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NCT Number: NCT06287255

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Physical Inactivity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of EIM+

    Time frame: 12 months

    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.

  2. Acceptability of EIM+

    Time frame: 12 months

    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.

Secondary outcomes

  1. Change in physical activity

    Time frame: 12 months

    The secondary outcome of physical activity levels before, during and after program completion (preliminary efficacy) will be examined both continuously (moderate-vigorous physical activity minutes per week) and categorically (meeting the goal of 150 minutes of moderate-vigorous physical activity per week).

  2. Change in weight

    Time frame: 12 months

    The secondary outcome is weight before, during and after program completion

  3. Change in BMI

    Time frame: 12 months

    The secondary outcome is BMI before, during and after program completion

  4. Change in hip circumference

    Time frame: 12 months

    The secondary outcome is hip circumference before, during and after program completion

  5. Change in waist circumference

    Time frame: 12 months

    The secondary outcome is waist circumference before, during and after program completion

  6. Change in blood pressure

    Time frame: 12 months

    The secondary outcome is blood pressure before, during and after program completion

  7. Change in heart rate variability

    Time frame: 12 months

    The secondary outcome is heart rate variability before, during and after program completion

  8. Change in hemoglobin A1c

    Time frame: 12 months

    The secondary outcome is hemoglobin A1c before, during and after program completion

  9. Change in perceived stress

    Time frame: 12 months

    The secondary outcome is perceived stress before, during and after program completion as assessed by responses to the Perceived Stress Scale assessment.

  10. Change in depressive symptoms

    Time frame: 12 months

    The secondary outcome is depressive symptoms before, during and after program completion as assessed by responses to the Patient Health Questionnaire-9 (PHQ-9)

  11. Change in diet

    Time frame: 12 months

    The secondary outcome is diet before, during and after program completion as assessed by responses to the Mediterranean Eating Pattern for Americans diet adherence screener.

  12. Change in activity minutes per week

    Time frame: 12 months

    The secondary outcome is activity minutes per week before, during and after program completion as assessed by smartwatch tracking.

  13. Change in daily steps total

    Time frame: 12 months

    The secondary outcome is daily steps taken before, during and after program completion as assessed by smartwatch tracking.

  14. Change in measured steps per minute

    Time frame: 12 months

    The secondary outcome is measured steps per minute before, during and after program completion as assessed by smartwatch tracking.

  15. Change in sleep quality

    Time frame: 12 months

    The secondary outcome is sleep quality before, during and after program completion as assessed by smartwatch tracking.

  16. Change in sleep duration

    Time frame: 12 months

    The secondary outcome is sleep duration before, during and after program completion as assessed by smartwatch tracking.

  17. Change in estimated energy expenditure

    Time frame: 12 months

    The secondary outcome is estimated energy expenditure before, during and after program completion as assessed by smartwatch tracking.

  18. Change in heart rate

    Time frame: 12 months

    The secondary outcome is heart rate before, during and after program completion as assessed by smartwatch tracking.

  19. Change in distance moved

    Time frame: 12 months

    The secondary outcome is distance moved before, during and after program completion as assessed by smartwatch tracking.

  20. Change in minutes of vigorous activity

    Time frame: 12 months

    The secondary outcome is minutes of vigorous activity before, during and after program completion as assessed by smartwatch tracking.

  21. Change in minutes of moderate activity

    Time frame: 12 months

    The secondary outcome is minutes of moderate activity before, during and after program completion as assessed by smartwatch tracking.

  22. Change in minutes of light activity

    Time frame: 12 months

    The secondary outcome is minutes of light activity before, during and after program completion as assessed by smartwatch tracking.

  23. Change in minutes of sedentary time

    Time frame: 12 months

    The secondary outcome is minutes of sedentary time before, during and after program completion as assessed by smartwatch tracking.

  24. Change in number of manually entered and automatically detected physical activities (walking, running, etc.)

    Time frame: 12 months

    The secondary outcome is manually entered and automatically detected physical activities (walking, running, etc.) before, during and after program completion as assessed by smartwatch tracking.

  25. Change in quality of life measures

    Time frame: 12 months

    The secondary outcome is quality of life measures before, during and after program completion as assessed by responses to the RAND Short Form (RAND-SF 36) v1.0 survey.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)

Acronym: EIM+

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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