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VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)

2026年7月20日 更新者：Ayşe Sena Manzak、Bezmialem Vakif University

Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma

This study aims to compare the effects of virtual reality-based aerobic exercise and treadmill-based aerobic exercise on functional capacity, pulmonary function, and clinical outcomes in children with asthma. Participants aged 10-17 years with physician-diagnosed asthma will be randomly assigned to either a virtual reality-based exercise group or a treadmill exercise group. Both groups will undergo supervised exercise training sessions twice a week for 8 weeks. Primary outcome will be the 6-Minute Walk Test. Secondary outcomes include pulmonary function, respiratory muscle strength, asthma control, quality of life, and exercise adherence.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Asthma is one of the most common chronic respiratory diseases in childhood and is associated with reduced physical activity, decreased functional capacity, and impaired quality of life. Regular aerobic exercise is recommended as part of asthma management; however, participation in exercise programs is often limited due to fear of symptom exacerbation and low motivation.

Virtual reality-based exercise programs have emerged as a novel approach to increase motivation and adherence in pediatric populations by integrating gamification into physical activity. Despite growing interest, there is limited evidence comparing virtual reality-based aerobic exercise with conventional aerobic exercise in children with asthma.

This prospective randomized controlled study will include children aged 10-17 years diagnosed with asthma. Participants will be randomly allocated into two groups: a virtual reality-based aerobic exercise group and a treadmill-based exercise group. Both groups will receive standardized asthma education prior to the intervention.

The intervention will consist of 40-minute sessions (5-minute warm-up, 30-minute main exercise, and 5-minute cool-down), performed twice weekly for 8 weeks. Functional capacity, pulmonary function, respiratory muscle strength, asthma control, and quality of life will be assessed before and after the intervention.

This study aims to evaluate whether virtual reality-based aerobic exercise can be an effective and engaging alternative to traditional aerobic exercise in pediatric asthma rehabilitation.

研究の種類

介入

入学 (推定)

30

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。

研究連絡先

研究場所

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:

  • Children and adolescents aged between 10 and 17 years
  • Physician-diagnosed asthma according to Global Initiative for Asthma (GINA) criteria
  • Stable medical treatment for asthma
  • Ability to participate in an aerobic exercise program
  • Willingness of the participant and parent/legal guardian to provide informed consent

Exclusion Criteria:

  • Presence of orthopedic, neurological, cardiovascular, or systemic conditions limiting participation in exercise
  • Contraindications to virtual reality use (e.g., epilepsy, photosensitivity)
  • Participation in a structured exercise program within the previous month
  • Asthma exacerbation within the previous month
  • Obesity diagnosis

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：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Treadmill Exercise Group
Participants in this group will receive supervised moderate-intensity treadmill-based aerobic exercise sessions. Each session will include a 5-minute warm-up, 30-minute aerobic exercise, and 5-minute cool-down period, performed twice weekly for 8 weeks.
行動：Treadmill-Based Aerobic Exercise
Participants will perform supervised moderate-intensity treadmill-based aerobic exercise. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 weeks.
実験的：Virtual Reality-Based Exercise Group
Participants in this group will receive supervised virtual reality-based aerobic exercise sessions using a Meta Quest 3S headset and game-based activities. Each session will include a 5-minute warm-up, 30-minute aerobic exercise, and 5-minute cool-down period, performed twice weekly for 8 weeks.
デバイス：Virtual Reality-Based Aerobic Exercise
Participants will perform supervised moderate-intensity aerobic exercise using a Meta Quest 3S virtual reality headset and game-based activities. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 week

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
Functional Capacity: 6-Minute Walk Test Distance
時間枠：Baseline and Week 8
Functional capacity assessed by the 6-Minute Walk Test. The total distance covered during the test will be recorded in meters.
Baseline and Week 8

二次結果の測定

結果測定
メジャーの説明
時間枠
Forced Expiratory Volume in 1 Second (FEV1)
時間枠：Baseline and Week 8
Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
Baseline and Week 8
Forced Vital Capacity (FVC)
時間枠：Baseline and Week 8
Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
Baseline and Week 8
FEV1/FVC Ratio
時間枠：Baseline and Week 8
Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
Baseline and Week 8
Peak Expiratory Flow (PEF)
時間枠：Baseline and Week 8
Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
Baseline and Week 8
Forced Expiratory Flow at 25-75% (FEF25-75)
時間枠：Baseline and Week 8
Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.
Baseline and Week 8
Maximum Expiratory Pressure (MEP)
時間枠：Baseline and Week 8
Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
Baseline and Week 8
Maximum Inspiratory Pressure (MIP)
時間枠：Baseline and Week 8
Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
Baseline and Week 8
Asthma Control Test (ACT) Score
時間枠：Baseline and Week 8
Asthma control assessed using the Asthma Control Test (ACT). The ACT score ranges from 5 to 25, with higher scores indicating better asthma control. Scores of 20-25 indicate well-controlled asthma, 16-19 indicate partially controlled asthma, and 5-15 indicate uncontrolled asthma.
Baseline and Week 8
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score
時間枠：Baseline and Week 8
Quality of life assessed using the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The questionnaire consists of 23 items across three domains: symptoms (10 items), emotional function (8 items), and activity limitation (5 items). Each item is scored on a 7-point Likert scale ranging from 1 (severe impairment/limitation) to 7 (no impairment/limitation), with higher scores indicating better quality of life.
Baseline and Week 8

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。

スポンサー

Bezmialem Vakif University

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5月25日

一次修了 (推定)

2027年5月10日

研究の完了 (推定)

2027年5月10日

試験登録日

最初に提出

2026年5月15日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026/50

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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

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