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

21 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

34

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Aktywny 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Physical Activity Level
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Functional Capacity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

25 września 2026

Zakończenie podstawowe (Szacowany)

25 marca 2027

Ukończenie studiów (Szacowany)

25 września 2027

Daty rejestracji na studia

Pierwszy przesłany

16 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2026

Pierwszy wysłany (Rzeczywisty)

22 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • INU-TUSEB-54388
  • 54388 (Inny numer grantu/finansowania: Türkiye Health Institutes Presidency (TÜSEB))

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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