Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05935241

Conditions

Sedentary Time

Insomnia

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

mPATH

Attention Control

Study Details

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.

Conditions

Sedentary Time

Insomnia

Cognitive Decline

Study ID

NCT05935241

Start date

May 30, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: 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

Interventions

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.

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.).

Primary outcome measure

  • Change in episodic memory as assessed by the Cogstate [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Junxin Li

4105022608junxin.li@jhu.edu

Julianna Kruemmel

443-692-7169jkruemm1@jh.edu

Locations

The Johns Hopkins University, School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Junxin Li

410-502-2608

Julianna Kruemmel

4436927169jkruemm1@jh.edu

Principal Investigator:

Junxin Li

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • physical activity
  • memory
  • sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.