- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05020041
Change Physical Activity and School Play Space. Randomized Study Protocol. (Play&Cognition)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Región Del Maule
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Talca, Región Del Maule, Chile, 3467987
- Universidad Autónoma de Chile
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- The inclusion criteria for the participating students are a) children enrolled in 1st-grade in municipal schools in the city of Talca; b) without impediments to physical activity; c) able to understand an order considering their age; d) residents in the commune of Talca; and e) with a commitment not to change school or residence during the duration of the project.
Exclusion Criteria:
- The exclusion criteria are presenting any medical condition that prevents the development of the evaluations and/or presenting any behavioral disorder condition.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
The implementation of painted games will consist of adapting a space destined for recreation, designing a psychomotor circuit that does not require contact between peers, or manipulation of objects to maintain COVID-19 sanitary and safety protocols. The schools in the intervention group will receive the online educational talk aimed at schoolchildren and a talk aimed at Physical Education teachers. |
The schools in the intervention group will receive the online educational talk aimed at schoolchildren and a talk aimed at Physical Education teachers, given that they are fundamental for the development of habits in the school stage; besides, painted games will be implemented in the school playground. The implementation of painted games will consist of adapting a space destined for recreation, designing a psychomotor circuit that does not require contact between peers or manipulation of objects in order to maintain COVID-19 sanitary and safety protocols. The psychomotor circuit includes a line circuit, a jumping sequence game, and a letter spiral. All the games will be implemented in a space within the educational establishment to which the students will have access during recess. The game designs involve activities to develop motor patterns such as jumping with different supports, running, and dynamic balance.
Andre navne:
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Ingen indgriben: Control
The schools participating in the control group will receive an online educational talk aimed at promoting healthy habits and the benefits of physical activity inside and outside the school environment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Physical activity
Tidsramme: change baseline up to 5 months
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Accelerometry data will be valid if they present ≥ 3 days of measurement with a minimum of 9 hours of use per day.
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change baseline up to 5 months
|
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Cognitive function
Tidsramme: change baseline up to 5 months
|
The battery is composed of 8 games to assess the functioning of attention, visuospatial and visuomotor development, memory system, language, and executive functions in children aged 3 to 9 years.
Test, TENI.
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change baseline up to 5 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Flowmetry
Tidsramme: change baseline up to 5 months
|
Flowmetry will be analyzed using the mean of three measurements recorded with the pediatric Mini wright (400l/m).
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change baseline up to 5 months
|
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Hand grip strength
Tidsramme: change baseline up to 5 months
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Manual grip strength will be assessed three times on the dominant arm using a digital dynamometer (TKK504) fitted to the palm of the schoolchild's hand
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change baseline up to 5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Natalia Bustamante-Ara, PhD, Universidad Autónoma de Chile
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- 01-20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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