Internet Gaming DisorderVR-GAMENCT07718763
Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction
A study testing Traditional Aerobic Exercise and Virtual Reality-Based Aerobic Exercise in people with Internet Gaming Disorder, run by Istanbul Nisantasi University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Traditional Aerobic Exercise and Virtual Reality-Based Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to 25 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Internet Gaming Disorder
- Being tested
- Traditional Aerobic Exercise, Virtual Reality-Based Aerobic Exercise
- Keywords
- Virtual Reality, Physiological Biofeedback, Exercise, Digital Gaming Addiction
- Medical subject headings
- Internet Addiction Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Aerobic ExerciseBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Aerobic Exercise | Experimental | Participants will receive a supervised virtual reality-based aerobic exercise program integrated with physiological biofeedback twice weekly for 8 weeks. Receives: Behavioral: Virtual Reality-Based Aerobic Exercise |
| Traditional Aerobic Exercise | Active comparator | Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks. Receives: Behavioral: Traditional Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
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).
Measured: Baseline and Week 8
Secondary outcomes (10)
Functional Capacity
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). The total walking distance (meters) covered in six minutes will be recorded
Measured: Baseline and Week 8
Shoulder Abductor Muscle Strength
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).
Measured: Baseline and Week 8
Knee Extensor Muscle Strength
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).
Measured: Baseline and Week 8
Mean Heart Rate During Exercise
Mean heart rate during each exercise session will be recorded using a Polar H10 heart rate monitor.
Measured: During each exercise session throughout the 8-week intervention
Maximum Heart Rate During Exercise
Maximum heart rate achieved during each exercise session will be recorded using a Polar H10 heart rate monitor.
Measured: During each exercise session throughout the 8-week intervention
Percentage of Heart Rate Reserve
Exercise intensity will be expressed as percentage of heart rate reserve (%HRR) calculated during each exercise session.
Measured: During each exercise session throughout the 8-week intervention
Time Spent in Target Heart Rate Zone
The percentage of exercise time spent within the prescribed target heart rate zone will be recorded during each exercise session.
Measured: During each exercise session throughout the 8-week intervention
Digital Gaming Addiction Severity
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.
Measured: Baseline and Week 8
Exercise Enjoyment
Exercise enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES). Higher scores indicate greater enjoyment of physical activity.
Measured: Week 8
Intervention Usability
Intervention usability will be assessed using the System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating greater usability.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start25 Sep 2026 (estimated)
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a virtual reality-based aerobic exercise group or a traditional aerobic exercise group. Both groups will receive supervised aerobic exercise twice weekly for 8 weeks. Exercise intensity in the virtual reality group will be individualized using heart rate-based physiological biofeedback.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Aleyna Yazgan, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718763
- Sponsor's protocol ID
- INU-TUSEB-54388
- Other IDs
- 54388
- Acronym
- VR-GAME
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07718763
- Acronym / sponsor ID
- VR-GAME / INU-TUSEB-54388
- Conditions
- Internet Gaming Disorder
- Keywords
- Virtual Reality, Physiological Biofeedback, Exercise, Digital Gaming Addiction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a virtual reality-based aerobic exercise group or a traditional aerobic exercise group. Both groups will receive supervised aerobic exercise twice weekly for 8 weeks. Exercise intensity in the virtual reality group will be individualized using heart rate-based physiological biofeedback.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Aerobic Exercise | Experimental | Behavioral: Virtual Reality-Based Aerobic ExerciseParticipants 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 ExerciseParticipants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Aerobic ExerciseParticipants 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. | Behavioural | Traditional Aerobic Exercise |
| Virtual Reality-Based Aerobic ExerciseParticipants 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. | Behavioural | Virtual Reality-Based Aerobic Exercise |
Primary outcome
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).
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Aerobic Exercise and Virtual Reality-Based Aerobic Exercise in people with Internet Gaming Disorder, run by Istanbul Nisantasi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.