NCT07678294

Brief Summary

Executive functions, such as attention, inhibition, working memory, and planning, are important for early learning and school readiness in preschool children. This completed randomized controlled trial evaluated whether an 8-week cognitively enriched playful physical activity program could support executive functions and school readiness in preschool children compared with the regular physical education curriculum. Preschool children were assigned to either a playful physical activity intervention group or a control group receiving conventional physical education. The intervention included structured movement-based games designed to combine physical activity with cognitive challenges, including response inhibition, working memory, planning, rule following, and cooperative problem solving. Outcomes included measures of executive functions and school readiness domains, including mathematical, linguistic, and social competence.

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 Apr 2025

Shorter than P25 for not_applicable

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

April 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 25, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Playful physical activityCognitively enriched physical activityExecutive functionsSchool readinessPreschool childrenInhibitory controlWorking memoryPlanningCognitive-motor interventionEarly childhood education

Outcome Measures

Primary Outcomes (1)

  • Change in School Readiness Scores From Baseline to Post-intervention

    School readiness was assessed using mathematical competence, linguistic competence, and social competence scores. Higher scores indicated better school readiness.

    Baseline and immediately after the 8-week intervention

Secondary Outcomes (4)

  • Change in Go/No-Go Task Error Rate From Baseline to Post-intervention

    Baseline and immediately after the 8-week intervention

  • Change in Brief Visuospatial Memory Test-Revised Immediate Recall Score From Baseline to Post-intervention

    Baseline and immediately after the 8-week intervention

  • Change in Brief Visuospatial Memory Test-Revised Delayed Recall Score From Baseline to Post-intervention

    Baseline and immediately after the 8-week intervention

  • Change in Rey-Osterrieth Complex Figure Test Copy Score From Baseline to Post-intervention

    Baseline and immediately after the 8-week intervention

Study Arms (2)

Playful Physical Activities Intervention

EXPERIMENTAL

Preschool children assigned to this group received the 8-week Playful Physical Activities intervention.

Behavioral: Playful Physical Activities InterventionBehavioral: Regular Physical Education Curriculum

Regular Physical Education Curriculum

ACTIVE COMPARATOR

Preschool children assigned to this group received the regular physical education curriculum for 8 weeks.

Behavioral: Playful Physical Activities InterventionBehavioral: Regular Physical Education Curriculum

Interventions

The 8-week Playful Physical Activities intervention consisted of structured movement-based games integrating executive function challenges, including response inhibition, working memory, attention, planning, and cooperative problem-solving. Sessions were delivered three times per week for 60 minutes per session.

Also known as: PPA
Playful Physical Activities InterventionRegular Physical Education Curriculum

The control intervention consisted of the regular physical education curriculum delivered for 8 weeks, three times per week for 60 minutes per session. Sessions included traditional age-appropriate physical education activities without systematically embedded cognitive-motor executive function challenges.

Also known as: Conventional Physical Education
Playful Physical Activities InterventionRegular Physical Education Curriculum

Eligibility Criteria

Age55 Months - 64 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preschool children aged 55 to 64 months.
  • Enrollment in one of the participating preschools.
  • Ability to participate in age-appropriate physical activity sessions.
  • Written informed consent provided by parents or legal guardians.

You may not qualify if:

  • Motor or intellectual disabilities that could prevent participation in physical activity sessions.
  • Diagnosed neurological, psychiatric, or developmental disorders, including attention-deficit/hyperactivity disorder or autism spectrum disorder.
  • Uncorrected visual or auditory impairments that could affect test performance.
  • Use of medication known to affect the central nervous system.
  • Absence from post-intervention testing or failure to complete the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity, Sport and Health Research Unit UR18JS01, National Observatory of Sport

Tunis, 1003, Tunisia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation during baseline and post-intervention assessments. Participants, parents, teachers, and intervention providers were not blinded because of the nature of the physical activity intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This was a two-arm, parallel-group randomized controlled trial. Preschool children were assigned to either an experimental group receiving an 8-week cognitively enriched Playful Physical Activities intervention or a control group receiving the regular physical education curriculum.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

April 7, 2025

Primary Completion

May 23, 2025

Study Completion

May 23, 2025

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations