NCT07610447

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026May 2027

First Submitted

Initial submission to the registry

May 15, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 15, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

Virtual RealityAsthmaAerobic ExercisePediatric PulmonologyExercise TrainingTreadmill

Outcome Measures

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.

    Baseline and Week 8

Secondary Outcomes (9)

  • Forced Expiratory Volume in 1 Second (FEV1)

    Baseline and Week 8

  • Forced Vital Capacity (FVC)

    Baseline and Week 8

  • FEV1/FVC Ratio

    Baseline and Week 8

  • Peak Expiratory Flow (PEF)

    Baseline and Week 8

  • Forced Expiratory Flow at 25-75% (FEF25-75)

    Baseline and Week 8

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Device: Virtual Reality-Based Aerobic Exercise

Interventions

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

Virtual Reality-Based Exercise Group

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.

Treadmill Exercise Group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyupsultan, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AsthmaDisease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ayşe Sena Manzak Dursun, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 28, 2026

Study Start

May 25, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

May 10, 2027

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations