NCT04282460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 24, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

March 15, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

February 21, 2020

Last Update Submit

March 13, 2023

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Chinese traditional medicine

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 3 months after enrollment

Secondary Outcomes (1)

  • Change of Scoring evaluation of the TCM symptoms

    Baseline, 3 months after enrollment

Study Arms (2)

Baduanjin practice

EXPERIMENTAL

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

Regular physical exercise

ACTIVE COMPARATOR

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

Interventions

Baduanjin practiceBEHAVIORAL

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.

Baduanjin practice
Regular physical exerciseBEHAVIORAL

Take physical exercise for at least half an hour every day in addition to regular physical activities at school.

Regular physical exercise

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (4)

  • 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.

    PMID: 21299297BACKGROUND

  • 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.

    PMID: 24309300BACKGROUND

  • 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.

    PMID: 23084704BACKGROUND

  • 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.

    PMID: 23467962BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Daqian Zhu, PhD

    Department of Psychological Medicine, Children's Hospital of Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 24, 2020

Study Start

October 24, 2020

Primary Completion

November 30, 2022

Study Completion

January 30, 2023

Last Updated

March 15, 2023

Record last verified: 2023-01

Locations

CN(1)