- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07610447
VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)
Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ayşe Sena Manzak Dursun, PT, PhD
- 전화번호: +905356735150
- 이메일: amanzak@bezmialem.edu.tr
연구 장소
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Eyupsultan
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Istanbul, Eyupsultan, 터키 (Türkiye)
- 모병
- Bezmialem Vakif University
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연락하다:
- Fuat Gokdemir, PT, MSc
- 전화번호: +90 554 372 70 84
- 이메일: fuat.gokdemir@bezmialem.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional Capacity: 6-Minute Walk Test Distance
기간: Baseline and Week 8
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Functional capacity assessed by the 6-Minute Walk Test.
The total distance covered during the test will be recorded in meters.
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Baseline and Week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Forced Expiratory Volume in 1 Second (FEV1)
기간: Baseline and Week 8
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Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Vital Capacity (FVC)
기간: Baseline and Week 8
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Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
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Baseline and Week 8
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FEV1/FVC Ratio
기간: Baseline and Week 8
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Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
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Baseline and Week 8
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Peak Expiratory Flow (PEF)
기간: Baseline and Week 8
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Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Expiratory Flow at 25-75% (FEF25-75)
기간: Baseline and Week 8
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Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.
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Baseline and Week 8
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Maximum Expiratory Pressure (MEP)
기간: Baseline and Week 8
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Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
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Baseline and Week 8
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Maximum Inspiratory Pressure (MIP)
기간: Baseline and Week 8
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Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
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Baseline and Week 8
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Asthma Control Test (ACT) Score
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score
기간: Baseline and Week 8
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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.
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Baseline and Week 8
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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