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Идёт набор NCT04906759

Meal Delivery and Exercise

Без фазы С лечением Frailty

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: Meals plus exercise, Meals only.
Кому может быть актуально
Состояния в реестре: Frailty. Базовые параметры: от 60 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 →

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Официальное название

A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults

Обзор

The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.

Вмешательства

  • Поведенческое Meals plus exercise
    Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound
  • Поведенческое Meals only
    Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will h

Первичные конечные точки

  • Change in gait speed [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in measure of HSP70 (ng/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in Measure of MIP-1β (pg/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in Measure of sIL-6R (pg/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
Вторичные конечные точки (12)
  • Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in grip strength [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in daily average steps from the activity tracker [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Number of patients that required emergency room visits [Срок оценки: 6 months post baseline visit]
  • Number of patients that required hospitalization [Срок оценки: 6 months post baseline visit]
  • Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.) [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in loneliness as assessed by the UCLA Loneliness Scale (ULS) [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18) [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • change in measure of IL-6 (pg/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in measures of CRP (ng/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]
  • Change in measures of TNF-α (pg/mL) expression [Срок оценки: 4 weeks,8 weeks,12 weeks from baseline]

Критерии участия

Критерии включения

  • homebound (normally unable to leave the home unassisted)
  • frail or prefrail by The Fried Frailty Phenotype (FFP)
  • medically stable

Критерии исключения

  • robust by FFP
  • have Mini-Cog score <3 and/or are unable to follow instructions
  • have a pre-diagnosed terminal illness
  • unable to ambulate
  • unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT04906759 · HSC-MS-21-0125 · 1K23AG072042-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗