Clinical trial NCT06287255: Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals
Official title: Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm trial
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Feasibility of EIM+
timeFrame: 12 months
measure: Acceptability of EIM+
timeFrame: 12 months
Secondary outcomes:
measure: Change in physical activity
timeFrame: 12 months
measure: Change in weight
timeFrame: 12 months
measure: Change in BMI
timeFrame: 12 months
measure: Change in hip circumference
timeFrame: 12 months
measure: Change in waist circumference
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: 12 months
measure: Change in heart rate variability
timeFrame: 12 months
measure: Change in hemoglobin A1c
timeFrame: 12 months
measure: Change in perceived stress
timeFrame: 12 months
measure: Change in depressive symptoms
timeFrame: 12 months
measure: Change in diet
timeFrame: 12 months
measure: Change in activity minutes per week
timeFrame: 12 months
measure: Change in daily steps total
timeFrame: 12 months
measure: Change in measured steps per minute
timeFrame: 12 months
measure: Change in sleep quality
timeFrame: 12 months
measure: Change in sleep duration
timeFrame: 12 months
measure: Change in estimated energy expenditure
timeFrame: 12 months
measure: Change in heart rate
timeFrame: 12 months
measure: Change in distance moved
timeFrame: 12 months
measure: Change in minutes of vigorous activity
timeFrame: 12 months
measure: Change in minutes of moderate activity
timeFrame: 12 months
measure: Change in minutes of light activity
timeFrame: 12 months
measure: Change in minutes of sedentary time
timeFrame: 12 months
measure: Change in number of manually entered and automatically detected physical activities (walking, running, etc.)
timeFrame: 12 months
measure: Change in quality of life measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: