- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07678294
Playful Physical Activity for Executive Functions and School Readiness in Preschool Children (PPA-EF-SR)
Effects of a Cognitively Enriched Playful Physical Activity Program on Executive Functions and School Readiness in Preschool Children
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.
Přehled studie
Postavení
Detailní popis
This study was designed as a completed, two-arm randomized controlled trial conducted in preschool children. The purpose of the study was to examine whether a cognitively enriched playful physical activity program could improve executive functions and school readiness compared with the regular physical education curriculum.
The experimental intervention consisted of an 8-week Playful Physical Activities program. The program included structured movement games designed to engage both motor and cognitive processes. Activities targeted gross and fine motor skills while incorporating executive-function demands such as selective attention, inhibitory control, working memory, planning, rule maintenance, and cooperative problem solving. Sessions included playful tasks related to language, mathematics, and social interaction, with the aim of supporting both cognitive development and school readiness in an age-appropriate educational setting.
Children in the control group continued to receive the conventional physical education curriculum over the same intervention period. The control condition involved regular age-appropriate physical education activities without the systematic integration of structured executive-function challenges or cognitive-motor dual-task components.
Participants were preschool children aged approximately 55 to 64 months. Eligible children were enrolled in participating preschool settings and were able to take part in physical activity sessions. Children with motor or mental disorders that could interfere with participation or outcome assessment were excluded.
The primary focus of the study was school readiness, including mathematical, linguistic, and social competence. Secondary outcomes included executive-function measures related to attention, inhibition, visuospatial memory, and planning/visuospatial organization. Assessments were conducted before and after the intervention period.
The study was conducted in accordance with ethical approval from the Local Research Ethics Committee at the High Institute of Sports and Physical Education of Ksar Said. The study has been completed.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Tunis, Tunisko, 1003
- Physical Activity, Sport and Health Research Unit UR18JS01, National Observatory of Sport
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Playful Physical Activities Intervention
Preschool children assigned to this group received the 8-week Playful Physical Activities intervention.
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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.
Ostatní jména:
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.
Ostatní jména:
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Aktivní komparátor: Regular Physical Education Curriculum
Preschool children assigned to this group received the regular physical education curriculum for 8 weeks.
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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.
Ostatní jména:
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in School Readiness Scores From Baseline to Post-intervention
Časové okno: Baseline and immediately after the 8-week intervention
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School readiness was assessed using mathematical competence, linguistic competence, and social competence scores.
Higher scores indicated better school readiness.
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Baseline and immediately after the 8-week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Go/No-Go Task Error Rate From Baseline to Post-intervention
Časové okno: Baseline and immediately after the 8-week intervention
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Inhibitory control was assessed using the Go/No-Go task.
The outcome was the number of commission errors, with lower scores indicating better inhibitory control.
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Baseline and immediately after the 8-week intervention
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Change in Brief Visuospatial Memory Test-Revised Immediate Recall Score From Baseline to Post-intervention
Časové okno: Baseline and immediately after the 8-week intervention
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Visuospatial memory was assessed using the BVMT-R immediate recall raw score.
Higher scores indicated better visuospatial memory performance.
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Baseline and immediately after the 8-week intervention
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Change in Brief Visuospatial Memory Test-Revised Delayed Recall Score From Baseline to Post-intervention
Časové okno: Baseline and immediately after the 8-week intervention
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Delayed visuospatial recall was assessed using the BVMT-R delayed recall raw score.
Higher scores indicated better delayed recall performance.
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Baseline and immediately after the 8-week intervention
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Change in Rey-Osterrieth Complex Figure Test Copy Score From Baseline to Post-intervention
Časové okno: Baseline and immediately after the 8-week intervention
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Visuospatial organization and planning were assessed using the Rey-Osterrieth Complex Figure Test copy score.
Higher scores indicated better visuospatial planning and organization.
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Baseline and immediately after the 8-week intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- PPA-EF-SR-2025
- 41034 (Identifikátor registru: Pan African Clinical Trials Registry (PACTR); official trial number pending)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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Klinické studie na Playful Physical Activities Intervention
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