The Effect of Physical Activity on The Response of Autonomic Nervous System in Individuals With Autism Spectrum Disorders of Different Age Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- ECG measurements
研究概览
简要总结
This study will investigate the effect of physical activity on autism spectrum disorder (ASD) in individuals with ASD of different age groups through measuring the hemodynamic, heart activity and respiratory system parameters.
详细描述
One hundred participants will be included in this study. One hundred typically developed children or control group and one hundred children with ASD group. The age range of participants will be 4 - 18 years old. The participants in both control and ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS). Participants will be excluded if they have any intellectual disability (IQ ≤ 70), co-morbid medical or psychiatric disorders, pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD). They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises. Wechsler Intelligence Scale for Children-Fourth Edition24 will be used to assess the Intelligence Quotient (IQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with ASD group with the age range of participants will be 4 - 18 years old
- •Typically developed children with the age range of participants will be 4 - 18 years old
排除标准
- •Participants will be excluded if they have the following:
- •any intellectual disability (IQ ≤ 70)
- •co-morbid medical or psychiatric disorders.
- •pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD).
- •They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises.
结局指标
主要结局
ECG measurements
时间窗: One minute
A wearable device will be used to collet cardiac ECG data.
Measurements of respiration
时间窗: 5 minutes
Portable Respiratory Monitor will be used to measure the respiratory activity.
Blood pressure measurement
时间窗: 5 minutes
Manual sphygmomanometer will be used to measure the blood pressure.
次要结局
未报告次要终点
研究者
Mohammed Moustafa
Assistant Professor
University of Jazan
