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La Pausa, Aprende y Actívate a Ti Mismo (PLAY) (PLAY)

29 de octubre de 2026 actualizado por: Matteo Vandoni, University of Pavia

Descansos Activos en la Escuela: El Ensayo Controlado Aleatorizado por Grupos Pausa, Aprende y Actívate (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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

857

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 12 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Rutina habitual
Experimental: Pausas Activas Guiadas por Vídeo

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.

Experimental: Descansos Activos Dirigidos por el Profesor

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceived enjoyment of physical activity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor competence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Matteo Vandoni, University of Pavia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de febrero de 2026

Finalización primaria (Actual)

30 de junio de 2026

Finalización del estudio (Actual)

30 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de febrero de 2026

Publicado por primera vez (Actual)

19 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PLAY-IC-2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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