NCT07307742

Brief Summary

This study will test whether a structured motor-focused exercise program can improve both brain function and gross motor skills in preschool children. About 110 children aged 4 to 6 years will be recruited from kindergartens in Changsha, China. Classes will be randomly assigned to receive either (1) motor-focused physical education three times per week for 16 weeks, or (2) ordinary physical education of the same frequency and duration. The motor-focused program includes playful, game-based activities designed to strengthen locomotor skills (such as running and hopping) and object-control skills (such as throwing and catching). The main outcome will be changes in children's gross motor skills, measured with a standardized motor test (TGMD-3). Brain activity will also be assessed using portable electroencephalography (EEG) during rest and simple tasks related to attention and memory. Parents and teachers will complete short questionnaires about children's behavior and executive function. The results of this study may provide new insights into how physical education influences both movement skills and brain development in early childhood.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

December 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 13, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

Preschool childrenPhysical educationGross motor skillsMotor developmentNeurocognitive developmentEarly childhood education

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Competence (TGMD-3)

    Change in children's gross motor skills measured by the Test of Gross Motor Development-Third Edition (TGMD-3).

    Baseline (week 0) and immediately post-intervention (week 16).

Secondary Outcomes (6)

  • EEG Spectral Power

    Baseline (week 0) and post-intervention (week 16).

  • Event-Related Potentials (ERP)

    Baseline (week 0) and post-intervention (week 16).

  • Inhibitory Control

    Baseline (week 0) and post-intervention (week 16).

  • Working Memory

    Baseline (week 0) and post-intervention (week 16).

  • Executive Function (Parent Report)

    Baseline (week 0) and post-intervention (week 16).

  • +1 more secondary outcomes

Study Arms (2)

Motor-Focused Exercise Training

EXPERIMENTAL

Children will receive structured, motor-focused physical education sessions (30-40 minutes, 3 times per week, for 16 weeks), emphasizing locomotor and object-control skills through playful, game-based activities.

Behavioral: Motor-Focused Physical Education

Ordinary Physical Education

ACTIVE COMPARATOR

Children will continue with their regular kindergarten physical education curriculum (30-40 minutes, 3 times per week, for 16 weeks), focusing on rhythmic movement, free play, and group games.

Behavioral: Ordinary Physical Education

Interventions

Children will receive structured, motor-focused physical education sessions (30-40 minutes, 3 times per week, for 16 weeks), emphasizing locomotor and object-control skills through playful, game-based activities.

Motor-Focused Exercise Training

Children will continue with their regular kindergarten physical education curriculum (30-40 minutes, 3 times per week, for 16 weeks), focusing on rhythmic movement, free play, and group games.

Ordinary Physical Education

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4 to 6 years enrolled in participating kindergartens in Changsha, China
  • Physically healthy and able to safely participate in structured physical education activities
  • Written informed consent provided by a parent or legal guardian

You may not qualify if:

  • Diagnosed neurological, developmental, or musculoskeletal disorders that may interfere with motor performance or EEG measurement
  • Currently enrolled in specialized sports or motor-training programs outside of the kindergarten curriculum
  • Unable to comply with EEG assessment procedures due to behavioral or sensory intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Wang X, Zhou B. Motor development-focused exercise training enhances gross motor skills more effectively than ordinary physical activity in healthy preschool children: an updated meta-analysis. Front Public Health. 2024 May 21;12:1414152. doi: 10.3389/fpubh.2024.1414152. eCollection 2024.

  • Lyu W, Thung KH, Huynh KM, Wang L, Lin W, Ahmad S, Yap PT. Functional development of the human cerebellum from birth to age five. Nat Commun. 2025 Jul 10;16(1):6350. doi: 10.1038/s41467-025-61465-y.

  • Hao Y, Kong L, Wang X, Yu X. The impact of structured motor learning intervention on preschool children's executive functions. Sci Rep. 2025 May 25;15(1):18167. doi: 10.1038/s41598-025-01385-5.

  • Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

  • Chen J, Xiao Y, Xu B, Zhang D. The developmental trajectory of task-related frontal EEG theta/beta ratio in childhood. Dev Cogn Neurosci. 2023 Apr;60:101233. doi: 10.1016/j.dcn.2023.101233. Epub 2023 Mar 16.

  • Seitz HM, Cottrell BJ, Sturrock RF. A histological study of skin reactions of baboons to Schistosoma mansoni schistosomula. Trans R Soc Trop Med Hyg. 1987;81(3):385-90. doi: 10.1016/0035-9203(87)90144-1.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be masked to group allocation. Individuals conducting motor skill testing and EEG recordings will not be informed of whether children are in the intervention or control group. Video recordings of motor performance will be independently scored by two raters who are blinded to both group assignment and assessment time point. Data analysts will also remain blinded until the primary analyses are completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 29, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share