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NCT Number: NCT07718763

Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Aerobic Exercise

Behavioral

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.

Virtual Reality-Based Aerobic Exercise

Behavioral

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.

Primary outcomes

  1. Physical Activity Level

    Time frame: Baseline and Week 8

    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).

Secondary outcomes

  1. Functional Capacity

    Time frame: 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

  2. Shoulder Abductor Muscle Strength

    Time frame: Baseline and Week 8

    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).

  3. Knee Extensor Muscle Strength

    Time frame: 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).

  4. Mean Heart Rate During Exercise

    Time frame: During each exercise session throughout the 8-week intervention

    Mean heart rate during each exercise session will be recorded using a Polar H10 heart rate monitor.

  5. Maximum Heart Rate During Exercise

    Time frame: During each exercise session throughout the 8-week intervention

    Maximum heart rate achieved during each exercise session will be recorded using a Polar H10 heart rate monitor.

  6. Percentage of Heart Rate Reserve

    Time frame: During each exercise session throughout the 8-week intervention

    Exercise intensity will be expressed as percentage of heart rate reserve (%HRR) calculated during each exercise session.

  7. Time Spent in Target Heart Rate Zone

    Time frame: During each exercise session throughout the 8-week intervention

    The percentage of exercise time spent within the prescribed target heart rate zone will be recorded during each exercise session.

  8. Digital Gaming Addiction Severity

    Time frame: Baseline and Week 8

    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.

  9. Exercise Enjoyment

    Time frame: Week 8

    Exercise enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES). Higher scores indicate greater enjoyment of physical activity.

  10. Intervention Usability

    Time frame: Week 8

    Intervention usability will be assessed using the System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating greater usability.

Sponsors and collaborators

Lead sponsor

Istanbul Nisantasi University

Other

Registry information

Official study title

Development and Preliminary Clinical Evaluation of a Physiological Biofeedback-Integrated Virtual Reality-Based Exercise Intervention for Young Adults at Risk of Digital Gaming Addiction

Acronym: VR-GAME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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