NCT07532395 FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
| NCT ID | NCT07532395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-11-22 |
| Primary Completion | 2026-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2025-11-22 with a primary completion date of 2026-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. This randomized controlled trial will evaluate a 12-week Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 children with ASD aged 3-6 years, compared with a Treatment As Usual (TAU) control group. The program integrates progressive FMS training with CrossFit-style circuit training to improve motor competence, social interaction, and self-regulation. Primary outcomes focus on school readiness assessed by the Strengths and Difficulties Questionnaire (SDQ), while secondary outcomes include motor development, executive function, social responsiveness, and biomarkers. Assessments will be conducted at baseline, mid-intervention (8 weeks), post-intervention (12 weeks), and follow-up (20 weeks).
Eligibility Criteria
Inclusion Criteria: 1. age 3-6 years; 2. confirmed ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2); 3. written informed consent from parent/caregiver. Exclusion Criteria: 1. participation in structured exercise programs within the preceding 6 months; 2. comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder); 3. visual, auditory or intellectual impairments that would interfere with participation; 4. history of significant head trauma or brain injury; 5. medical contraindications to physical activity ; 6. other factors deemed unsuitable for program participation by the research team.
Contact & Investigator
Yuelong Ji, PHD
PRINCIPAL INVESTIGATOR
Peking University
Frequently Asked Questions
Who can join the NCT07532395 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532395 currently recruiting?
Yes, NCT07532395 is actively recruiting participants. Contact the research team at yuelong.ji@pku.edu.cn for enrollment information.
Where is the NCT07532395 trial being conducted?
This trial is being conducted at Beijing, China, Fuzhou, China.
Who is sponsoring the NCT07532395 clinical trial?
NCT07532395 is sponsored by Peking University. The principal investigator is Yuelong Ji, PHD at Peking University. The trial plans to enroll 184 participants.