Een fysieke activiteitsinterventie om cognitieve gezondheid, cardiovasculaire gezondheid en slaap te bevorderen bij oudere Latino's
6 februari 2024 bijgewerkt door: Gloria Adriana Perez, University of Pennsylvania
Deze studie is een gerandomiseerde, enkelblinde, gecontroleerde studie die een interventie op meerdere niveaus zal testen, Tiempo Juntos para la Salud, (Time Together for Health), ontworpen om matige intensiteit fysieke activiteit te bevorderen; theoretisch onderlegde bemiddelaars; en secundaire uitkomsten van cardiovasculaire gezondheid, slaap en cognitieve functie.
Deelnemers krijgen 4 bezoeken over een periode van een jaar.
Gegevensverzameling zal plaatsvinden bij baseline, 3 maanden, 6 maanden en 12 maanden onder 216 Spaanse taal-dominante Latino's van 55 jaar en ouder met Mild Cognitive Impairment (MCI) [Montreal Cognitive Assessment (MoCA) score 23 tot 26 voor Latino-populaties].
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
236
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Gloria A Perez, PhD, CRNP
- Telefoonnummer: 215-746-1840
- E-mail: adrianag@nursing.upenn.edu
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania School of Nursing
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
53 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Kan geïnformeerde toestemming geven
- 55+ jaar
- Identificeer jezelf als Hispanic/Latino
- Spaans als primaire taal
- Bereid om interventie / educatie sessies bij te wonen
- Toegang tot telefoon/gsm
- minder dan 150 min activiteit / week (sedentair)
- Montreal Cognitive Assessment (MoCA)-score (score ≥ 23 tot 26 voor Latino-populaties)
Uitsluitingscriteria:
- Kan geen geïnformeerde toestemming geven
- Mobiliteit handicap
- Musculoskeletaal probleem / co-morbiditeit (voorkomt matige PA)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Tiempo Juntos-interventie
Als ze aan deze groep worden toegewezen, nemen deelnemers gedurende 3 maanden twee keer per week deel aan wekelijkse groepssessies van 1 uur.
De sessies zullen plaatsvinden met een getrainde Community Health Worker waarbij een groep (5-6 deelnemers) met matige intensiteit zal wandelen.
Ze vinden plaats op locaties van gemeenschapspartners op tijden dat alle deelnemers aanwezig kunnen zijn.
Bij slecht weer zijn binnenlocaties beschikbaar via gemeenschapspartners.
De wandelingen weerspiegelen de doelen en capaciteiten van de deelnemer en duren in eerste instantie 10 minuten, met 5 minuten durende "warming-up" en 5 minuten "cooling down"-oefeningen, in totaal 20 minuten.
De duur van de wandeling wordt met 5 minuten per week verhoogd tot ten minste 30 minuten, waarbij de aflevertijd van de programma-inhoud afneemt om de toegenomen wandeltijden binnen de sessie van 1 uur op te vangen.
Na het voltooien van de 3 maanden fysieke activiteitssessies, zullen ze gedurende de volgende 3 maanden om de week motiverende "booster"-sessies ontvangen via telefoongesprekken/sms'jes.
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Als ze aan deze groep worden toegewezen, nemen deelnemers gedurende 3 maanden twee keer per week deel aan wekelijkse groepssessies van 1 uur.
De sessies zullen plaatsvinden met een getrainde Community Health Worker waarbij een groep (5-6 deelnemers) met matige intensiteit zal wandelen.
Na het voltooien van de 3 maanden fysieke activiteitssessies, zullen ze gedurende de volgende 3 maanden om de week motiverende "booster"-sessies ontvangen via telefoongesprekken/sms'jes.
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Geen tussenkomst: Aandachtscontrole
Indien toegewezen aan deze groep, zullen deelnemers deelnemen aan groepssessies van 1 uur (5-6 deelnemers) die gedurende 3 maanden twee keer per week worden gegeven.
De sessies zullen plaatsvinden met een getrainde Community Health Worker of gekwalificeerd personeel, waarbij onderwijsonderwerpen in het Spaans met betrekking tot de gezondheid van volwassenen worden besproken.
Ze vinden plaats op locaties van gemeenschapspartners of op afstand tijdens tijden dat alle deelnemers aanwezig kunnen zijn.
Bij slecht weer zijn binnenlocaties of afgelegen opties beschikbaar.
Na het voltooien van de 3 maanden van educatieve sessies, zullen ze gedurende de volgende 3 maanden educatieve "booster"-sessies ontvangen die om de week worden gegeven via telefoontjes/sms'jes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Verandering van baseline fysieke activiteitsfrequentie na 3 maanden
Tijdsspanne: 12 weken
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Aantal activiteitensessies
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12 weken
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Verandering van baseline fysieke activiteitsfrequentie na 6 maanden
Tijdsspanne: 24 weken
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Aantal activiteitensessies
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24 weken
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Verandering ten opzichte van baseline fysieke activiteitsfrequentie na 12 maanden
Tijdsspanne: 48 weken
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Aantal activiteitensessies
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48 weken
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Verandering van baseline lichamelijke activiteitsintensiteit na 3 maanden
Tijdsspanne: 12 weken
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Licht, matig of krachtig (bepaald door tellingen per minuut)
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12 weken
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Verandering van baseline lichamelijke activiteitsintensiteit na 6 maanden
Tijdsspanne: 24 weken
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Licht, matig of krachtig (bepaald door tellingen per minuut)
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24 weken
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Verandering ten opzichte van baseline lichamelijke activiteitsintensiteit na 12 maanden
Tijdsspanne: 48 weken
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Licht, matig of krachtig (bepaald door tellingen per minuut)
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48 weken
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Verandering van baseline fysieke activiteitsduur na 3 maanden
Tijdsspanne: 12 weken
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Totale tijd besteed aan activiteit (uren en minuten)
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12 weken
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Verandering van baseline fysieke activiteitsduur na 6 maanden
Tijdsspanne: 24 weken
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Totale tijd besteed aan activiteit (uren en minuten)
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24 weken
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Verandering ten opzichte van baseline fysieke activiteitsduur na 12 maanden
Tijdsspanne: 48 weken
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Totale tijd besteed aan activiteit (uren en minuten)
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48 weken
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Gloria A Perez, PhD, CRNP, University of Pennsylvania
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
27 augustus 2021
Primaire voltooiing (Geschat)
31 oktober 2024
Studie voltooiing (Geschat)
31 december 2024
Studieregistratiedata
Eerst ingediend
30 juli 2021
Eerst ingediend dat voldeed aan de QC-criteria
26 augustus 2021
Eerst geplaatst (Werkelijk)
1 september 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
7 februari 2024
Laatste update ingediend die voldeed aan QC-criteria
6 februari 2024
Laatst geverifieerd
1 februari 2024
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 844561
- 1R01AG070351-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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