Меню
Идёт набор NCT05935241

mPATH for Low-income Older Adults

Без фазы С лечением Sedentary Time Insomnia Cognitive Decline

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mPATH, Attention Control.
Кому может быть актуально
Состояния в реестре: Sedentary Time, Insomnia, Cognitive Decline. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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
  • Другое Attention Control
    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.).

Первичные конечные точки

  • Change in episodic memory as assessed by the Cogstate [Срок оценки: Baseline, 6 months, 12 months]
Вторичные конечные точки (1)
  • Change in Sleep efficiency as assessed by actigraphy [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

  • self-reported difficulty of sleep
  • lack of physical activity/exercise
  • low household income
  • capacity for moderate intensity exercise

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • The Johns Hopkins University, School of Nursing — Baltimore

Идентификаторы

NCT: NCT05935241 · IRB00396390 · 1R01AG080613-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗