- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07576738
Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Children
4. května 2026 aktualizováno: Neslihan Torun Kızmaz, Hasan Kalyoncu University
Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Functional Capacity, Activity, and Participation in Children Between 6 and 10 Years of Age Under Protection and Care,
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation.
63 children between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study.
Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks.
The control group received no training and was asked to continue their normal lives.
All study participants were assessed before and after the 12-week training.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation.
63 children (Aerobic exercise=21, virtual reality-based game=21, control=21) between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study.
Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks.
The control group received no training and was asked to continue their normal lives.
All study participants were assessed before and after the 12-week training.
Functional capacity was assessed using the 6-minute walk test.
Body image measurements were assessed using the Physical Self-Assessment Scale.
Physical activity levels were assessed using the Physical Activity Scale.
Participation was assessed using the Child and Adolescent Participation Survey.
Typ studie
Intervenční
Zápis (Aktuální)
63
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Province
-
Gaziantep, Province, Turecko (Türkiye), 27410
- Hasan Kalyoncu University
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- The following volunteers participated in the study
- Children residing in the Şahinbey and Şehitkamil Children's Homes Complex,
- Participants aged between 6 and 10 years old.
Exclusion Criteria:
- Children with neurological and psychological illnesses severe enough to prevent participation in exercise training,
- Children who have undergone surgery within the last 3 months,
- Children with learning disabilities,
- Children who perform moderate-intensity aerobic exercise for more than 150 minutes at least 3 days a week,
- Children with multiple organ dysfunction were excluded from the study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: fonksiyonel kapasite
The 6-minute walk test was used to measure functional capacity.
This test is performed at the person's own walking speed.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
Children in this group were given virtual reality-based games twice a week for 12 weeks, totaling 24 sessions, under the supervision of a specialist physiotherapist.
Each session was planned to last 20-25 minutes.
There would be 4-5 repetitions depending on the difficulty level of the games, with 1-minute rest breaks between each repetition.
|
|
Aktivní komparátor: Fiziksel Aktivite Seviyesi
The Children's Physical Activity Scale was used to assess the physical activity levels of the children included in the study.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
Children in this group were given virtual reality-based games twice a week for 12 weeks, totaling 24 sessions, under the supervision of a specialist physiotherapist.
Each session was planned to last 20-25 minutes.
There would be 4-5 repetitions depending on the difficulty level of the games, with 1-minute rest breaks between each repetition.
|
|
Aktivní komparátor: katılım
Participation assessments were conducted using the Child and Adolescent Participation Questionnaire.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
Children in this group were given virtual reality-based games twice a week for 12 weeks, totaling 24 sessions, under the supervision of a specialist physiotherapist.
Each session was planned to last 20-25 minutes.
There would be 4-5 repetitions depending on the difficulty level of the games, with 1-minute rest breaks between each repetition.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
first review
Časové okno: 2 weeks before the start of the work
|
All children who agreed to participate in the study underwent initial assessments.
Functional capacity assessment was performed using the 6-minute walk test.
Body image measurements were assessed using the Physical Self-Concept Scale(min:1-max:5).
Physical activity levels were assessed using the Physical Activity Scale(min:1-max:5) Participation assessment was performed using the Child Adolescent Participation Questionnaire(min:0-max:4)
|
2 weeks before the start of the work
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
last review
Časové okno: Immediately after the completion of the 12-week training
|
Final assessments have been conducted for all children who completed the 12-week training period.
Functional capacity assessment was performed using the 6-minute walk test.
Body image measurements were assessed using the Physical Self-Concept Scale(min:1-max:6).
Physical activity levels were assessed using the Physical Activity Scale(min:1-max:5) Participation assessment was performed using the Child Adolescent Participation Questionnaire(min:0-max:4).
|
Immediately after the completion of the 12-week training
|
|
within-group comparison of results
Časové okno: When the final assessments are complete and all the data is collected
|
The evaluations conducted at the end of the study showed that both interventions were effective in terms of functional capacity(6- minute walk test), physical activity level( Physical Activity Scale(min:1-max:5).
participation (Child Adolescent Participation Questionnaire(min:0-max:4) body composition (Physical Self-Concept Scale min:1-max:6) and functionality parameters.
|
When the final assessments are complete and all the data is collected
|
|
comparison of results between groups
Časové okno: When the final assessments are complete and all the data is collected
|
In intergroup assessments, it was found that the aerobic exercise group was more effective than the virtual reality-based game group in activity, body structure and functionality, and participation assessments. It was found that the virtual reality-based game group was more effective than the aerobic exercise training group in activity, body structure and functionality, and participation assessments. |
When the final assessments are complete and all the data is collected
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: neslihan torun kızmaz, doctor physiotherapist, Hasan Kalyoncu University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2025
Primární dokončení (Aktuální)
15. září 2025
Dokončení studie (Aktuální)
1. prosince 2025
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
4. května 2026
První zveřejněno (Aktuální)
8. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HasanKUniversitesi
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .