- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical Activity Level
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Capacity
Periodo de tiempo: Baseline and Week 8
|
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 8
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INU-TUSEB-54388
- 54388 (Otro número de subvención/financiamiento: Türkiye Health Institutes Presidency (TÜSEB))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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