En fysisk aktivitetsintervention för att främja kognitiv hälsa, kardiovaskulär hälsa och sömn hos äldre latinos
27 april 2026 uppdaterad av: Gloria Adriana Perez, University of Pennsylvania
Denna studie är en randomiserad, enkelblind, kontrollerad studie som kommer att testa en intervention på flera nivåer, Tiempo Juntos para la Salud, (Time Together for Health) utformad för att främja fysisk aktivitet med måttlig intensitet; teoretiskt grundade medlare; och sekundära resultat av kardiovaskulär hälsa, sömn och kognitiv funktion.
Deltagarna kommer att ha 4 besök under en år lång period.
Datainsamling kommer att ske vid baslinjen, 3 månader, 6 månader och 12 månader bland 216 spanska språkdominerande latinos i åldern 55 och äldre med mild kognitiv funktionsnedsättning (MCI) [Montreal Cognitive Assessment (MoCA) poäng 23 till 26 för latinopopulationer].
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
234
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania School of Nursing
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
51 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Kan ge informerat samtycke
- 55+ år
- Identifiera dig själv som latinamerikansk/latino
- Spanska som huvudspråk
- Villig att delta i interventions-/utbildningstillfällen
- Tillgång till telefon/cell
- mindre än 150 min aktivitet/vecka (sittande)
- Montreal Cognitive Assessment (MoCA) poäng (poäng ≥ 23 till 26 för Latino-populationer)
Exklusions kriterier:
- Kan inte ge informerat samtycke
- Rörelsehandikapp
- Muskuloskeletala problem/komorbiditet (förhindrar måttlig PA)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Tiempo Juntos Intervention
Om de tilldelas den här gruppen kommer deltagarna att delta i veckovisa 1-timmes gruppsessioner två gånger i veckan under 3 månader.
Sessionerna kommer att vara med en utbildad hälsoarbetare som kommer att involvera grupppromenader (5-6 deltagare) med måttlig intensitet.
De kommer att äga rum på communitypartners webbplatser under tider då alla deltagare kan delta.
Vid ogynnsamt väder finns inomhusplatser tillgängliga via community-partners.
Promenader kommer att spegla deltagarnas mål och förmågor, som initialt varar i 10 minuter, med 5 minuters stretching "uppvärmning" och 5 minuters "cool down" övningar, i totalt 20 minuter.
Promenadens längd kommer att öka med 5 minuter/vecka till minst 30 minuter med programinnehållets leveranstid som minskar för att tillgodose ökade promenadtider inom 1-timmespasset.
Efter att ha slutfört de 3 månaderna med fysisk aktivitetssessioner, under de kommande 3 månaderna, kommer de att få motiverande "booster"-sessioner levererade varannan vecka via telefonsamtal/sms.
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Om de tilldelas den här gruppen kommer deltagarna att delta i veckovisa 1-timmes gruppsessioner två gånger i veckan under 3 månader.
Sessionerna kommer att vara med en utbildad hälsoarbetare som kommer att involvera grupppromenader (5-6 deltagare) med måttlig intensitet.
Efter att ha slutfört de 3 månaderna med fysisk aktivitetssessioner, under de kommande 3 månaderna, kommer de att få motiverande "booster"-sessioner levererade varannan vecka via telefonsamtal/sms.
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Inget ingripande: Uppmärksamhetskontroll
Om de tilldelas den här gruppen kommer deltagarna att delta i 1-timmes gruppsessioner (5-6 deltagare) som levereras två gånger i veckan under 3 månader.
Sessionerna kommer att vara med en utbildad hälsovårdsarbetare eller kvalificerad personal som kommer att involvera genomgång av utbildningsämnen på spanska relaterade till vuxnas hälsa.
De kommer att äga rum på communitypartners webbplatser eller på distans under tider då alla deltagare kan delta.
Vid ogynnsamt väder kommer inomhusplatser eller avlägsna alternativ att vara tillgängliga.
Efter att ha avslutat de 3 månadernas utbildningssessioner, under de kommande 3 månaderna, kommer de att få pedagogiska "booster"-sessioner levererade varannan vecka via telefonsamtal/sms.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Ändring från baslinjen för fysisk aktivitetsfrekvens vid 3 månader
Tidsram: 12 veckor
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Antal aktivitetspass
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12 veckor
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Ändring från baslinjen för fysisk aktivitetsfrekvens vid 6 månader
Tidsram: 24 veckor
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Antal aktivitetspass
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24 veckor
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Ändring från baslinjen för fysisk aktivitetsfrekvens vid 12 månader
Tidsram: 48 veckor
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Antal aktivitetspass
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48 veckor
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Ändring från baslinjen för fysisk aktivitetsintensitet vid 3 månader
Tidsram: 12 veckor
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Lätt, måttlig eller kraftig (bestäms av antal per minut)
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12 veckor
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Ändring från baslinjen för fysisk aktivitetsintensitet vid 6 månader
Tidsram: 24 veckor
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Lätt, måttlig eller kraftig (bestäms av antal per minut)
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24 veckor
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Ändring från baslinjen för fysisk aktivitetsintensitet vid 12 månader
Tidsram: 48 veckor
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Lätt, måttlig eller kraftig (bestäms av antal per minut)
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48 veckor
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Ändring från Baseline Fysisk aktivitet Varaktighet vid 3 månader
Tidsram: 12 veckor
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Total tid i aktivitet (timmar och minuter)
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12 veckor
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Ändring från baslinjen för fysisk aktivitetslängd vid 6 månader
Tidsram: 24 veckor
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Total tid i aktivitet (timmar och minuter)
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24 veckor
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Ändring från baslinjen för fysisk aktivitetslängd vid 12 månader
Tidsram: 48 veckor
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Total tid i aktivitet (timmar och minuter)
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48 veckor
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Gloria A Perez, PhD, CRNP, University of Pennsylvania
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studiestart (Faktisk)
27 augusti 2021
Primärt slutförande (Faktisk)
31 december 2025
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31 december 2025
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Först inskickad
30 juli 2021
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2021
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1 september 2021
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Senaste uppdatering publicerad (Faktisk)
1 maj 2026
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27 april 2026
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1 april 2026
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Andra studie-ID-nummer
- 844561
- 1R01AG070351-01 (U.S.S. NIH-anslag/kontrakt)
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