Asthma (Diagnosis)VR-ASTHMANCT07610447
VR vs Treadmill Exercise in Children With Asthma
A study testing Virtual Reality-Based Aerobic Exercise and Treadmill-Based Aerobic Exercise in people with Asthma (Diagnosis), run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Virtual Reality-Based Aerobic Exercise and Treadmill-Based Aerobic Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2026to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Eyupsultan
Fuat Gokdemir, PT, MSc, +90 554 372 70 84, fuat.gokdemir@bezmialem.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Virtual Reality-Based Aerobic Exercise, Treadmill-Based Aerobic Exercise
- Keywords
- Virtual Reality, Asthma, Aerobic Exercise, Pediatric Pulmonology, Exercise Training, Treadmill
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Aerobic ExerciseDevice
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treadmill-Based Aerobic Exercise |
| 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. Receives: Device: Virtual Reality-Based Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (9)
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
Measured: Baseline and Week 8
Forced Vital Capacity (FVC)
Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
Measured: Baseline and Week 8
FEV1/FVC Ratio
Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
Measured: Baseline and Week 8
Peak Expiratory Flow (PEF)
Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
Measured: 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.
Measured: Baseline and Week 8
Maximum Expiratory Pressure (MEP)
Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
Measured: Baseline and Week 8
Maximum Inspiratory Pressure (MIP)
Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start25 May 2026
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sena Manzak, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610447
- Sponsor's protocol ID
- 2026/50
- Acronym
- VR-ASTHMA
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma
- ClinicalTrials.gov ID
- NCT07610447
- Acronym / sponsor ID
- VR-ASTHMA / 2026/50
- Conditions
- Asthma (Diagnosis)
- Keywords
- Virtual Reality, Asthma, Aerobic Exercise, Pediatric Pulmonology, Exercise Training, Treadmill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treadmill Exercise Group | Active comparator | Behavioral: Treadmill-Based Aerobic ExerciseParticipants 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. |
| Virtual Reality-Based Exercise Group | Experimental | Device: Virtual Reality-Based Aerobic ExerciseParticipants 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Aerobic ExerciseParticipants 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 | Device | Virtual Reality-Based Exercise Group |
| Treadmill-Based Aerobic ExerciseParticipants 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. | Behavioural | Treadmill Exercise Group |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Related trials for Asthma (Diagnosis)
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Aerobic Exercise and Treadmill-Based Aerobic Exercise in people with Asthma (Diagnosis), run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Sena Manzak Dursun, PT, PhD (+905356735150, amanzak@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity: 6-Minute Walk Test Distance (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.