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Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction (VR-GAME)

21. juli 2026 opdateret af: Elif Aleyna Yazgan, Istanbul Nisantasi University

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

34

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Aktiv komparator: Traditional Aerobic Exercise
Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Activity Level
Tidsramme: 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).
Baseline and Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Capacity
Tidsramme: 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
Baseline and Week 8
Shoulder Abductor Muscle Strength
Tidsramme: 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).
Baseline and Week 8
Knee Extensor Muscle Strength
Tidsramme: 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).
Baseline and Week 8
Mean Heart Rate During Exercise
Tidsramme: 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.
During each exercise session throughout the 8-week intervention
Maximum Heart Rate During Exercise
Tidsramme: 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.
During each exercise session throughout the 8-week intervention
Percentage of Heart Rate Reserve
Tidsramme: 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.
During each exercise session throughout the 8-week intervention
Time Spent in Target Heart Rate Zone
Tidsramme: 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.
During each exercise session throughout the 8-week intervention
Digital Gaming Addiction Severity
Tidsramme: 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.
Baseline and Week 8
Exercise Enjoyment
Tidsramme: Week 8
Exercise enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES). Higher scores indicate greater enjoyment of physical activity.
Week 8
Intervention Usability
Tidsramme: 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.
Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. september 2026

Primær færdiggørelse (Anslået)

25. marts 2027

Studieafslutning (Anslået)

25. september 2027

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • INU-TUSEB-54388
  • 54388 (Andet bevillings-/finansieringsnummer: Türkiye Health Institutes Presidency (TÜSEB))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Internet Gaming Disorder

Kliniske forsøg med Virtual Reality-Based Aerobic Exercise

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