En fysisk aktivitetsintervensjon for å fremme kognitiv helse, kardiovaskulær helse og søvn hos eldre latinoer
27. april 2026 oppdatert av: Gloria Adriana Perez, University of Pennsylvania
Denne studien er en randomisert, enkeltblind, kontrollert studie som vil teste en intervensjon på flere nivåer, Tiempo Juntos para la Salud, (Time Together for Health) designet for å fremme fysisk aktivitet med moderat intensitet; teoretisk funderte mediatorer; og sekundære utfall av kardiovaskulær helse, søvn og kognitiv funksjon.
Deltakerne vil ha 4 besøk over en år lang periode.
Datainnsamling vil finne sted ved baseline, 3 måneder, 6 måneder og 12 måneder blant 216 spanskspråklige latinoer i alderen 55 og eldre med mild kognitiv svikt (MCI) [Montreal Cognitive Assessment (MoCA) score 23 til 26 for latinopopulasjoner].
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
234
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania School of Nursing
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
51 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Kan gi informert samtykke
- 55+ år
- Identifiser deg selv som latinamerikansk/latino
- Spansk som hovedspråk
- Villig til å delta på intervensjons-/utdanningsmøter
- Tilgang til telefon/mobil
- mindre enn 150 minutter med aktivitet / uke (sittende)
- Montreal Cognitive Assessment (MoCA) poengsum (score ≥ 23 til 26 for Latino-populasjoner)
Ekskluderingskriterier:
- Kan ikke gi informert samtykke
- Mobilitetshemming
- Muskel- og skjelettproblem/komorbiditet (forhindrer moderat PA)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Tiempo Juntos Intervention
Hvis de blir tildelt denne gruppen, vil deltakerne delta i ukentlige 1-timers gruppeøkter to ganger i uken i 3 måneder.
Øktene vil være med en utdannet helsearbeider som vil involvere gruppe (5-6 deltakere) moderat intensitets gange.
De vil finne sted på fellesskapspartnernettsteder når alle deltakere kan delta.
I tilfelle ugunstig vær er innendørsplasser tilgjengelig gjennom fellesskapspartnere.
Turer vil gjenspeile deltakernes mål og evner, som i utgangspunktet varer i 10 minutter, med 5-minutters tøynings-"oppvarming" og 5-minutters "avkjølingsøvelser", i totalt 20 minutter.
Turvarigheten vil øke med 5 minutter/uke til minst 30 minutter med programinnhold som reduseres for å imøtekomme økte gange i løpet av 1-times økten.
Etter å ha fullført de 3 månedene med fysisk aktivitetsøkter, vil de de neste 3 månedene motta motiverende «booster» økter levert annenhver uke via telefonsamtaler/tekstmeldinger.
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Hvis de blir tildelt denne gruppen, vil deltakerne delta i ukentlige 1-timers gruppeøkter to ganger i uken i 3 måneder.
Øktene vil være med en utdannet helsearbeider som vil involvere gruppe (5-6 deltakere) moderat intensitets gange.
Etter å ha fullført de 3 månedene med fysisk aktivitetsøkter, vil de de neste 3 månedene motta motiverende «booster» økter levert annenhver uke via telefonsamtaler/tekstmeldinger.
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Ingen inngripen: Oppmerksomhetskontroll
Hvis de blir tildelt denne gruppen, vil deltakerne delta i 1-times gruppeøkter (5-6 deltakere) levert to ganger i uken i 3 måneder.
Øktene vil være med en utdannet helsearbeider eller kvalifisert personell som vil involvere gjennomgang av opplæringsemner på spansk relatert til voksenhelse.
De vil finne sted på fellesskapspartnernettsteder eller eksternt når alle deltakere kan delta.
I tilfelle dårlig vær vil innendørs steder eller eksterne alternativer være tilgjengelige.
Etter å ha fullført de 3 månedene med opplæringsøkter, vil de de neste 3 månedene motta pedagogiske «booster»-økter levert annenhver uke via telefonsamtaler/tekstmeldinger.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Endring fra baseline fysisk aktivitetsfrekvens ved 3 måneder
Tidsramme: 12 uker
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Antall aktivitetsøkter
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12 uker
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Endring fra baseline fysisk aktivitetsfrekvens ved 6 måneder
Tidsramme: 24 uker
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Antall aktivitetsøkter
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24 uker
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Endring fra baseline fysisk aktivitetsfrekvens ved 12 måneder
Tidsramme: 48 uker
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Antall aktivitetsøkter
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48 uker
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Endring fra baseline fysisk aktivitetsintensitet ved 3 måneder
Tidsramme: 12 uker
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Lett, moderat eller kraftig (bestemt av antall per minutt)
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12 uker
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Endring fra baseline fysisk aktivitetsintensitet ved 6 måneder
Tidsramme: 24 uker
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Lett, moderat eller kraftig (bestemt av antall per minutt)
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24 uker
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Endring fra baseline fysisk aktivitetsintensitet ved 12 måneder
Tidsramme: 48 uker
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Lett, moderat eller kraftig (bestemt av antall per minutt)
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48 uker
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Endring fra baseline fysisk aktivitetsvarighet ved 3 måneder
Tidsramme: 12 uker
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Total tid brukt i aktivitet (timer og minutter)
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12 uker
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Endring fra baseline fysisk aktivitetsvarighet ved 6 måneder
Tidsramme: 24 uker
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Total tid brukt i aktivitet (timer og minutter)
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24 uker
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Endring fra baseline fysisk aktivitetsvarighet ved 12 måneder
Tidsramme: 48 uker
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Total tid brukt i aktivitet (timer og minutter)
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48 uker
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gloria A Perez, PhD, CRNP, University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. august 2021
Primær fullføring (Faktiske)
31. desember 2025
Studiet fullført (Faktiske)
31. desember 2025
Datoer for studieregistrering
Først innsendt
30. juli 2021
Først innsendt som oppfylte QC-kriteriene
26. august 2021
Først lagt ut (Faktiske)
1. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 844561
- 1R01AG070351-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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