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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill Exercise Group | Active Comparator | 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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| Virtual Reality-Based Exercise Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality-Based Aerobic Exercise | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayşe Sena Manzak Dursun, PT, PhD | Contact | +905356735150 | amanzak@bezmialem.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | Eyupsultan | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Participants will be randomly assigned to one of two parallel groups: a virtual reality-based aerobic exercise group or a treadmill-based aerobic exercise group. Both groups will receive supervised exercise sessions twice weekly for 8 weeks and will undergo pre- and post-intervention assessments.
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Due to the nature of the exercise interventions, participants, care providers, and investigators cannot be blinded. However, outcome assessments will be performed by an independent assessor blinded to group allocation.
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| Treadmill-Based Aerobic Exercise | Behavioral | 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. |
|
Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
| Baseline and Week 8 |
| FEV1/FVC Ratio | Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%). | Baseline and Week 8 |
| Peak Expiratory Flow (PEF) | 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) | 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) | Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O. | Baseline and Week 8 |
| Maximum Inspiratory Pressure (MIP) | Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O. | Baseline and Week 8 |
| Asthma Control Test (ACT) Score | 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 | 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |