- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07610447
VR vs Treadmill Exercise in Children With Asthma (VR-ASTHMA)
Comparison of Treadmill and Virtual Reality-Based Aerobic Exercise Programs in Children With Asthma
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ayşe Sena Manzak Dursun, PT, PhD
- Puhelinnumero: +905356735150
- Sähköposti: amanzak@bezmialem.edu.tr
Opiskelupaikat
-
-
Eyupsultan
-
Istanbul, Eyupsultan, Turkki (Türkiye)
- Rekrytointi
- Bezmialem Vakif University
-
Ottaa yhteyttä:
- Fuat Gokdemir, PT, MSc
- Puhelinnumero: +90 554 372 70 84
- Sähköposti: fuat.gokdemir@bezmialem.edu.tr
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
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.
|
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.
|
|
Kokeellinen: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Functional Capacity: 6-Minute Walk Test Distance
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: Baseline and Week 8
|
Respiratory muscle strength assessed using maximal expiratory pressure (MEP), expressed in cmH₂O.
|
Baseline and Week 8
|
|
Maximum Inspiratory Pressure (MIP)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2026/50
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .