NCT05935241

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
May 2024Dec 2029

First Submitted

Initial submission to the registry

June 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

June 29, 2023

Last Update Submit

April 9, 2026

Conditions

Sedentary TimeInsomniaCognitive Decline

Keywords

physical activitymemorysleep

Outcome Measures

Primary Outcomes (1)

  • Change in episodic memory as assessed by the Cogstate

    Episodic memory will be measured by computerized cognitive batteries using Cogstate

    Baseline, 6 months, 12 months

Secondary Outcomes (1)

  • Change in Sleep efficiency as assessed by actigraphy

    Baseline, 6 months, 12 months

Study Arms (2)

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

Behavioral: mPATH

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

Other: Attention Control

Interventions

mPATHBEHAVIORAL

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.

mPATH
Attention ControlOTHER

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.).

Education and Social control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins University, School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorSleep Initiation and Maintenance DisordersCognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Junxin Li

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Youngmin Cho, PhD

    Johns Hopkins University School of Nursing

    STUDY DIRECTOR

Central Study Contacts

Junxin Li

CONTACT

4105022608junxin.li@jhu.edu

Julianna Kruemmel

CONTACT

443-692-7169jkruemm1@jh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

May 30, 2024

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

working on it

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
become available after the primary outcome paper published online
Access Criteria
with request

Locations

US(1)