Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals

NCT ID: NCT06287255

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-05-01

Brief Summary

The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.

The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.

The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.

Conditions

Physical Inactivity; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise is Medicine Plus

Participants receiving the Exercise is Medicine program along with a smartwatch.

Group Type: EXPERIMENTAL

EIM+

Intervention Type: BEHAVIORAL

The Exercise is Medicine (EIM) program involves a personalized exercise prescription and wellness coaching component. At the first 1:1 session, participants are provided with a Fitbit and onboarded with Fitabase, allowing for documentation of baseline health behaviors. Over the course of the program, the EIM fitness specialist reviews Fitbit data and progress towards goals, sending push notifications for encouragement and reminders. A personal training session is conducted, followed by sixteen group sessions including up to eight participants. The final session includes updating goals, incorporating Fitbits, and providing an updated exercise prescription. Upon program completion, participants will attend monthly webinars and health coaching sessions at 6- and 12-months post-program. The program aims to help individuals overcome barriers and maintain long-term exercise self-efficacy.

Interventions

EIM+

The Exercise is Medicine (EIM) program involves a personalized exercise prescription and wellness coaching component. At the first 1:1 session, participants are provided with a Fitbit and onboarded with Fitabase, allowing for documentation of baseline health behaviors. Over the course of the program, the EIM fitness specialist reviews Fitbit data and progress towards goals, sending push notifications for encouragement and reminders. A personal training session is conducted, followed by sixteen group sessions including up to eight participants. The final session includes updating goals, incorporating Fitbits, and providing an updated exercise prescription. Upon program completion, participants will attend monthly webinars and health coaching sessions at 6- and 12-months post-program. The program aims to help individuals overcome barriers and maintain long-term exercise self-efficacy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 65+
• No healthcare provider-imposed limitations on physical activity
• English-speaking

Exclusion Criteria

• Symptoms suggestive of coronary artery disease (CAD) or congestive heart failure (CHF) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion)
• Myocardial infarction within the last 12 months
• Revascularization within the last 12 months
• Stroke/transient ischemic attack (TIA) within the past 12 months
• Unstable angina
• Congestive heart failure (New York Heart Association (NYHA) Class II, III or IV)
• Ventricular arrhythmia
• Clinically significant cardiac valve disease
• Blood pressure >160/100 mmHg
• Uncontrolled seizure disorder
• Major surgery within the past three months
• Severe or frequent hypoglycemia
• Inability to independently manage blood glucose during activity
• Severe autonomic or peripheral neuropathy
• Active foot ulcers
• Unstable retinopathy.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Joseph, MD

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Hauben J, Luthy J, Nafiu T, Brengartner A, Omar M, Nemati D, Zhao S, Brock G, Urse K, Paro J, Joseph JJ. Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals. Contemp Clin Trials. 2025 Nov 18:108152. doi: 10.1016/j.cct.2025.108152. Online ahead of print.

Reference Type: DERIVED

PMID: 41265833 (View on PubMed)

Other Identifiers

2023H0314

Identifier Type: -

Identifier Source: org_study_id