Effects of Systematic Exercise Training on Core Symptoms, Executive Function and Brain Function in Children With ASD

NCT07104708 | Not Yet Recruiting

• 1 other identifier: SETA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that children with ASD simultaneously have deficits in overall executive function and impairments in basic motor skills, which have a negative impact on cognitive and social all-round development. In recent years, intervention measures for the motor skills of children with ASD have gradually developed. However, based on the existing literature, there is still a lack of recommendations for sports training at present. The sustained effect of exercise intervention training on the core symptoms of ASD remains unclear. In terms of executive function, there are relatively few studies on the executive function of preschool children. The impact of motor training on working memory in school-aged children is still inconsistent. Furthermore, the connection characteristics of different brain regions in children with ASD after physical training remain unclear. This study will include 70 children with ASD aged 3 to 9 years for a multicenter randomized controlled trial (RCT). These children will be randomly assigned to the intervention group (Child-Parent-Trainer program) and the control group (regular physical education program) for 12 weeks, 5 days/week, 60 minutes/day training. Children's core symptoms, executive function, child/family quality of life, and functional near-infrared spectroscopy (fNIRS) were assessed at baseline (training weeks 0) and endpoints (training weeks 13 and 17), respectively. To verify the improvement effect of this exercise program on the autism severity, core symptoms and executive functions of children with ASD, as well as its impact on family quality of life. Furthermore, through fNIRS for monitoring changes in brain function, the potential neural physiological mechanisms will be explored.

Conditions

Autism Spectrum Disorder

Keywords

executive function; brain function; exercise training; Autism spectrum disorder

Outcome Measures

Primary Outcomes (4)

• The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2

  The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2 Description: The Autism Diagnostic Observation Schedule-2 (ADOS-2) is adopted to assess the changes in the degree of ASD disorder. The Autism Diagnostic Observation Schedule-2 (ADOS-2) is a standardized observational assessment. The assessment includes abilities in four areas: social interaction, stereotypical behavior, verbal communication, emotion, and abnormal behavior. Children in the our study were administered a module 1 for children with little or no phrase speech or Module 2, for children who use phrase speech but are not yet fluent. Standardized ADOS scores in the domains of social affect (SA) and restricted repetitive behaviors (RRB) were calculated as indicators of ASD severity.

  Training weeks 0, 13, and 17.

• The changes in degree of ASD disorder by Childhood Autism Rating Scale (CARS)

  The Childhood Autism Rating Scale (CARS) are adopted to assess the changes in the degree of ASD disorder. The Childhood Autism Rating Scale (CARS) serves as an assessment indicator for the improvement of ASD symptoms. The scale consists of 15 items including relationship with people, imitation, emotional response, etc. The evaluation criteria for therapeutic effect are as follows: a CARS score reduction of less than or equal to 10 is considered effective, a CARS score reduction of 5 to 9 is considered effective, and a score reduction of less than 5 is considered ineffective.

  Training weeks 0, 13, and 17.

• The changes of executive functions

  The preschool BRIEF is consisted of 63 entries and divided into 5 factors and 3 dimensions. The 5 factors are inhibition, conversion, affective control, working memory, and organizational planning. The 3 dimensions are the inhibitory self-regulation index (including inhibition and affective control), cognitive flexibility index (including conversion and affective control) and metacognitive index (including working memory and organizational planning). School-age children BRIEF, consisting of 86 entries, is divided into 2 dimensions: behavior management index (including 3 factors of inhibition, conversion and emotional control) and metacognitive function index (including 5 factors of task initiation, working memory, planning, organization and monitoring). The higher the score, the more impaired the executive function. We examine the score of BRIEF to reflect changes in executive function before and after training.

  Training weeks 0, 13, and 17.

• The changes of brain function detection indicators

  We monitor cerebral hemodynamic changes through the fNIRS device. The Go/No-Go paradigm task was performed on children over 4 years old. This paradigm consists of two main parts, GO and GO /No-Go. During the GO task, participants are shown pictures of two animals (a giraffe and a lion) and instructed to quickly press the space bar when they see an animal picture. During the GO /No-Go task, pictures of two animals (a tiger and an elephant) are shown at random, and children are asked to quickly press the space bar when they see an elephant. To record correct rate and response time for analysis. All the subjects will undergo resting-state functional connectivity tests. We will compare the differences in fNIRS features before and after training.

  Training weeks 0, 13, and 17.

Secondary Outcomes (4)

• The changes of children's life quality by Child Eating Behavior Questionnaire (CEBQ)

  Training weeks 0, 13, and 17.

• The changes of children's life quality by Children's Sleep Habits Questionnaire (CSHQ)

  Training weeks 0, 13, and 17.

• The changes of parents' life quality by Parenting Stress Index (PSI)

  Training weeks 0, 13, and 17.

• The changes in heart rate

  At exercise training.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program) for 12 weeks (5 days/week, 60 minutes/day).

Procedure: The Child-Parent- Trainer exercise program

Control group

ACTIVE COMPARATOR

The control group received regular physical training courses for 12 weeks (5 days/week, 60 minutes/day).

Procedure: The regular physical training

Interventions

The Child-Parent- Trainer exercise program PROCEDURE

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.

Intervention group

The regular physical training PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 3-9 years old.
• 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.

You may not qualify if:

• Vision/ hearing disorders, schizophrenia, emotional disorders, mental retardation, Rett syndrome and other developmental disorders.
• 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.
• Unable to cooperate with persistent completion of intervention.

Sponsors & Collaborators

• Chen Li: lead
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

• yu T Li, Doctor

  Children's Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Chen, doctor

CONTACT

136 7762 0103; chenli2012@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director

Model Details: The children are randomly divided into a intervention group and a control group. On the basis of the basic ASD rehabilitation training, the children will be trained for 12 weeks (5 days/week, 60 minutes/day). The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program), while the control group received regular physical training courses.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)