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| Name | Class |
|---|---|
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baduanjin practice | Behavioral | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daqian Zhu, PhD | Department of Psychological Medicine, Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21299297 | Background | 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. | |
| 24309300 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2022 | Feb 26, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2021 | Oct 26, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
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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.
| Regular physical exercise | Behavioral | Take physical exercise for at least half an hour every day in addition to regular physical activities at school. |
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| Baseline, 3 months after enrollment |
| 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. |
| 23084704 | Background | 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. |
| 23467962 | Background | 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. |