Development and Preliminary Clinical Evaluation of a Physiological Biofeedback-Integrated Virtual Reality-Based Exercise Intervention for Young Adults at Risk of Digital Gaming Addiction
| Registry | NCT07718763, acronym VR-GAME |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 34 (Estimated) |
| Sponsor | Istanbul Nisantasi University (Other) |
| Conditions | Internet Gaming Disorder |
| Interventions | Traditional Aerobic Exercise, Virtual Reality-Based Aerobic Exercise (Behavioral) |
| Dates | start 2026-09-25 (estimated), primary completion 2027-03-25 (estimated), completion 2027-09-25 (estimated), first posted 2026-07-22, last updated 2026-07-22 |
Related Papers Related Patents Related Grants Related Experts
All trials for Internet Gaming Disorder All trials of Traditional Aerobic Exercise All trials of Virtual Reality-Based Aerobic Exercise
Digital game addiction is associated with reduced physical activity, increased sedentary behavior, and adverse physical and psychosocial health outcomes in young adults. This study aims to develop and evaluate the effectiveness of a physiological biofeedback-integrated virtual reality (VR)-based exercise intervention for young adults at risk of digital gaming addiction. In this prospective, single-blind, randomized controlled trial, 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. The primary outcome is physical activity level, while secondary outcomes include functional capacity, muscle strength, physiological responses during exercise, digital gaming addiction severity, exercise enjoyment, and intervention usability.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virtual Reality-Based Aerobic Exercise | Experimental | Behavioral: 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. |
| Traditional Aerobic Exercise | Active comparator | Behavioral: Traditional Aerobic Exercise | Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks. |
Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers
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.