VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)
20 de julho de 2026 atualizado por: Ayşe Sena Manzak, Bezmialem Vakif University
Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma
This study aims to compare the effects of virtual reality-based aerobic exercise and treadmill-based aerobic exercise on functional capacity, pulmonary function, and clinical outcomes in children with asthma.
Participants aged 10-17 years with physician-diagnosed asthma will be randomly assigned to either a virtual reality-based exercise group or a treadmill exercise group.
Both groups will undergo supervised exercise training sessions twice a week for 8 weeks.
Primary outcome will be the 6-Minute Walk Test.
Secondary outcomes include pulmonary function, respiratory muscle strength, asthma control, quality of life, and exercise adherence.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
Asthma is one of the most common chronic respiratory diseases in childhood and is associated with reduced physical activity, decreased functional capacity, and impaired quality of life. Regular aerobic exercise is recommended as part of asthma management; however, participation in exercise programs is often limited due to fear of symptom exacerbation and low motivation.
Virtual reality-based exercise programs have emerged as a novel approach to increase motivation and adherence in pediatric populations by integrating gamification into physical activity. Despite growing interest, there is limited evidence comparing virtual reality-based aerobic exercise with conventional aerobic exercise in children with asthma.
This prospective randomized controlled study will include children aged 10-17 years diagnosed with asthma. Participants will be randomly allocated into two groups: a virtual reality-based aerobic exercise group and a treadmill-based exercise group. Both groups will receive standardized asthma education prior to the intervention.
The intervention will consist of 40-minute sessions (5-minute warm-up, 30-minute main exercise, and 5-minute cool-down), performed twice weekly for 8 weeks. Functional capacity, pulmonary function, respiratory muscle strength, asthma control, and quality of life will be assessed before and after the intervention.
This study aims to evaluate whether virtual reality-based aerobic exercise can be an effective and engaging alternative to traditional aerobic exercise in pediatric asthma rehabilitation.
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ayşe Sena Manzak Dursun, PT, PhD
- Número de telefone: +905356735150
- E-mail: amanzak@bezmialem.edu.tr
Locais de estudo
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Eyupsultan
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Istanbul, Eyupsultan, Turquia (Türkiye)
- Recrutamento
- Bezmialem Vakif University
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Contato:
- Fuat Gokdemir, PT, MSc
- Número de telefone: +90 554 372 70 84
- E-mail: fuat.gokdemir@bezmialem.edu.tr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Children and adolescents aged between 10 and 17 years
- Physician-diagnosed asthma according to Global Initiative for Asthma (GINA) criteria
- Stable medical treatment for asthma
- Ability to participate in an aerobic exercise program
- Willingness of the participant and parent/legal guardian to provide informed consent
Exclusion Criteria:
- Presence of orthopedic, neurological, cardiovascular, or systemic conditions limiting participation in exercise
- Contraindications to virtual reality use (e.g., epilepsy, photosensitivity)
- Participation in a structured exercise program within the previous month
- Asthma exacerbation within the previous month
- Obesity diagnosis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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 |
|---|---|
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Comparador Ativo: Treadmill Exercise Group
Participants in this group will receive supervised moderate-intensity treadmill-based aerobic exercise sessions.
Each session will include a 5-minute warm-up, 30-minute aerobic exercise, and 5-minute cool-down period, performed twice weekly for 8 weeks.
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Participants will perform supervised moderate-intensity treadmill-based aerobic exercise.
Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period.
Sessions will be conducted twice weekly for 8 weeks.
|
|
Experimental: Virtual Reality-Based Exercise Group
Participants in this group will receive supervised virtual reality-based aerobic exercise sessions using a Meta Quest 3S headset and game-based activities.
Each session will include a 5-minute warm-up, 30-minute aerobic exercise, and 5-minute cool-down period, performed twice weekly for 8 weeks.
|
Participants will perform supervised moderate-intensity aerobic exercise using a Meta Quest 3S virtual reality headset and game-based activities.
Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period.
Sessions will be conducted twice weekly for 8 week
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Functional Capacity: 6-Minute Walk Test Distance
Prazo: Baseline and Week 8
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Functional capacity assessed by the 6-Minute Walk Test.
The total distance covered during the test will be recorded in meters.
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Baseline and Week 8
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline and Week 8
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Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Vital Capacity (FVC)
Prazo: Baseline and Week 8
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Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
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Baseline and Week 8
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FEV1/FVC Ratio
Prazo: Baseline and Week 8
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Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
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Baseline and Week 8
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Peak Expiratory Flow (PEF)
Prazo: Baseline and Week 8
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Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Expiratory Flow at 25-75% (FEF25-75)
Prazo: Baseline and Week 8
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Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.
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Baseline and Week 8
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Maximum Expiratory Pressure (MEP)
Prazo: Baseline and Week 8
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Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
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Baseline and Week 8
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Maximum Inspiratory Pressure (MIP)
Prazo: Baseline and Week 8
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Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
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Baseline and Week 8
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Asthma Control Test (ACT) Score
Prazo: Baseline and Week 8
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Asthma control assessed using the Asthma Control Test (ACT).
The ACT score ranges from 5 to 25, with higher scores indicating better asthma control.
Scores of 20-25 indicate well-controlled asthma, 16-19 indicate partially controlled asthma, and 5-15 indicate uncontrolled asthma.
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Baseline and Week 8
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Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score
Prazo: Baseline and Week 8
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Quality of life assessed using the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).
The questionnaire consists of 23 items across three domains: symptoms (10 items), emotional function (8 items), and activity limitation (5 items).
Each item is scored on a 7-point Likert scale ranging from 1 (severe impairment/limitation) to 7 (no impairment/limitation), with higher scores indicating better quality of life.
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Baseline and Week 8
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
25 de maio de 2026
Conclusão Primária (Estimado)
10 de maio de 2027
Conclusão do estudo (Estimado)
10 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2026
Primeira postagem (Real)
28 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026/50
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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