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Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT04282460
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Baduanjin practice Behavioral: Regular physical exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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, parents and children agree to participate in the intervention

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282460


Contacts
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Contact: Daqian Zhu, PhD 86-18017590851 zhudaqian2003@163.com
Contact: Mengyao Li, PhD 86-13641745122 miyali2@foxmail.com

Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai Municipal Science and Technology Commission
Investigators
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Study Chair: Daqian Zhu, PhD Department of Psychological Medicine, Children's Hospital of Fudan University
Publications:
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04282460    
Other Study ID Numbers: 19401931200
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
Chinese traditional medicine
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms