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NCT Number: NCT07610447

VR vs Treadmill Exercise 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.

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Key information

Conditions

Asthma (Diagnosis) Asthma Bronchial Diseases Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Eyupsultan, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fuat Gokdemir, PT, MSc

CONTACT

[email protected]

+90 554 372 70 84

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Functional Capacity: 6-Minute Walk Test Distance

    Time frame: 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.

Secondary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline and Week 8

    Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.

  2. Forced Vital Capacity (FVC)

    Time frame: Baseline and Week 8

    Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.

  3. FEV1/FVC Ratio

    Time frame: Baseline and Week 8

    Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).

  4. Peak Expiratory Flow (PEF)

    Time frame: Baseline and Week 8

    Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.

  5. Forced Expiratory Flow at 25-75% (FEF25-75)

    Time frame: Baseline and Week 8

    Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.

  6. Maximum Expiratory Pressure (MEP)

    Time frame: Baseline and Week 8

    Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.

  7. Maximum Inspiratory Pressure (MIP)

    Time frame: Baseline and Week 8

    Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.

  8. Asthma Control Test (ACT) Score

    Time frame: 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.

  9. Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Sena Manzak Dursun, PT, PhD

CONTACT

[email protected]

+905356735150

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: VR-ASTHMA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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