Physical Excercise Program in Children With Drug-resistant Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- BMI (Body mass index)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Failure to deliver the submitted questionnaires in a timely manner.
- •Failure to attend the scheduled appointment to complete the questionnaires control.
- •Not responding to phone calls, e-mails or requests made to make a new appointment.
结局指标
主要结局
BMI (Body mass index)
时间窗: Up to 6 months
(kg)/height (m2)
PedsQL (Pediatric Quality of Life Inventory)
时间窗: Up to 6 months
Likert scale 0-5
(Quality of Life in Childhood Epilepsy Questionary, QoLCE)
时间窗: Up to 6 months
16 items version
Grip strength
时间窗: Up to 6 months
Takei Tkk 5401 Digital Hand Dynamometer below the inferior angle of the scapula
Tricipital skinfold
时间窗: Up to 6 months
Thickness of the skinfold located over the triceps muscle
Waist/hip ratio
时间窗: Up to 6 months
ICC= w/h (cm)
PAQ-C (Physical Activity Questionnaire)
时间窗: Up to 6 months
Likert scale 0-5
Subscapular skinfold
时间窗: Up to 6 months
Thickness of localized adipose tissue immediately below the inferior angle of the scapula
Lower extremity strength
时间窗: Up to 6 months
Standing Long Jump Test
Cardiorespiratory fitness.
时间窗: Up to 6 months
It was carried out with the Course Navette test (round trip 20 meters)
次要结局
未报告次要终点