- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07576738
Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Children
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,
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Province
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Gaziantep, Province, Tyrkiet (Türkiye), 27410
- Hasan Kalyoncu University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
first review
Tidsramme: 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)
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2 weeks before the start of the work
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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last review
Tidsramme: Immediately after the completion of the 12-week training
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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).
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Immediately after the completion of the 12-week training
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within-group comparison of results
Tidsramme: When the final assessments are complete and all the data is collected
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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.
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When the final assessments are complete and all the data is collected
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comparison of results between groups
Tidsramme: When the final assessments are complete and all the data is collected
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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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: neslihan torun kızmaz, doctor physiotherapist, Hasan Kalyoncu University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HasanKUniversitesi
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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