- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07718763
Virtual Reality Exercise for Young Adults at Risk of Digital Gaming Addiction (VR-GAME)
Development and Preliminary Clinical Evaluation of a Physiological Biofeedback-Integrated Virtual Reality-Based Exercise Intervention for Young Adults at Risk of Digital Gaming Addiction
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Physical Activity Level
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Capacity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- INU-TUSEB-54388
- 54388 (Número de outro subsídio/financiamento: Türkiye Health Institutes Presidency (TÜSEB))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .