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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

34

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: Traditional Aerobic Exercise
Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical Activity Level
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Capacity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul Nisantasi University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

25 settembre 2026

Completamento primario (Stimato)

25 marzo 2027

Completamento dello studio (Stimato)

25 settembre 2027

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INU-TUSEB-54388
  • 54388 (Altro numero di sovvenzione/finanziamento: Türkiye Health Institutes Presidency (TÜSEB))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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