NCT07488286

Brief Summary

This randomized controlled trial evaluates the effects of an 8-week cognitively enriched playful physical activity program on executive functions and school readiness in preschool children. Participants are assigned to either an experimental group receiving structured cognitively engaging movement activities or a control group receiving standard physical education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 17, 2026

Last Update Submit

March 20, 2026

Conditions

Keywords

Cognitive DevelopmentPreschool education

Outcome Measures

Primary Outcomes (1)

  • Executive function performance

    Executive function performance will be assessed using standardized neuropsychological measures, including inhibitory control (Go/No-Go task; error rate), Performance is quantified as the number of commission errors (responses to No-Go stimuli). Lower error rates indicate better inhibitory control.

    Baseline (pre-intervention) and Week 8 (post-intervention)

Secondary Outcomes (5)

  • Visuospatial memory (BVMT-R immediate recall)

    Baseline and Week 8

  • Visuospatial memory (BVMT-R delayed recall)

    Baseline and Week 8

  • Planning and visuospatial organization (RCFT copy score)

    Baseline and Week 8

  • Linguistic competence

    Baseline and Week 8

  • Social competence (QECS)

    Baseline and Week 8

Study Arms (2)

Playful Physical Activities (PPA) Program

EXPERIMENTAL

A structured program integrating cognitive challenges (inhibition, working memory, planning) into movement-based activities delivered 3 times per week for 8 weeks (60 minutes/session).

Behavioral: Playful Physical Activities

Standard Physical Education

OTHER

Regular preschool physical education consisting of free play and age-appropriate activities without structured cognitive engagement, matched for frequency and duration.

Behavioral: Standard Physical Education Group

Interventions

Receives cognitively enriched movement-based intervention

Playful Physical Activities (PPA) Program

Receives usual physical education curriculum

Standard Physical Education

Eligibility Criteria

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

You may qualify if:

  • Enrolled in preschool
  • No physical/intellectual disability
  • Parental consent

You may not qualify if:

  • Neurological or developmental disorders
  • Sensory impairments
  • medications affecting Neurological system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manouba

Manouba, Tunisia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded to group allocation; participants and instructors are not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either a cognitively enriched physical activity program or standard physical education.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

January 10, 2025

Primary Completion

January 10, 2026

Study Completion

February 25, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations