Effects of Systematic Exercise Training on Core Symptoms, Executive Function and Brain Function in Children With ASD
NCT ID: NCT07104708
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-08-31
2028-06-30
Brief Summary
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Detailed Description
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2. Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis and comorbid conditions.
3. Sample size. This study is a randomized controlled trial. The proposed sample size is based on using the sample size formula, which compares the two sample means, . Where, tα is the standard normal difference corresponding to the level, taking α=0.05 and tα=1.96; tβ is the u value corresponding to the probability β of type II error, taking β=0.10 and tβ=1.28; σ is the estimate of the population standard deviation; δ is the allowable error, the difference between two population means. According to literature review, taking the adjustment ability in executive function as the main observation index, it is calculated that δ/σ =0.84. The sample size of intervention group and control group was 30 children, respectively. Considering the sample loss rate of 15%, the two groups are finally determined to be 35 children respectively.
4. Statistical analysis. SPSS 25.0 software (SPSS Inc) was used for statistical analysis for the scale data, including core symptoms and executive function, and the data were expressed as (M±SD). The scales scores and demographic variables of both groups of children will be compared using independent samples t-tests. Differences between baseline and 1 week and 1 month after exercise will be analysed using a repeated measures F-test. All statistical analyses were conducted with a statistical threshold P-value of \<0.05. The data collected through fNIRS will be performed via NirSpark analysis software. The general linear model (GLM) will be applied to integrate task effects and assess activation in relevant brain regions. To analyze the rsFC of brain in children with ASD before and after the exercise intervention, the FC\_NIRS toolbox is used.
5. Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program) for 12 weeks (5 days/week, 60 minutes/day).
The Child-Parent- Trainer exercise program
The Child-Parent-Trainer exercise program is a 12-week exercise training program, which is based on the sensory and cognitive needs of children with ASD, multiple game forms are integrated to form a multi-sensory intervention model. The exercise program is developed according to the types of exercise recommended in the Exercise Guidelines for Preschool Children of China, including the development of basic motor skills, such as physical movement, posture control, object control; development of important physical qualities, such as agility, balance, coordination. The training program for different age group consists of physical movement items, object control items and limb coordination items. The exercise intensity is moderate.
Control group
The control group received regular physical training courses for 12 weeks (5 days/week, 60 minutes/day).
The regular physical training
The regular physical training courses will last for 12 weeks. It is training in motor skills and fine motor skills. The items include passing the ball, lifting small dumbbells, running, handicrafts, etc. There is no requirement for the intensity of the exercise.
Interventions
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The Child-Parent- Trainer exercise program
The Child-Parent-Trainer exercise program is a 12-week exercise training program, which is based on the sensory and cognitive needs of children with ASD, multiple game forms are integrated to form a multi-sensory intervention model. The exercise program is developed according to the types of exercise recommended in the Exercise Guidelines for Preschool Children of China, including the development of basic motor skills, such as physical movement, posture control, object control; development of important physical qualities, such as agility, balance, coordination. The training program for different age group consists of physical movement items, object control items and limb coordination items. The exercise intensity is moderate.
The regular physical training
The regular physical training courses will last for 12 weeks. It is training in motor skills and fine motor skills. The items include passing the ball, lifting small dumbbells, running, handicrafts, etc. There is no requirement for the intensity of the exercise.
Eligibility Criteria
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Inclusion Criteria
* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for ASD, And hold a certificate of ASD diagnosis issued by a Tertiary A hospital.
* Borderline/normal intelligence or mild intellectual disability.
* No serious behavior or emotional problems.
* Able to simply ask and answer questions.
* Be able to proactively express the need to use the toilet.
* There are no physical impairments that affected participation in physical activities, and participants are able to cooperate to complete the intervention.
* Informed parental consent.
Exclusion Criteria
* Medical conditions that limit the ability to be physically active, such as asthma, epilepsy, heart disease, and the acute phase after a fracture.
* History of head trauma, physical disability, major organ disease, or severe musculoskeletal injury in the past two years.
* Those who have participated in physical exercise regularly within the last 6 months.
* Participants who changed treatment intervention midway after inclusion.
* Unable to cooperate with persistent completion of intervention.
3 Years
9 Years
ALL
No
Sponsors
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Gansu Provincial Maternal and Child Health Care Hospital
OTHER
Chen Li
OTHER
Responsible Party
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Chen Li
Professor, Director
Principal Investigators
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Li Chen, doctor
Role: STUDY_DIRECTOR
Children's Hospital of Chongqing Medical University
yu T Li, Doctor
Role: STUDY_CHAIR
Children's Hospital of Chongqing Medical University
Locations
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Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
Xu G, Strathearn L, Liu B, O'Brien M, Kopelman TG, Zhu J, Snetselaar LG, Bao W. Prevalence and Treatment Patterns of Autism Spectrum Disorder in the United States, 2016. JAMA Pediatr. 2019 Feb 1;173(2):153-159. doi: 10.1001/jamapediatrics.2018.4208.
Demetriou EA, Lampit A, Quintana DS, Naismith SL, Song YJC, Pye JE, Hickie I, Guastella AJ. Autism spectrum disorders: a meta-analysis of executive function. Mol Psychiatry. 2018 May;23(5):1198-1204. doi: 10.1038/mp.2017.75. Epub 2017 Apr 25.
Lippi G, Mattiuzzi C, Sanchis-Gomar F. Updated overview on interplay between physical exercise, neurotrophins, and cognitive function in humans. J Sport Health Sci. 2020 Jan;9(1):74-81. doi: 10.1016/j.jshs.2019.07.012. Epub 2019 Sep 6.
Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.
Chan JS, Deng K, Yan JH. The effectiveness of physical activity interventions on communication and social functioning in autistic children and adolescents: A meta-analysis of controlled trials. Autism. 2021 May;25(4):874-886. doi: 10.1177/1362361320977645. Epub 2020 Dec 11.
Sandbank M, Bottema-Beutel K, Woynaroski T. Intervention Recommendations for Children With Autism in Light of a Changing Evidence Base. JAMA Pediatr. 2021 Apr 1;175(4):341-342. doi: 10.1001/jamapediatrics.2020.4730. No abstract available.
Jia M, Zhang J, Pan J, Hu F, Zhu Z. Benefits of exercise for children and adolescents with autism spectrum disorder: a systematic review and meta-analysis. Front Psychiatry. 2024 Oct 7;15:1462601. doi: 10.3389/fpsyt.2024.1462601. eCollection 2024.
Tao R, Yang Y, Wilson M, Chang JR, Liu C, Sit CHP. Comparative effectiveness of physical activity interventions on cognitive functions in children and adolescents with Neurodevelopmental Disorders: a systematic review and network meta-analysis of randomized controlled trials. Int J Behav Nutr Phys Act. 2025 Jan 13;22(1):6. doi: 10.1186/s12966-024-01702-7.
Chan AS, Sze SL, Siu NY, Lau EM, Cheung MC. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial. PLoS One. 2013 Jul 10;8(7):e68184. doi: 10.1371/journal.pone.0068184. Print 2013.
Toscano CVA, Ferreira JP, Quinaud RT, Silva KMN, Carvalho HM, Gaspar JM. Exercise improves the social and behavioral skills of children and adolescent with autism spectrum disorders. Front Psychiatry. 2022 Dec 22;13:1027799. doi: 10.3389/fpsyt.2022.1027799. eCollection 2022.
Grospretre S, Ruffino C, Derguy C, Gueugneau N. Sport and Autism: What Do We Know so Far? A Review. Sports Med Open. 2024 Oct 3;10(1):107. doi: 10.1186/s40798-024-00765-x.
Zhang F, Roeyers H. Exploring brain functions in autism spectrum disorder: A systematic review on functional near-infrared spectroscopy (fNIRS) studies. Int J Psychophysiol. 2019 Mar;137:41-53. doi: 10.1016/j.ijpsycho.2019.01.003. Epub 2019 Jan 19.
Mazzoni A, Grove R, Eapen V, Lenroot RK, Bruggemann J. The promise of functional near-infrared spectroscopy in autism research: What do we know and where do we go? Soc Neurosci. 2019 Oct;14(5):505-518. doi: 10.1080/17470919.2018.1497701. Epub 2018 Jul 21.
Deng J, Lei T, Du X. Effects of sensory integration training on balance function and executive function in children with autism spectrum disorder: evidence from Footscan and fNIRS. Front Psychol. 2023 Oct 25;14:1269462. doi: 10.3389/fpsyg.2023.1269462. eCollection 2023.
Chen H, Liang Q, Wang B, Liu H, Dong G, Li K. Sports game intervention aids executive function enhancement in children with autism - An fNIRS study. Neurosci Lett. 2024 Feb 6;822:137647. doi: 10.1016/j.neulet.2024.137647. Epub 2024 Jan 17.
Yeung MK. An optical window into brain function in children and adolescents: A systematic review of functional near-infrared spectroscopy studies. Neuroimage. 2021 Feb 15;227:117672. doi: 10.1016/j.neuroimage.2020.117672. Epub 2020 Dec 24.
Xu L, Hua Q, Yu J, Li J. Classification of autism spectrum disorder based on sample entropy of spontaneous functional near infra-red spectroscopy signal. Clin Neurophysiol. 2020 Jun;131(6):1365-1374. doi: 10.1016/j.clinph.2019.12.400. Epub 2020 Jan 13.
Eng CM, Pocsai M, Fulton VE, Moron SP, Thiessen ED, Fisher AV. Longitudinal investigation of executive function development employing task-based, teacher reports, and fNIRS multimethodology in 4- to 5-year-old children. Dev Sci. 2022 Nov;25(6):e13328. doi: 10.1111/desc.13328. Epub 2022 Oct 21.
Other Identifiers
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SETA
Identifier Type: -
Identifier Source: org_study_id
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