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La Pause, Apprenez et Activez-Vous (PLAY) (PLAY)

29 octobre 2026 mis à jour par: Matteo Vandoni, University of Pavia

Pauses Actives à l'École : L'Essai Contrôlé Randomisé en Grappes Pause, Apprends et Active-Toi (PLAY)

Many children spend a large part of the school day sitting, which can limit their opportunities to be physically active. Regular physical activity is important for children's physical health, mental well-being, and positive attitudes toward movement. Schools represent an ideal setting to promote healthy behaviors, as they reach nearly all children on a daily basis.

This study aims to evaluate the effects of short, classroom-based Active Breaks on children attending primary school. Active Breaks are brief periods of physical activity integrated into regular classroom lessons. These activities are designed to be fun, safe, and easy to perform in the classroom, without reducing academic teaching time.

The main goal of the study is to assess whether participating in Active Breaks improves children's enjoyment of physical activity. Enjoyment is an important factor because children who find physical activity enjoyable are more likely to stay active over time. The study also examines whether Active Breaks influence physical activity levels, basic motor skills, physical fitness perception and ponderal status.

The intervention lasts 12 weeks and is carried out during the normal school timetable. In the intervention group, children perform one Active Break during each school hour. Each break lasts approximately 5 minutes and includes playful aerobic and strength-based movements that require little or no equipment. The activities are guided by classroom teachers, who receive specific training and materials before the start of the study. A comparison group continues with the usual classroom routine.

Participation in the study is voluntary. Parents or legal guardians provide written informed consent, and children provide verbal assent. All activities are appropriate for primary school children and are conducted in a safe and supervised environment. Children may withdraw from the study at any time without any consequences.

The results of this study may help schools and policymakers understand whether simple, low-cost strategies such as Active Breaks can promote healthier and more active school days for children.

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

857

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Pavia
      • Pavia, Pavia, Italie, 27100
        • Laboratory of Adapted Motor Activity

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 12 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Regular participation in school activities and physical education classes.
  • Ability to understand and follow the instructions related to the study protocol.
  • Enrollment in the study through verbal assent from the child and written informed consent from a parent or legal guardian.

Exclusion Criteria:

  • Any medical contraindication to participation in physical activity.
  • Musculoskeletal injuries occurring within the three months prior to baseline assessment.
  • Physical or cognitive limitations that prevent participation in the planned activities.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Routine habituelle
Expérimental: Pauses Actives Guidées par Vidéo

The intervention consists of classroom-based Active Breaks (ABs), delivered through pre-recorded instructional videos integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time.

The intervention lasts 12 weeks and is delivered once every school hour. Each Active Break lasts approximately 5 minutes and is preceded by a brief introductory segment within the video. Activities are conducted during the regular school timetable in primary school classrooms.

Video-guided ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers facilitate transitions but do not actively lead the exercises.

Expérimental: Pauses actives dirigées par l'enseignant

The intervention consists of classroom-based, teacher-led Active Breaks (ABs) integrated into regular school lessons. ABs are short bouts of physical activity aimed at reducing sedentary time and promoting moderate-to-vigorous physical activity without reducing instructional time.

The intervention lasts 12 weeks and is delivered once every school hour. Each AB lasts approximately 5 minutes. All activities take place during the regular school timetable in primary school classrooms.

ABs include standardized, playful aerobic and muscle-strengthening exercises requiring little or no equipment and adaptable to classroom spaces. Activities are cognitively engaging and emphasize enjoyment, participation, and inclusiveness rather than performance. Classroom teachers deliver the ABs live after receiving standardized training and instructional materials to ensure consistent implementation with the video-guided group.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Perceived enjoyment of physical activity
Délai: From enrollment to the end of treatment at 12 weeks

Perceived enjoyment of physical activity will be assessed using the Physical Activity Enjoyment Scale (PACES) questionnaire. The outcome is the change in mean PACES score (unit: questionnaire score) from baseline (Week 0) to post-intervention (Week 12).

From enrollment to the end of treatment at 12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Motor competence
Délai: From enrollment to the end of treatment at 12 weeks

Motor competence will be assessed using the Motorische Basiskompetenzen (MOBAK) test battery. The outcome is the change in total MOBAK score (unit: points) from baseline to post-intervention. The MOBAK assesses basic motor competencies across object control and self-movement domains, with a total possible score of 0-16 points, using age-appropriate versions.

From enrollment to the end of treatment at 12 weeks
Objectively measured physical activity
Délai: From enrollment to the final week of treatment at 11 weeks

Physical activity will be objectively assessed using FIBION wearable sensors. The outcome is the change in time spent in moderate-to-vigorous physical activity (MVPA) (unit: minutes per day) from baseline to post-intervention, derived from accelerometry-based sensor data.

From enrollment to the final week of treatment at 11 weeks
Perceived motor competence
Délai: From enrollment to the end of treatment at 12 weeks

Perceived motor competence will be assessed using the SEMOK questionnaire. The outcome is the change in SEMOK score (unit: questionnaire score) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Objectively measured sleep continuity
Délai: From enrollment to the end of treatment at 12 weeks

Sleep will be objectively assessed from accelerometer data processed using the GGIR package. Sleep continuity will be operationalized as wake after sleep onset (WASO) (unit: minutes per night), and the outcome will be the change in WASO from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Lower-limb explosive strength
Délai: From enrollment to the end of treatment at 12 weeks

Lower-limb explosive strength will be assessed using the standing broad jump. The outcome is the change in the distance jumped (unit: centimeters, cm) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Upper limb explosive strength
Délai: From enrollment to the end of treatment at 12 weeks

Upper limb explosive strength will be assessed using the medicine ball throw. The outcome is the change in the thrown distance (unit: centimeters, cm) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Upper limb strength
Délai: From enrollment to the end of treatment at 12 weeks

Upper limb strength will be assessed using the handgrip strength test. The test will be performed two times per each hand and the outcome is the change of the best results of both hands (unit: kilograms, kg) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Speed-agility
Délai: From enrollment to the end of treatment at 12 weeks

Speed-agility will be assessed using the 4×10 m shuttle run. The outcome is the change in the test performance (unit: seconds, s) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Anthropometric characteristics
Délai: From enrollment to the end of treatment at 12 weeks

Anthropometric characteristics will be assessed following the International Society for the Advancement of Kinanthropometry (ISAK) guidelines. Outcomes include changes in body weight (kg), height (cm), sitting height (cm), waist and hip circumferences (cm), and BMI z-score from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Body weight
Délai: From enrollment to the end of treatment at 12 weeks

Body weight will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a calibrated digital scale. The outcome is the change in body weight (unit: kilograms) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Standing height
Délai: From enrollment to the end of treatment at 12 weeks

Standing height will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a stadiometer. The outcome is the change in standing height (unit: centimeters) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Waist girth
Délai: From enrollment to the end of treatment at 12 weeks

Waist girth will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a non-elastic measuring tape at the standardized anatomical landmark. The outcome is the change in waist circumference (unit: centimeters) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Hip girth
Délai: From enrollment to the end of treatment at 12 weeks

Hip girth will be assessed according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines using a non-elastic measuring tape at the standardized anatomical landmark. The outcome is the change in hip circumference (unit: centimeters) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Body mass index z-score (BMI z-score)
Délai: From enrollment to the end of treatment at 12 weeks

BMI z-scores will be derived using age- and sex-specific reference values. The outcome is the change in BMI z-score (unit: z-score) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks
Waist-to-hip ratio
Délai: From enrollment to the end of treatment at 12 weeks

Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. The outcome is the change in waist-to-hip ratio (unit: ratio) from baseline to post-intervention.

From enrollment to the end of treatment at 12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Matteo Vandoni, University of Pavia

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 février 2026

Achèvement primaire (Réel)

30 juin 2026

Achèvement de l'étude (Réel)

30 juin 2026

Dates d'inscription aux études

Première soumission

19 janvier 2026

Première soumission répondant aux critères de contrôle qualité

16 février 2026

Première publication (Réel)

19 février 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • PLAY-IC-2025

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the published results, together with the corresponding data dictionary, will be made available to qualified researchers upon reasonable request to the Principal Investigator, Prof. Matteo Vandoni, University of Pavia, following publication of the primary trial findings. Data sharing will be subject to scientific review, applicable ethical and data protection requirements, and a data use agreement where appropriate.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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