VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)
20 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ayşe Sena Manzak Dursun, PT, PhD
- Numero di telefono: +905356735150
- Email: amanzak@bezmialem.edu.tr
Luoghi di studio
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Eyupsultan
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Istanbul, Eyupsultan, Turchia (Türkiye)
- Reclutamento
- Bezmialem Vakif University
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Contatto:
- Fuat Gokdemir, PT, MSc
- Numero di telefono: +90 554 372 70 84
- Email: fuat.gokdemir@bezmialem.edu.tr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
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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.
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Sperimentale: 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.
|
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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional Capacity: 6-Minute Walk Test Distance
Lasso di tempo: Baseline and Week 8
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Functional capacity assessed by the 6-Minute Walk Test.
The total distance covered during the test will be recorded in meters.
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Baseline and Week 8
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: Baseline and Week 8
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Pulmonary function assessed by forced expiratory volume in 1 second (FEV1), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Vital Capacity (FVC)
Lasso di tempo: Baseline and Week 8
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Pulmonary function assessed by forced vital capacity (FVC), expressed as percentage of predicted value.
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Baseline and Week 8
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FEV1/FVC Ratio
Lasso di tempo: Baseline and Week 8
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Pulmonary function assessed by FEV1/FVC ratio, expressed as percentage of predicted value or ratio (%).
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Baseline and Week 8
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Peak Expiratory Flow (PEF)
Lasso di tempo: Baseline and Week 8
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Pulmonary function assessed by peak expiratory flow (PEF), expressed as percentage of predicted value.
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Baseline and Week 8
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Forced Expiratory Flow at 25-75% (FEF25-75)
Lasso di tempo: Baseline and Week 8
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Pulmonary function assessed by forced expiratory flow at 25-75% (FEF25-75), expressed as percentage of predicted value.
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Baseline and Week 8
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Maximum Expiratory Pressure (MEP)
Lasso di tempo: Baseline and Week 8
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Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
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Baseline and Week 8
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Maximum Inspiratory Pressure (MIP)
Lasso di tempo: Baseline and Week 8
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Respiratory muscle strength assessed using maximal inspiratory pressure (MIP), expressed in cmH₂O.
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Baseline and Week 8
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Asthma Control Test (ACT) Score
Lasso di tempo: Baseline and Week 8
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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.
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Baseline and Week 8
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Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score
Lasso di tempo: Baseline and Week 8
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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.
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Baseline and Week 8
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
25 maggio 2026
Completamento primario (Stimato)
10 maggio 2027
Completamento dello studio (Stimato)
10 maggio 2027
Date di iscrizione allo studio
Primo inviato
15 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 maggio 2026
Primo Inserito (Effettivo)
28 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/50
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .