- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488286
Playful Physical Activity Program and Executive Function in Preschool Children
March 20, 2026 updated by: Monira Aldhahi
Effects of a Cognitively Enriched Playful Physical Activity Program on Executive Functions and School Readiness in Preschool Children: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This single-blind, parallel-group randomized controlled trial investigates the effects of a structured Playful Physical Activities (PPA) program on executive functions and school readiness in preschool children aged 5 years.
Participants are randomly assigned to an experimental group receiving cognitively enriched physical activity sessions or a control group receiving standard physical education with equivalent frequency and duration.
The intervention is conducted over 8 weeks (3 sessions/week, 60 minutes/session).
Outcomes include inhibitory control, visuospatial memory, planning, and school readiness domains (mathematical, linguistic, and social competence), assessed at baseline and post-intervention.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Manouba, Tunisia
- University of Manouba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Enrolled in preschool
- No physical/intellectual disability
- Parental consent
Exclusion Criteria:
- Neurological or developmental disorders
Sensory impairments
- medications affecting Neurological system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Playful Physical Activities (PPA) Program
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).
|
Receives cognitively enriched movement-based intervention
|
|
Other: Standard Physical Education
Regular preschool physical education consisting of free play and age-appropriate activities without structured cognitive engagement, matched for frequency and duration.
|
Receives usual physical education curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive function performance
Time Frame: Baseline (pre-intervention) and Week 8 (post-intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visuospatial memory (BVMT-R immediate recall)
Time Frame: Baseline and Week 8
|
Visuospatial memory will be assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R) immediate recall condition.
Performance is based on accuracy and spatial placement of reproduced figures.
|
Baseline and Week 8
|
|
Visuospatial memory (BVMT-R delayed recall)
Time Frame: Baseline and Week 8
|
Delayed visuospatial memory will be assessed using the BVMT-R delayed recall condition, measuring retention and reproduction of previously presented figures after a delay period.
|
Baseline and Week 8
|
|
Planning and visuospatial organization (RCFT copy score)
Time Frame: Baseline and Week 8
|
Planning ability and visuospatial organization will be assessed using the Rey-Osterrieth Complex Figure Test (RCFT).
Performance is quantified using standardized scoring based on accuracy and organization.
|
Baseline and Week 8
|
|
Linguistic competence
Time Frame: Baseline and Week 8
|
Linguistic competence will be assessed through tasks evaluating vocabulary, categorization, and verbal instruction-following abilities.
Higher scores indicate better language skills.
|
Baseline and Week 8
|
|
Social competence (QECS)
Time Frame: Baseline and Week 8
|
Social competence will be assessed using the Social and Emotional Competencies Evaluation Questionnaire (QACSE; Questionnaire d'Évaluation des Compétences Sociales et Émotionnelles), a 39-item instrument comprising five domains: self-control, social awareness, relationship skills, social isolation, and social anxiety.Each item is rated on a Likert scale, and total scores are calculated by summing item responses.
Scores range from [39 to 156] (depending on the response scale used).
Higher scores indicate better social and emotional competencies, except for negatively oriented subscales (e.g., social anxiety and social isolation), which are reverse-coded prior to total score calculation.
|
Baseline and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2025
Primary Completion (Actual)
January 10, 2026
Study Completion (Actual)
February 25, 2026
Study Registration Dates
First Submitted
March 17, 2026
First Submitted That Met QC Criteria
March 17, 2026
First Posted (Actual)
March 23, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PNU-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Executive Function
-
University School of Physical Education in WroclawActive, not recruitingCognitive Function | Executive FunctionPoland
-
Riphah International UniversityRecruitingExecutive FunctionPakistan
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of North Carolina, Chapel HillSigma XiCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedExecutive FunctionUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnited States Department of DefenseNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedExecutive FunctionUnited States
-
Rotman Research Institute at BaycrestUniversity of TorontoUnknown
-
University of Sao PauloSwiss Tropical & Public Health Institute; Grand Challenges Canada; Harvard University and other collaboratorsUnknown
-
New York Institute of TechnologyRecruitingExecutive Function (Cognition)United States
Clinical Trials on Playful Physical Activities
-
University of TartuRecruitingAutism Spectrum Disorder | Attention Deficit Hyperactivity DisorderEstonia
-
Universidad Autonoma de Baja CaliforniaNot yet recruiting
-
Instituto Mexicano del Seguro SocialEscuela Superior de Medicina, Instituto Politécnico Nacional; Doctorado en... and other collaboratorsNot yet recruitingPediatric Obesity | Childhood Obesity | Childhood OverweightMexico
-
Riphah International UniversityRecruitingAutism Spectrum DisorderPakistan
-
University Hospital, BordeauxCompletedCancer | Elderly PopulationFrance
-
Fatima Jinnah Women UniversityUnknownSchool Based InterventionPakistan
-
Westlake UniversityFirst People's Hospital of Hangzhou; Red Cross Hospital, Hangzhou, China; Hangzhou...WithdrawnCardiovascular Diseases | Diabetes Mellitus | Metabolic SyndromeChina
-
Comité Départemental Olympique et Sportif de Seine...Not yet recruiting
-
Tigers Running ClubCompletedBreast Cancer | Cancer SurvivorsSpain
-
University Rovira i VirgiliCompletedCardiovascular Diseases | Quality of Life