Clinical trial NCT05935241: mPATH for Low-income Older Adults
Official title: mHealth-Facilitated Physical Activity Toward Health (mPATH) Intervention for Low-Income Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Time
Insomnia
Cognitive Decline
Keywords: physical activity
memory
sleep
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-07-07
Enrollment: 176
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* dementia
* history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury
* current enrollment in another clinical trial

Primary outcomes:
measure: Change in episodic memory as assessed by the Cogstate Alzheimer's Battery
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in Sleep efficiency as assessed by actigraphy
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University, School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Junxin Li
role: PRINCIPAL_INVESTIGATOR
References: