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Eine Studie entspricht den Filterkriterien
Kartenansicht
mPATH for Low-income Older Adults
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05935241 ist eine interventionsstudie zur Untersuchung von Sitzzeit, Schlaflosigkeit, Kognitiver Abbau und hat den Status offene rekrutierung. Die Studie startete am 30. Mai 2024 und soll 176 Teilnehmer aufnehmen. Durchgeführt von Johns Hopkins University ist der Abschluss für 31. Dezember 2029 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 11. April 2025 aktualisiert.
Kurzbeschreibung
Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.
Ausführliche Beschreibung
Low-income older adults (LIOA) are a population at higher risk to develop Alzheimer's disease and related dementias (ADRD) and sleep disturbances. Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in LIOA. The growing wearable device and mobile Health (mHealth) provide an innovative approach to deliver individually tailored physical activity interventions at home with flexible schedules to overcome barriers to physical activity in LIOA. In addition, limited research has examined if physical activity interventions impact the individual's Amyloid/Tau/ Neurodegeneration (ATN) Alzheimer's disease biological state and whether physical activity may promote cognition through impacting sleep and AD pathology. This randomized controlled trial is designed to examine the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in LIOA. mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months.
Offizieller Titel
mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults
Erkrankungen
SitzzeitSchlaflosigkeitKognitiver AbbauWeitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2024-05-30
Zuletzt aktualisiert
2025-04-11
Studienende (vorauss.)
2029-12-31
Geplante Rekrutierung
176
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
physical activity
memory
sleep
memory
sleep
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellmPATH mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months | Mpath The active mPATH intervention takes 6 months including (1) The physical activity education session , (2)mHealth learning and practice; (3)Personalized physical activity training, plan, and biweekly phone calls over 24 weeks (4) mHealth strategies to encourage physical activity and facilitate intervention adherence (5) (5) mPATH during 6-12 months: mPATH will be delivered mainly in 24 weeks before the 6-month data collection. During 6-12 months, the participants will have access to study mHealth strategies, and exercise videos. No additional physical activity training by staff will be supported. |
Aktives VergleichspräparatEducation and Social control This attention control group is designed to match the intervention for mPATH's staff-subject interaction duration through monthly home visits in the first 6 months | Aufmerksamkeitskontrolle A registered nurse from the study team will provide 6 monthly home visit (approximately 55-60 minutes each) to provide physical activity education, physical activity safety at home evaluation, feedback, and social activity (meaningful or enjoyable activities as identified by the participants, such as playing cards, doing arts and crafts, listening to music, talking about life history, etc.). |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in episodic memory as assessed by the Cogstate Alzheimer's Battery | Episodic memory will be measured by computerized cognitive batteries using the Cogstate Alzheimer's Battery. | Baseline, 6 months, 12 months |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change in Sleep efficiency as assessed by actigraphy | sleep efficiency will be measured by 7-day actigraph (reported as a percentage). | Baseline, 6 months, 12 months |
Eignungskriterien
Zugelassene Altersgruppen
Ältere Erwachsene
Mindestalter
65 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- self-reported difficulty of sleep
- lack of physical activity/exercise
- low household income
- capacity for moderate intensity exercise
- untreated sleep apnea
- severe depression or anxiety
- dementia
- history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury
- current enrollment in another clinical trial
Zentrale Studienkontakte
Kontakt: Junxin Li, 4105022608, [email protected]
Kontakt: Julianna Kruemmel, 443-692-7169, [email protected]
1 Studienstandorte in 1 Ländern
Maryland
The Johns Hopkins University, School of Nursing, Baltimore, Maryland, 21205, United States
Junxin Li, Kontakt, 410-502-2608
Julianna Kruemmel, Kontakt, 4436927169, [email protected]
Junxin Li, Hauptprüfer
Offene Rekrutierung