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

NCT06287255 | Active Not Recruiting

• 1 other identifier: 2023H0314
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of EIM+

  The co-primary outcome is to determine the feasibility of utilizing smartwatches among Exercise is Medicine participants aged 65+ as assessed by the number of eligible referrals agreeing to participate in the intervention, program attendance, and completion rates.

  12 months

• Acceptability of EIM+

  The co-primary outcome is to determine the acceptability of utilizing smartwatches among Exercise is Medicine (EIM) participants aged 65+ as assessed by survey responses on perception of wearable devices integrated in to the EIM program and program attendance and completion rates.

  12 months

Secondary Outcomes (25)

• Change in physical activity

  12 months

• Change in weight

  12 months

• Change in BMI

  12 months

• Change in hip circumference

  12 months

• Change in waist circumference

  12 months

Study Arms (1)

Exercise is Medicine Plus

EXPERIMENTAL

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

Behavioral: EIM+

Interventions

EIM+ 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.

Exercise is Medicine Plus

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Related Publications (1)

• 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. 2026 Jan;160:108152. doi: 10.1016/j.cct.2025.108152. Epub 2025 Nov 18.

  PMID: 41265833 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Joseph, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: A single-arm trial

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 1, 2024
• Study Start: March 15, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)