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

May 22, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8
Forced Vital Capacity (FVC)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline and Week 8
Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
Baseline and Week 8
Maximum Inspiratory Pressure (MIP)
Time Frame: 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
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.
Baseline and Week 8
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.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 25, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

May 10, 2027

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026/50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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