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일시 정지, 학습, 그리고 스스로 활성화하기 (PLAY) (PLAY)

2026년 10월 29일 업데이트: Matteo Vandoni, University of Pavia

학교에서의 활동적 휴식: 일시 정지, 학습, 그리고 스스로 활성화하기(PLAY) 클러스터 무작위 대조 시험

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.

연구 개요

연구 유형

중재적

등록 (실제)

857

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

5년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 일상적인 루틴
실험적: 비디오 안내 활동적 휴식

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.

실험적: 교사 주도 활동 휴식

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Perceived enjoyment of physical activity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Motor competence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Matteo Vandoni, University of Pavia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 16일

기본 완료 (실제)

2026년 6월 30일

연구 완료 (실제)

2026년 6월 30일

연구 등록 날짜

최초 제출

2026년 1월 19일

QC 기준을 충족하는 최초 제출

2026년 2월 16일

처음 게시됨 (실제)

2026년 2월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 29일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • PLAY-IC-2025

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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