En fysisk aktivitetsintervention for at fremme kognitiv sundhed, kardiovaskulær sundhed og søvn hos ældre latinoer
27. april 2026 opdateret af: Gloria Adriana Perez, University of Pennsylvania
Denne undersøgelse er et randomiseret, enkelt-blindt, kontrolleret forsøg, der vil teste en multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health), designet til at fremme fysisk aktivitet med moderat intensitet; teoretisk funderede mediatorer; og sekundære resultater af kardiovaskulær sundhed, søvn og kognitiv funktion.
Deltagerne vil have 4 besøg over en år lang periode.
Dataindsamling vil finde sted ved baseline, 3 måneder, 6 måneder og 12 måneder blandt 216 spanske sprogdominerende latinoer i alderen 55 og ældre med mild kognitiv svækkelse (MCI) [Montreal Cognitive Assessment (MoCA) score 23 til 26 for latinopopulationer].
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
234
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania School of Nursing
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
51 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Kan give informeret samtykke
- 55+ år
- Identificer dig selv som latinamerikansk/latino
- Spansk som hovedsprog
- Villig til at deltage i interventions-/uddannelsessessioner
- Adgang til telefon/mobil
- mindre end 150 min aktivitet/uge (siddende)
- Montreal Cognitive Assessment (MoCA) score (score ≥ 23 til 26 for Latino-populationer)
Ekskluderingskriterier:
- Kan ikke give informeret samtykke
- Mobilitetshandicap
- Muskuloskeletale problem/komorbiditet (forhindrer moderat PA)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Tiempo Juntos Intervention
Hvis de tildeles denne gruppe, vil deltagerne deltage i ugentlige 1-timers gruppesessioner to gange om ugen i 3 måneder.
Sessionerne vil være med en uddannet Community Health Worker, der vil involvere gruppe (5-6 deltagere) moderat intensitetsvandring.
De vil finde sted på fællesskabets partnersteder på tidspunkter, hvor alle deltagere kan deltage.
I tilfælde af dårligt vejr er indendørs steder tilgængelige gennem lokale partnere.
Gåture vil afspejle deltagernes mål og evner, som oprindeligt varer 10 minutter, med 5-minutters stræk-"opvarmnings-" og 5-minutters "cool down"-øvelser, i alt 20 minutter.
Gåturens varighed vil øges med 5 minutter/uge til mindst 30 minutter med programindholdets leveringstid faldende for at imødekomme øgede gåtider inden for den 1-times session.
Efter at have gennemført de 3 måneders fysiske aktivitetssessioner, vil de i de næste 3 måneder modtage motiverende "booster"-sessioner leveret hver anden uge via telefonopkald/sms.
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Hvis de tildeles denne gruppe, vil deltagerne deltage i ugentlige 1-timers gruppesessioner to gange om ugen i 3 måneder.
Sessionerne vil være med en uddannet Community Health Worker, der vil involvere gruppe (5-6 deltagere) moderat intensitetsvandring.
Efter at have gennemført de 3 måneders fysiske aktivitetssessioner, vil de i de næste 3 måneder modtage motiverende "booster"-sessioner leveret hver anden uge via telefonopkald/sms.
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Ingen indgriben: Opmærksomhedskontrol
Hvis de tildeles denne gruppe, vil deltagerne deltage i 1-times gruppesessioner (5-6 deltagere) leveret to gange om ugen i 3 måneder.
Sessionerne vil være med en uddannet Community Health Worker eller kvalificeret personale, der vil involvere gennemgang af uddannelsesemner på spansk relateret til voksnes sundhed.
De vil finde sted på fællesskabets partnersteder eller eksternt på tidspunkter, hvor alle deltagere kan deltage.
I tilfælde af dårligt vejr vil indendørs steder eller fjernvalg være tilgængelige.
Efter at have gennemført de 3 måneders uddannelsessessioner, vil de i de næste 3 måneder modtage pædagogiske "booster"-sessioner leveret hver anden uge via telefonopkald/sms.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændring fra baseline fysisk aktivitetsfrekvens efter 3 måneder
Tidsramme: 12 uger
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Antal aktivitetssessioner
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12 uger
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Ændring fra baseline fysisk aktivitetsfrekvens ved 6 måneder
Tidsramme: 24 uger
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Antal aktivitetssessioner
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24 uger
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Ændring fra baseline fysisk aktivitetsfrekvens ved 12 måneder
Tidsramme: 48 uger
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Antal aktivitetssessioner
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48 uger
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Ændring fra baseline fysisk aktivitetsintensitet efter 3 måneder
Tidsramme: 12 uger
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Let, moderat eller kraftig (bestemt af antal pr. minut)
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12 uger
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Ændring fra baseline fysisk aktivitetsintensitet ved 6 måneder
Tidsramme: 24 uger
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Let, moderat eller kraftig (bestemt af antal pr. minut)
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24 uger
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Ændring fra baseline fysisk aktivitetsintensitet ved 12 måneder
Tidsramme: 48 uger
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Let, moderat eller kraftig (bestemt af antal pr. minut)
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48 uger
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Ændring fra baseline fysisk aktivitetsvarighed ved 3 måneder
Tidsramme: 12 uger
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Samlet tid brugt i aktivitet (timer og minutter)
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12 uger
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Ændring fra baseline fysisk aktivitetsvarighed ved 6 måneder
Tidsramme: 24 uger
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Samlet tid brugt i aktivitet (timer og minutter)
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24 uger
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Ændring fra baseline fysisk aktivitetsvarighed ved 12 måneder
Tidsramme: 48 uger
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Samlet tid brugt i aktivitet (timer og minutter)
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48 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gloria A Perez, PhD, CRNP, University of Pennsylvania
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. august 2021
Primær færdiggørelse (Faktiske)
31. december 2025
Studieafslutning (Faktiske)
31. december 2025
Datoer for studieregistrering
Først indsendt
30. juli 2021
Først indsendt, der opfyldte QC-kriterier
26. august 2021
Først opslået (Faktiske)
1. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 844561
- 1R01AG070351-01 (U.S. NIH-bevilling/kontrakt)
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