- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07718763
Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction (VR-GAME)
Development and Preliminary Clinical Evaluation of a Physiological Biofeedback-Integrated Virtual Reality-Based Exercise Intervention for Young Adults at Risk of Digital Gaming Addiction
연구 개요
상태
정황
상세 설명
Digital game addiction is an emerging public health concern, particularly among young adults, and is associated with reduced physical activity, prolonged sedentary behavior, and adverse physical and psychosocial health outcomes. Innovative and engaging interventions are needed to promote physical activity in this population. Virtual reality (VR)-based exercise provides an immersive and motivating environment that may improve participation and adherence to exercise programs. Integrating physiological biofeedback into VR exercise may further optimize exercise intensity while enhancing safety and effectiveness.
This study aims to develop and conduct a preliminary clinical evaluation of a physiological biofeedback-integrated VR-based exercise intervention for young adults at risk of digital gaming addiction. The study is designed as a prospective, single-blind (outcome assessor), randomized controlled trial. Eligible participants will be randomly assigned to either a VR-based aerobic exercise group or a traditional aerobic exercise group. Both groups will participate in supervised exercise sessions twice weekly for 8 weeks, with each session lasting approximately 30 minutes. In the VR group, exercise intensity will be individualized using heart rate-based physiological biofeedback while participants perform immersive and interactive aerobic exercise under the supervision of a physiotherapist. Participants in the traditional exercise group will receive a structured aerobic exercise program matched for exercise intensity and duration.
The primary outcome is physical activity level. Secondary outcomes include functional capacity, muscle strength, physiological responses during exercise, digital gaming addiction severity, exercise enjoyment, and intervention usability. Outcomes will be assessed at baseline and after completion of the intervention using validated assessment tools. The findings of this study are expected to provide preliminary evidence regarding the feasibility and clinical effectiveness of physiological biofeedback-integrated VR-based exercise for young adults at risk of digital gaming addiction and contribute to the development of technology-assisted exercise interventions for this population.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Young adults within the eligible age range specified in the study protocol.
- Currently enrolled as a university student.
- Playing online digital games for at least 2 hours per day.
- Internet Gaming Disorder Scale-Short Form (IGDS9-SF) score ≥32.
- Apparently healthy with no diagnosed chronic disease.
- Able to participate in moderate-intensity aerobic exercise.
- Willing to provide written informed consent.
Exclusion Criteria:
- Presence of cardiovascular, respiratory, neurological, musculoskeletal, or other medical conditions that may interfere with safe participation in exercise.
- Use of medications that may affect exercise performance or physiological responses.
- History of injury or surgery within the previous 6 months that may limit physical activity.
- Contraindications to aerobic exercise or virtual reality use.
- Inability to complete the study procedures or refusal to provide informed consent.
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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실험적: Virtual Reality-Based Aerobic Exercise
Participants will receive a supervised virtual reality-based aerobic exercise program integrated with physiological biofeedback twice weekly for 8 weeks.
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Participants will perform supervised aerobic exercise in an immersive virtual reality environment twice weekly for 8 weeks.
Exercise intensity will be individualized using heart rate-based physiological biofeedback and progressively adjusted according to participants' physiological responses.
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활성 비교기: Traditional Aerobic Exercise
Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks.
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Participants will perform a supervised structured aerobic exercise program twice weekly for 8 weeks.
Exercise intensity will be individualized according to target heart rate and progressively adjusted throughout the intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical Activity Level
기간: Baseline and Week 8
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Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
The primary outcome will be the total physical activity score expressed as metabolic equivalent minutes per week (MET-min/week).
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Baseline and Week 8
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional Capacity
기간: Baseline and Week 8
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Functional capacity will be assessed using the 6-Minute Walk Test (6MWT).
The total walking distance (meters) covered in six minutes will be recorded
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Baseline and Week 8
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Shoulder Abductor Muscle Strength
기간: Baseline and Week 8
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Maximum isometric strength of the dominant shoulder abductors will be measured using a handheld dynamometer.
The highest value of three trials will be recorded in Newtons (N).
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Baseline and Week 8
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Knee Extensor Muscle Strength
기간: Baseline and Week 8
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Maximum isometric strength of the dominant knee extensors will be measured using a handheld dynamometer.
The highest value of three trials will be recorded in Newtons (N).
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Baseline and Week 8
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Mean Heart Rate During Exercise
기간: During each exercise session throughout the 8-week intervention
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Mean heart rate during each exercise session will be recorded using a Polar H10 heart rate monitor.
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During each exercise session throughout the 8-week intervention
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Maximum Heart Rate During Exercise
기간: During each exercise session throughout the 8-week intervention
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Maximum heart rate achieved during each exercise session will be recorded using a Polar H10 heart rate monitor.
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During each exercise session throughout the 8-week intervention
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Percentage of Heart Rate Reserve
기간: During each exercise session throughout the 8-week intervention
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Exercise intensity will be expressed as percentage of heart rate reserve (%HRR) calculated during each exercise session.
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During each exercise session throughout the 8-week intervention
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Time Spent in Target Heart Rate Zone
기간: During each exercise session throughout the 8-week intervention
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The percentage of exercise time spent within the prescribed target heart rate zone will be recorded during each exercise session.
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During each exercise session throughout the 8-week intervention
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Digital Gaming Addiction Severity
기간: Baseline and Week 8
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Digital gaming addiction severity will be assessed using the Internet Gaming Disorder Scale-Short Form (IGDS9-SF).
Higher scores indicate greater digital gaming addiction severity.
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Baseline and Week 8
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Exercise Enjoyment
기간: Week 8
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Exercise enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES).
Higher scores indicate greater enjoyment of physical activity.
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Week 8
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Intervention Usability
기간: Week 8
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Intervention usability will be assessed using the System Usability Scale (SUS).
Scores range from 0 to 100, with higher scores indicating greater usability.
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Week 8
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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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