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暂停、学习并激活自己(PLAY) (PLAY)

2026年10月29日 更新者:Matteo Vandoni、University of Pavia

学校主动休息:《暂停、学习与激活自我(PLAY)》整群随机对照试验

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.

研究概览

研究类型

介入性

注册 (实际的)

857

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pavia
      • Pavia、Pavia、意大利、27100
        • Laboratory of Adapted Motor Activity

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5年 至 12年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:常规流程
实验性的:视频引导式主动休息

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.

实验性的:教师主导的课间活动

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Perceived enjoyment of physical activity
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Motor competence
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Matteo Vandoni、University of Pavia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月16日

初级完成 (实际的)

2026年6月30日

研究完成 (实际的)

2026年6月30日

研究注册日期

首次提交

2026年1月19日

首先提交符合 QC 标准的

2026年2月16日

首次发布 (实际的)

2026年2月19日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • PLAY-IC-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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