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Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baduanjin practice
Regular physical exercise
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Chinese traditional medicine

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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,Zhejiang province and Jiangsu province, 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

Sites / Locations

  • Children's hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baduanjin practice

Regular physical exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hyperactivity/Impulsivity score change in SNAP-IV scale
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

Change of Scoring evaluation of the TCM symptoms
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).

Full Information

First Posted
February 21, 2020
Last Updated
March 13, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Municipal Science and Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04282460
Brief Title
Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder
Official Title
A Randomized Clinical Trial of Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder With Hyperactive-Impulsive Symptom
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Municipal Science and Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Chinese traditional medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular physical exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin practice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regular physical exercise
Intervention Description
Take physical exercise for at least half an hour every day in addition to regular physical activities at school.
Primary Outcome Measure Information:
Title
Hyperactivity/Impulsivity score change in SNAP-IV scale
Description
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).
Time Frame
Baseline, 3 months after enrollment
Secondary Outcome Measure Information:
Title
Change of Scoring evaluation of the TCM symptoms
Description
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).
Time Frame
Baseline, 3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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,Zhejiang province and Jiangsu province, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daqian Zhu, PhD
Organizational Affiliation
Department of Psychological Medicine, Children's Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21299297
Citation
Davis CL, Tomporowski PD, McDowell JE, Austin BP, Miller PH, Yanasak NE, Allison JD, Naglieri JA. Exercise improves executive function and achievement and alters brain activation in overweight children: a randomized, controlled trial. Health Psychol. 2011 Jan;30(1):91-8. doi: 10.1037/a0021766.
Results Reference
background
PubMed Identifier
24309300
Citation
Drollette ES, Scudder MR, Raine LB, Moore RD, Saliba BJ, Pontifex MB, Hillman CH. Acute exercise facilitates brain function and cognition in children who need it most: an ERP study of individual differences in inhibitory control capacity. Dev Cogn Neurosci. 2014 Jan;7:53-64. doi: 10.1016/j.dcn.2013.11.001. Epub 2013 Nov 16.
Results Reference
background
PubMed Identifier
23084704
Citation
Pontifex MB, Saliba BJ, Raine LB, Picchietti DL, Hillman CH. Exercise improves behavioral, neurocognitive, and scholastic performance in children with attention-deficit/hyperactivity disorder. J Pediatr. 2013 Mar;162(3):543-51. doi: 10.1016/j.jpeds.2012.08.036. Epub 2012 Oct 17.
Results Reference
background
PubMed Identifier
23467962
Citation
Verburgh L, Konigs M, Scherder EJ, Oosterlaan J. Physical exercise and executive functions in preadolescent children, adolescents and young adults: a meta-analysis. Br J Sports Med. 2014 Jun;48(12):973-9. doi: 10.1136/bjsports-2012-091441. Epub 2013 Mar 6.
Results Reference
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Ba Duan Jin in Treatment of Attention Deficit Hyperactivity Disorder

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