A Randomized Clinical Trial of Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder With Hyperactive-Impulsive Symptom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hyperactivity/Impulsivity score change in SNAP-IV scale
研究概览
简要总结
This study is designed to test if Baduanjin training can reduce the hyperactive-impulsive symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine excise. Investigators will also evaluate if the Baduanjin training will positively affect Chinese Traditional Medicine (TCM) symptoms compared to controls and if these impacts are related to the change of the executive function.
详细描述
ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings. The prevalence in China is estimated to be 6.26%. From the point of Chinese Traditional Medicine (TCM), ADHD can be divided into 4 categories according to the symptom differentiation in TCM.
Aerobic exercise is known to improve executive function (EF) performance, which is known as the core deficit of ADHD, therefore reduce ADHD symptoms. Aerobic exercise with the component of self-control and development of character is reported to improve EF.
Baduanjin is one of the aerobic exercises that has been handed down since the northern song dynasty, serving as Chinese physical and breathing exercises. The eight movements of Baduanjin are required to be gentle, slow, elastic and appropriate which not only require the practitioner to control physical activity but also require a combination of cognitive activities. Researchers found that Baduanjin has a positive protective effect on cognitive function such as selective attention in patients with mild cognitive impairment adults.
Therefore, investigators designed the Baduanjin training system. This is a combination of a physical and cognitive training program and a video game with a motivation system, interesting and engaging for children with ADHD to practice on.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The medical treatment of participants will be given by a doctor who does not know the study group of the patient. The investigator of the primary outcome and secondary outcome will also be unaware of the grouping of the patient. One psychiatrist blind of grouping will ask parents about the ADHD Hyperactivity/Impulsivity symptom of their children and rate it with SNAP-IV Hyperactivity/Impulsivity score. Another Chinese traditional medical doctor blind of grouping will evaluate the severity of traditional Chinese medicine symptoms of children and rate it with TCM symptom scale.
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ADHD, Combined Presentation or Predominantly Hyperactive-Impulsive Presentation
- •Doctor rated SNAP-IV Hyperactivity/Impulsivity score≥12
- •Full-Scale Intelligence Quotient>=80 (Wechsler intelligence scale for children-IV)
- •Resident in Shanghai，Zhejiang province and Jiangsu province, parents and children agree to participate in the intervention
排除标准
- •Using psychiatric medication other than methylphenidate
- •Attending any other type of regular physical exercises except the gym class in school during the intervention period
- •Accepting any type of psychological treatment during the intervention
- •Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
- •Attending any other clinical research at the same time
结局指标
主要结局
Hyperactivity/Impulsivity score change in SNAP-IV scale
时间窗: Baseline, 3 months after enrollment
The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the 9-item-Hyperactivity/Impulsivity subscale for the evaluation of change in ADHD Hyperactivity/Impulsivity symptom in children. The score of Hyperactivity/Impulsivity subscale is calculated by adding the 9 items, the score will range from 0 to 27. The change of score is calculated by Hyperactivity/Impulsivity score at 3 months enrollment (both Baduanjin practice group and Regular physical exercise group went through 3 months of intervention at this point) minus Hyperactivity/Impulsivity score at baseline (enrollment).
次要结局
- Change of Scoring evaluation of the TCM symptoms(Baseline, 3 months after enrollment)