mPATH for Low-income Older Adults

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935241
• Other study ID #: IRB00396390
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2024
• Est. completion date: December 1, 2029

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Junxin Li
• Phone: 4105022608
• Email: junxin.li[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Insomnia
• Sedentary Time

Intervention

Behavioral:
• 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 strategies, and exercise videos. No additional physical activity training by staff will be supported.

Other:
• 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.).

Locations

Country	Name	City	State
United States	The Johns Hopkins University, School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in episodic memory as assessed by the Cogstate Alzheimer's Battery	Episodic memory will be measured by computerized cognitive batteries using the Cogstate Alzheimer's Battery.	Baseline, 6 months, 12 months
Secondary	Change in Sleep efficiency as assessed by actigraphy	sleep efficiency will be measured by 7-day actigraph (reported as a percentage).	Baseline, 6 months, 12 months