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Clinical Trials/NCT05935241
NCT05935241
Recruiting
Not Applicable

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

Johns Hopkins University2 sites in 1 country176 target enrollmentMay 30, 2024

Overview

Phase
Not Applicable
Intervention
mPATH
Conditions
Sedentary Time
Sponsor
Johns Hopkins University
Enrollment
176
Locations
2
Primary Endpoint
Change in episodic memory as assessed by the Cogstate Alzheimer's Battery
Status
Recruiting
Last Updated
19 days ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2024
End Date
December 31, 2029
Last Updated
19 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

mPATH

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

Intervention: mPATH

Education 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

Intervention: Attention Control

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Baseline, 6 months, 12 months

Episodic memory will be measured by computerized cognitive batteries using Cogstate

Secondary Outcomes

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

Study Sites (2)

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