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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Physical Activity Level
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Capacity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- INU-TUSEB-54388
- 54388 (Jiné číslo grantu/financování: Türkiye Health Institutes Presidency (TÜSEB))
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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