このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Immersive Physical Activity Program for Overweight Schoolchildren (PEESO)

2026年6月26日 更新者:José M. Cancela、University of Vigo

Immersive Recreational Physical Exercise Program for Schoolchildren With Overweight or Obesity (PEESO)

Childhood overweight and obesity are major public health concerns associated with increased cardiometabolic risk and reduced quality of life. In Galicia (Spain), approximately one-third of schoolchildren aged 7-15 years are affected. Physical inactivity and sedentary behaviors contribute significantly to this condition.

The PEESO Project is a clinical trial designed to evaluate the effects of an immersive virtual reality-based physical exercise program delivered during school recess in children with overweight or obesity. The intervention uses head-mounted displays to promote moderate-to-vigorous intensity physical activity in an engaging environment.

調査の概要

詳細な説明

Childhood overweight and obesity are major public health concerns worldwide and are associated with increased risk of cardiometabolic disease, musculoskeletal disorders, and reduced quality of life. In Galicia (Spain), approximately one-third of schoolchildren aged 7-15 years present overweight or obesity. Physical inactivity and excessive sedentary behaviors, particularly screen time, contribute significantly to this condition.

The PEESO Project is a clinical trial designed to evaluate the effects of an immersive recreational physical exercise program delivered during school recess in children diagnosed with overweight or obesity. The intervention uses immersive virtual reality (IVR) technology through head-mounted displays to create an interactive and engaging environment that promotes moderate-to-vigorous intensity physical activity.

Immersive virtual reality may enhance exercise adherence and enjoyment by increasing motivation and reducing perceived exertion through distraction. Although active video games (exergames) have demonstrated potential to increase daily physical activity and reduce body mass index (BMI), most previous studies have focused on non-immersive systems and adult populations.

The primary objective of this study is to determine the effect of a moderate-to-vigorous intensity immersive virtual exercise program on body composition in schoolchildren with overweight or obesity. Secondary objectives include assessing its impact on quality of life and other health-related outcomes. The intervention is implemented during academic recess periods to ensure feasibility and integration within the school setting.

研究の種類

介入

入学 (推定)

36

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Pontevedra
      • Vigo、Pontevedra、スペイン、36210
        • Ies Santa Irene

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion criteria:

  • Age: >12 to 16 years (n>15).
  • BMI: >25.5 kg/m² (overweight) and >30 kg/m² (obesity classes I-IV).
  • Agreement to participate in the study.
  • Signed informed consent from parents or guardians.

Exclusion criteria:

  • Presence of cardiovascular, pulmonary, or musculoskeletal conditions that would prevent participation in the virtual session.
  • Inability to comply with the assessment protocol.
  • Presence of severe visual or hearing impairment, vertigo, epilepsy, or uncontrolled psychosis.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:RVI_Experimental_Immersive Virtual Reality Exergame Program
The PEESO intervention is an immersive recreational physical exercise program designed for schoolchildren with overweight or obesity. The intervention is delivered during school recess periods using Head-Mounted Display (HMD)-based immersive virtual reality exergames. The program aims to provide moderate-to-vigorous intensity physical activity through personalized exercise sessions in a motivating and interactive environment.
Participants assigned to the experimental group will perform immersive virtual reality exercise sessions THREE (3) TIMES A WEEK during school breaks. The intervention lasts 24 weeks, following a one-week adaptation period to the head-mounted devices (HMDs) and exercise video games. Exercise routines will be personalized to each participant's characteristics using a "Weight Loss" mode and will include three training categories: Full Body (6 weeks), Strength (9 weeks), and Boxing (9 weeks). The exercise load will be programmed individually through the exercise video game platform based on each participant's progress and performance. The sessions are designed to achieve a moderate to vigorous level of physical activity.
プラセボコンパレーター:RVI_ControGroup_Immersive Virtual Reality Exergame Program
The PEESO intervention in the control group will be the same as in the experimental group: a recreational and immersive physical exercise program designed for overweight or obese schoolchildren. It is conducted during school recess using immersive virtual reality exercise video games with virtual reality headsets (HMDs). The program aims to provide moderate-to-vigorous physical activity through personalized exercise sessions in a motivating and interactive environment.
Participants assigned to the control group will perform immersive virtual reality exercise sessions ONE TIMES (1) A WEEK during school breaks. The intervention lasts 24 weeks, following a one-week adaptation period to the head-mounted devices (HMDs) and exercise video games. Exercise routines will be personalized to each participant's characteristics using a "Weight Loss" mode and will include three training categories: Full Body ( 6 weeks), Strength (9 weeks), and Boxing (9 weeks). The exercise load will be programmed individually through the exercise video game platform based on each participant's progress and performance. The sessions are designed to achieve a moderate to vigorous level of physical activity.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Assessment body composition
時間枠:24 weeks

Description: Body composition was assessed using the Tanita MC-780 bioelectrical impedance analyzer. Measured variables included fat mass (FM), fat-free mass (FFM), muscle mass (MM), total body water (TBW), and segmental body composition of the trunk and limbs.

Unit of Measurement:

Fat Mass (FM): kg

Fat-Free Mass (FFM): kg

Muscle Mass (MM): kg

Total Body Water (TBW): kg

Segmental Body Composition: kg

Interpretation: Higher FFM, MM, and TBW indicate better physical fitness. Lower FM indicates better body composition.

24 weeks
Assessment user experience and engagement
時間枠:24 weeks

User experience and engagement will be assessed using the Game Experience Questionnaire (GEQ - Post-Game Module). Items are rated from 0 to

Unit of Measure:

GEQ subscale scores (0-4)

Interpretation:

Higher scores indicate better experience for positive dimensions and poorer experience for negative dimensions.

24 weeks
Assessment Safety and cybersickness symptoms
時間枠:24 weeks

Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms.

Unit of Measure:

SSQ total score

Interpretation:

Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms.

Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms.

Unit of Measure:

SSQ total score

Interpretation:

Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms.

24 weeks
Assessment usability
時間枠:24 weeks

System usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Scores range from 0 to 100, with higher scores indicating better usability.

Unit of Measure:

SUS score (0-100)

Interpretation:

Scores ≥68 indicate acceptable usability; scores >80 indicate excellent usability.

24 weeks
Health-Related Quality of Life (KINDL)
時間枠:24 weeks

Description:

Health-related quality of life will be assessed using the KINDL Questionnaire, a validated instrument that evaluates children's and adolescents' well-being across multiple domains, including physical well-being, emotional well-being, self-esteem, social relationships, and school functioning. Scores are calculated according to the instrument scoring manual and transformed to a scale from 0 to 100.

Unit of Measure:

KINDL total score (0-100) Emotional well-being (0-100) Physical well-being (0-100) Self-esteem (0-100) Social relationships (0-100) School functioning (0-100)

Interpretation:

Higher scores indicate better health-related quality of life and well-being in the corresponding domain. Lower scores indicate poorer perceived quality of life and greater difficulties in physical, emotional, social, or school-related functioning.

24 weeks
Physical Activity Level
時間枠:24 weeks

Description:

Physical activity and sedentary behavior will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), child/adapted version. The questionnaire evaluates moderate-to-vigorous physical activity (MVPA), sedentary time, and total physical activity.

Unit of Measure:

Moderate-to-vigorous physical activity (MVPA): minutes/week Sedentary time: minutes/day or hours/day Total physical activity: MET-minutes/week

Interpretation:

Higher MVPA and total physical activity scores indicate greater participation in physical activity and better activity levels. Higher sedentary time indicates more time spent inactive and poorer movement behavior. Lower sedentary time and higher physical activity levels reflect a healthier lifestyle.

24 weeks
Assessment Muscular Strength
時間枠:24 weeks

Outcome Measure: Muscular Strength

Description:

Muscular strength will be assessed using the ALPHA-Fitness battery, including handgrip strength testing.

Unit of Measure:

kg

Interpretation:

Higher values indicate greater muscular strength and better physical fitness.

24 weeks
Assessment Agility
時間枠:24 weeks

Outcome Measure: Agility

Description:

Agility will be assessed using the ALPHA-Fitness battery, through a standardized agility and speed test.

Unit of Measure:

seconds

Interpretation:

Lower completion times indicate better agility, speed, and motor performance.

24 weeks
Assessment Cardiorespiratory Fitness
時間枠:24 weeks

Outcome Measure: Cardiorespiratory Fitness

Description:

Cardiorespiratory fitness will be assessed using the ALPHA-Fitness battery and expressed as estimated maximal oxygen consumption (VO₂max).

Unit of Measure:

mL/kg/min (VO₂max)

Interpretation:

Higher VO₂max values indicate better cardiorespiratory fitness and aerobic capacity. Lower values indicate poorer aerobic fitness.

24 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月20日

一次修了 (推定)

2026年6月30日

研究の完了 (推定)

2026年7月15日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月26日

最初の投稿 (実際)

2026年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月2日

QC基準を満たした最後の更新が送信されました

2026年6月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する