Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder
|ClinicalTrials.gov Identifier: NCT04282460|
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Behavioral: Baduanjin practice Behavioral: Regular physical exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the Baduanjin intervention or to the regular physical exercise control group.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||A Randomized Clinical Trial of Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder With Hyperactive-Impulsive Symptom|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||March 30, 2022|
Experimental: Baduanjin practice
Baduanjin practice group will be asked to use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months.
Behavioral: Baduanjin practice
Use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months.
Active Comparator: Regular physical exercise
The regular physical exercise group will be asked to take physical exercise for at least half an hour every day in addition to regular physical activities at school.
Behavioral: Regular physical exercise
Take physical exercise for at least half an hour every day in addition to regular physical activities at school.
- Hyperactivity/Impulsivity score change in SNAP-IV scale [ Time Frame: 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).
- Change of Scoring evaluation of the TCM symptoms [ Time Frame: Baseline, 3 months after enrollment ]The TCM symptom scale was developed from the guideline system for traditional Chinese medicine new drug clinical research to evaluate the severity of TCM symptoms of children. This scale include 23 items, each presents one common TCM symptom. Each symptom is rated 1-4 points according to its severity. The total score is calculated by adding the scores of all 23 items. The change of score is calculated by TCM symptoms score after 3 months of enrollment (both Baduanjin practice group and Regular physical exercise group went through 3 months of intervention at this point) minus TCM symptoms score at baseline (enrollment).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282460
|Contact: Daqian Zhu, PhDfirstname.lastname@example.org|
|Contact: Mengyao Li, PhDemail@example.com|
|Study Chair:||Daqian Zhu, PhD||Department of Psychological Medicine, Children's Hospital of Fudan University|