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VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)

20 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ayşe Sena Manzak Dursun, PT, PhD
  • Número de teléfono: +905356735150
  • Correo electrónico: amanzak@bezmialem.edu.tr

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Conductual: Treadmill-Based Aerobic Exercise
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.
Dispositivo: Virtual Reality-Based Aerobic Exercise
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Capacity: 6-Minute Walk Test Distance
Periodo de tiempo: Baseline and Week 8
Functional capacity assessed by the 6-Minute Walk Test. The total distance covered during the test will be recorded in meters.
Baseline and Week 8

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: Baseline and Week 8
Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
Baseline and Week 8
Forced Vital Capacity (FVC)
Periodo de tiempo: Baseline and Week 8
Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
Baseline and Week 8
FEV1/FVC Ratio
Periodo de tiempo: Baseline and Week 8
Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
Baseline and Week 8
Peak Expiratory Flow (PEF)
Periodo de tiempo: Baseline and Week 8
Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
Baseline and Week 8
Forced Expiratory Flow at 25-75% (FEF25-75)
Periodo de tiempo: Baseline and Week 8
Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.
Baseline and Week 8
Maximum Expiratory Pressure (MEP)
Periodo de tiempo: Baseline and Week 8
Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
Baseline and Week 8
Maximum Inspiratory Pressure (MIP)
Periodo de tiempo: Baseline and Week 8
Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
Baseline and Week 8
Asthma Control Test (ACT) Score
Periodo de tiempo: Baseline and Week 8
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.
Baseline and Week 8
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score
Periodo de tiempo: Baseline and Week 8
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.
Baseline and Week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bezmialem Vakif University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de mayo de 2026

Finalización primaria (Estimado)

10 de mayo de 2027

Finalización del estudio (Estimado)

10 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026/50

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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