being tested
- Individualized physical exercise program, NO Individualized physical exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized physical exercise programOther
An individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband
NO Individualized physical exercise programOther
Usual medication
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Individualized physical exercise program Receives: Other: Individualized physical exercise program |
| Control | Active comparator | No individualized physical exercise program Receives: Other: NO Individualized physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL (Pediatric Quality of Life Inventory)
Likert scale 0-5
Measured: Up to 6 months
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)
16 items version
Measured: Up to 6 months
PAQ-C (Physical Activity Questionnaire)
Likert scale 0-5
Measured: Up to 6 months
BMI (Body mass index)
(kg)/height (m2)
Measured: Up to 6 months
Waist/hip ratio
ICC= w/h (cm)
Measured: Up to 6 months
Tricipital skinfold
Thickness of the skinfold located over the triceps muscle
Measured: Up to 6 months
Subscapular skinfold
Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Measured: Up to 6 months
Lower extremity strength
Standing Long Jump Test
Measured: Up to 6 months
Grip strength
Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Measured: Up to 6 months
Cardiorespiratory fitness.
It was carried out with the Course Navette test (round trip 20 meters)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, experimental, randomized
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323682
- Sponsor's protocol ID
- IMIB SIM
- Acronym
- PEPDRE
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Excercise Program in Children With Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT05323682
- Acronym / sponsor ID
- PEPDRE / IMIB SIM
- Conditions
- Epilepsy in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, experimental, randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Individualized physical exercise programIndividualized physical exercise program |
| Control | Active comparator | Other: NO Individualized physical exercise programNo individualized physical exercise program |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 5-14 years
- Diagnosis of epilepsy (must meet at least one of the following criteria):
- Adequate communication skills with your family.
- Absence of significant motor limitation.
- Parents or legal guardians must have given consent to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized physical exercise programAn individualized physical exercise program was programmed, monitored remotely by e-mail or the use of an activity wristband | Other | Experimental |
| NO Individualized physical exercise programUsual medication | Other | Control |
Primary outcome
PedsQL (Pediatric Quality of Life Inventory)
Time frame: Up to 6 months
Likert scale 0-5
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)
Time frame: Up to 6 months
16 items version
PAQ-C (Physical Activity Questionnaire)
Time frame: Up to 6 months
Likert scale 0-5
BMI (Body mass index)
Time frame: Up to 6 months
(kg)/height (m2)
Waist/hip ratio
Time frame: Up to 6 months
ICC= w/h (cm)
Tricipital skinfold
Time frame: Up to 6 months
Thickness of the skinfold located over the triceps muscle
Subscapular skinfold
Time frame: Up to 6 months
Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Lower extremity strength
Time frame: Up to 6 months
Standing Long Jump Test
Grip strength
Time frame: Up to 6 months
Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Cardiorespiratory fitness.
Time frame: Up to 6 months
It was carried out with the Course Navette test (round trip 20 meters)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized physical exercise program and NO Individualized physical exercise program in people with Epilepsy in Children, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salvador Ibañez-Mico, MD (34968369647, salvador.ibanez@carm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PedsQL (Pediatric Quality of Life Inventory) (time frame: Up to 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.