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Not yet recruiting NCT07718763

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

No phase Interventional Internet Gaming Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional Aerobic Exercise, Virtual Reality-Based Aerobic Exercise.
Who it may be relevant to
Registry conditions: Internet Gaming Disorder. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Traditional Aerobic Exercise
    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.
  • Behavioral Virtual Reality-Based Aerobic Exercise
    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 outcome measures

  • Physical Activity Level [Time frame: Baseline and Week 8]
Secondary outcome measures (10)
  • Functional Capacity [Time frame: Baseline and Week 8]
  • Shoulder Abductor Muscle Strength [Time frame: Baseline and Week 8]
  • Knee Extensor Muscle Strength [Time frame: Baseline and Week 8]
  • Mean Heart Rate During Exercise [Time frame: During each exercise session throughout the 8-week intervention]
  • Maximum Heart Rate During Exercise [Time frame: During each exercise session throughout the 8-week intervention]
  • Percentage of Heart Rate Reserve [Time frame: During each exercise session throughout the 8-week intervention]
  • Time Spent in Target Heart Rate Zone [Time frame: During each exercise session throughout the 8-week intervention]
  • Digital Gaming Addiction Severity [Time frame: Baseline and Week 8]
  • Exercise Enjoyment [Time frame: Week 8]
  • Intervention Usability [Time frame: Week 8]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07718763 · INU-TUSEB-54388 · 54388

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗