VR vs Treadmill Exercise in Children With Asthma
ConditionAsthma (Diagnosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorBezmialem Vakif University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-Based Aerobic Exercise
DeviceParticipants 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
Treadmill-Based Aerobic Exercise
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Treadmill Exercise GroupActive comparator 1 intervention
Group B: Virtual Reality-Based Exercise GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Capacity: 6-Minute Walk Test Distance
Functional capacity assessed by the 6-Minute Walk Test. The total distance covered during the test will be recorded in meters.
Time frame
Baseline and Week 8Secondary outcomes
1
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
Time frame
Baseline and Week 82
Forced Vital Capacity (FVC)
Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
Time frame
Baseline and Week 83
FEV1/FVC Ratio
Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
Time frame
Baseline and Week 84
Peak Expiratory Flow (PEF)
Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
Time frame
Baseline and Week 8Sponsors and contacts
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Source ClinicalTrials.gov