Just In Time Intervention to Enhance Physical Activity Among Stroke Survivors

Automated Coping Interventions to Enhance Physical Activity Among Stroke Survivors

A 3-month single-arm pilot trial to evaluate the feasibility of an automated and individualized coping intervention among stroke survivors.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Device: Google-Pixel Watch 3; Behavioral: Exercise prompts

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult Patients Diagnosed with Stroke: Participants must be adults (age ≥ 18) who have been clinically diagnosed with a stroke between 3 months and 3 years.
2. Community-Dwelling: Participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals.
3. Independently Mobile: Participants must be able to walk without any aid or assistance, corresponding to a modified Rankin Scale (mRS) score of 0-2.
4. Physically Inactive: Participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (MVPA) in the past week.
5. Internet Access: Participants must have access to the Internet for at least a few hours every day.
6. Medically Cleared to participate: Before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study.

Exclusion Criteria:

1. Participating in Another Research Project Involving Physical Activity: To avoid potential confounding variables that could affect the study's outcomes.
2. Planning to Move or Have Surgery in the Next 6 Months: Participants who plan to move or undergo surgery within the next six months may face disruptions that could affect their ability to complete the study.
3. Cognitive Impairment: Cognitive impairment can affect a participant's ability to understand and follow study protocols, which is crucial for informed consent and reliable data collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Adult stroke Survivors; This arm consists of stroke survivors with specified inclusion/exclusion criteria who will receive goal reminders and motivational, in addition to coping messages through Google Pixel Watches.

Device: Google-Pixel Watch 3; The participant will wear Google-Pixel Watch 3 for at least 10 hours during the 3-month intervention and will receive goal reminders and motivational and coping messages through those watches. At baseline and after 3-months intervention, demographics (standard questionnaire pertaining to subjects' age, sex, race, education and income), technology literacy (eHealth Literacy Scale pertaining to subjects' ability to perform a number of tasks such as turning on the device, using internet and communication), and wearables affinity (pertains to how the subject currently uses wearable in their daily living tasks) will be measured.; Behavioral: Exercise prompts; The participants will receive goal reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants retained	The number of participants who remain in the study until its conclusion.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects recruited for the study	This measures how effectively participants are being enrolled in the study.	3 months
Number of hours devices were worn	Number of hours device were worn by the subjects.	3 months
Number of prompts	This refers to the number of prompts responded by participants throughout the study duration.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly Goal Adherence	Number of weekly physical activity goals met by the participants throughout the study.	3 months
Minutes of Physical Activity	The total time spent in light, moderate and vigorous physical activity during the study period. Light, moderate and vigorous physical activity are defined based on subjects' maximal heart rate. Maximal Heart Rate (MHR) = 220 - subject's age. Light is defined as 30-50% of MHR, moderate intensity as 50-75% of MHR and vigorous intensity as 70-85% of MHR according to American Heart Association. For instance, a 50-year-old subject's maximum heart rate would be 220 - 50 = 170. For the subject to be doing moderate intensity, their heart rate should be in between 85-127 and 119-144 to perform vigorous physical activity.	3 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Stroke; Smart Phone; Wearable tracker
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Stroke; Motor Activity
• Other Study ID Numbers: STUDY00025868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No