Executive FunctionNCT07488286
Playful Physical Activity Program and Executive Function in Preschool Children
A study testing Playful Physical Activities and Standard Physical Education Group in people with Executive Function and School Readiness, run by Monira Aldhahi at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function, School Readiness
- What is being tested?
- Playful Physical Activities and Standard Physical Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Jan 2025to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Enrolled in preschool
- No physical/intellectual disability
- Parental consent
Who cannot join
- Neurological or developmental disorders
- Sensory impairments
- medications affecting Neurological system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Executive Function, School Readiness
- Being tested
- Playful Physical Activities, Standard Physical Education Group
- Keywords
- Cognitive Development, Preschool education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playful Physical ActivitiesBehavioural
Receives cognitively enriched movement-based intervention
Standard Physical Education GroupBehavioural
Receives usual physical education curriculum
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Standard Physical Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and Week 8 (post-intervention)
Secondary outcomes (5)
Visuospatial memory (BVMT-R immediate recall)
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.
Measured: Baseline and Week 8
Visuospatial memory (BVMT-R delayed recall)
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.
Measured: Baseline and Week 8
Planning and visuospatial organization (RCFT copy score)
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.
Measured: Baseline and Week 8
Linguistic competence
Linguistic competence will be assessed through tasks evaluating vocabulary, categorization, and verbal instruction-following abilities. Higher scores indicate better language skills.
Measured: Baseline and Week 8
Social competence (QECS)
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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start10 Jan 2025
- Primary completion10 Jan 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either a cognitively enriched physical activity program or standard physical education.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monira Aldhahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monira Aldhahi, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488286
- Sponsor's protocol ID
- PNU-13
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitively Enriched Playful Physical Activity Program on Executive Functions and School Readiness in Preschool Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07488286
- Acronym / sponsor ID
- PNU-13
- Conditions
- Executive Function, School Readiness
- Keywords
- Cognitive Development, Preschool education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Monira AldhahiUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either a cognitively enriched physical activity program or standard physical education.
| Arm | Type | Receives |
|---|---|---|
| Playful Physical Activities (PPA) Program | Experimental | Behavioral: Playful Physical ActivitiesA structured program integrating cognitive challenges (inhibition, working memory, planning) into movement-based activities delivered 3 times per week for 8 weeks (60 minutes/session). |
| Standard Physical Education | Other | Behavioral: Standard Physical Education GroupRegular preschool physical education consisting of free play and age-appropriate activities without structured cognitive engagement, matched for frequency and duration. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Enrolled in preschool
- No physical/intellectual disability
- Parental consent
Key exclusion criteria (3 listed)
- Neurological or developmental disorders
- Sensory impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playful Physical ActivitiesReceives cognitively enriched movement-based intervention | Behavioural | Playful Physical Activities (PPA) Program |
| Standard Physical Education GroupReceives usual physical education curriculum | Behavioural | Standard Physical Education |
Primary outcome
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.
5 secondary outcomes
Visuospatial memory (BVMT-R immediate recall)
Time frame: Baseline and Week 8
Visuospatial memory (BVMT-R delayed recall)
Time frame: Baseline and Week 8
Planning and visuospatial organization (RCFT copy score)
Time frame: Baseline and Week 8
Linguistic competence
Time frame: Baseline and Week 8
Social competence (QECS)
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playful Physical Activities and Standard Physical Education Group in people with Executive Function and School Readiness, run by Monira Aldhahi at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function performance (time frame: Baseline (pre-intervention) and Week 8 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.