Clinical Trial

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

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-29.
Trial Details
NCT Number NCT07104708
Lead Sponsor Chen Li
Collaborators: Gansu Provincial Maternal and Child Health Care Hospital
Conditions Autism Spectrum Disorder
Enrollment 70 participants
Start Date 2025-08
Primary Completion 2027-07 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-14