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临床试验/NCT05935241
NCT05935241招募中不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
176
试验地点
2
主要终点
Change in episodic memory as assessed by the Cogstate Alzheimer's Battery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • untreated sleep apnea
  • severe depression or anxiety
  • history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury
  • current enrollment in another clinical trial

研究组 & 干预措施

mPATH

Experimental

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

干预措施: mPATH (Behavioral)

Education and Social control

Active Comparator

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

干预措施: Attention Control (Other)

结局指标

主要结局

Change in episodic memory as assessed by the Cogstate Alzheimer's Battery

时间窗: Baseline, 6 months, 12 months

Episodic memory will be measured by computerized cognitive batteries using the Cogstate Alzheimer's Battery.

Change in episodic memory as assessed by the Cogstate

时间窗: Baseline, 6 months, 12 months

Episodic memory will be measured by computerized cognitive batteries using Cogstate

次要结局

  • Change in Sleep efficiency as assessed by actigraphy(Baseline, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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