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Recruiting NCT07610447

VR vs Treadmill Exercise in Children With Asthma

No phase Interventional Asthma (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-Based Aerobic Exercise, Treadmill-Based Aerobic Exercise.
Who it may be relevant to
Registry conditions: Asthma (Diagnosis). Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma

Overview

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.

Detailed description

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.

Interventions

  • Device 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
  • Behavioral 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.

Primary outcome measures

  • Functional Capacity: 6-Minute Walk Test Distance [Time frame: Baseline and Week 8]
Secondary outcome measures (9)
  • Forced Expiratory Volume in 1 Second (FEV1) [Time frame: Baseline and Week 8]
  • Forced Vital Capacity (FVC) [Time frame: Baseline and Week 8]
  • FEV1/FVC Ratio [Time frame: Baseline and Week 8]
  • Peak Expiratory Flow (PEF) [Time frame: Baseline and Week 8]
  • Forced Expiratory Flow at 25-75% (FEF25-75) [Time frame: Baseline and Week 8]
  • Maximum Expiratory Pressure (MEP) [Time frame: Baseline and Week 8]
  • Maximum Inspiratory Pressure (MIP) [Time frame: Baseline and Week 8]
  • Asthma Control Test (ACT) Score [Time frame: Baseline and Week 8]
  • Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score [Time frame: Baseline and Week 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bezmialem Vakif University — Istanbul

Identifiers

NCT: NCT07610447 · 2026/50

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗