Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals
- Conditions
- ObesityPhysical Inactivity
- Interventions
- Behavioral: EIM+
- Registration Number
- NCT06287255
- Lead Sponsor
- Ohio State University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Age 65+
- No healthcare provider-imposed limitations on physical activity
- English-speaking
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise is Medicine Plus EIM+ Participants receiving the Exercise is Medicine program along with a smartwatch.
- Primary Outcome Measures
Name Time Method Acceptability of EIM+ 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.
Feasibility of EIM+ 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.
- Secondary Outcome Measures
Name Time Method Change in diet 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.
Change in daily steps total 12 months The secondary outcome is daily steps taken before, during and after program completion as assessed by smartwatch tracking.
Change in minutes of vigorous activity 12 months The secondary outcome is minutes of vigorous activity before, during and after program completion as assessed by smartwatch tracking.
Change in minutes of moderate activity 12 months The secondary outcome is minutes of moderate activity before, during and after program completion as assessed by smartwatch tracking.
Change in hip circumference 12 months The secondary outcome is hip circumference before, during and after program completion
Change in waist circumference 12 months The secondary outcome is waist circumference before, during and after program completion
Change in blood pressure 12 months The secondary outcome is blood pressure before, during and after program completion
Change in heart rate variability 12 months The secondary outcome is heart rate variability before, during and after program completion
Change in hemoglobin A1c 12 months The secondary outcome is hemoglobin A1c before, during and after program completion
Change in perceived stress 12 months The secondary outcome is perceived stress before, during and after program completion as assessed by responses to the Perceived Stress Scale assessment.
Change in activity minutes per week 12 months The secondary outcome is activity minutes per week before, during and after program completion as assessed by smartwatch tracking.
Change in sleep quality 12 months The secondary outcome is sleep quality before, during and after program completion as assessed by smartwatch tracking.
Change in distance moved 12 months The secondary outcome is distance moved before, during and after program completion as assessed by smartwatch tracking.
Change in minutes of light activity 12 months The secondary outcome is minutes of light activity before, during and after program completion as assessed by smartwatch tracking.
Change in weight 12 months The secondary outcome is weight before, during and after program completion
Change in estimated energy expenditure 12 months The secondary outcome is estimated energy expenditure before, during and after program completion as assessed by smartwatch tracking.
Change in physical activity 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).
Change in BMI 12 months The secondary outcome is BMI before, during and after program completion
Change in measured steps per minute 12 months The secondary outcome is measured steps per minute before, during and after program completion as assessed by smartwatch tracking.
Change in sleep duration 12 months The secondary outcome is sleep duration before, during and after program completion as assessed by smartwatch tracking.
Change in heart rate 12 months The secondary outcome is heart rate before, during and after program completion as assessed by smartwatch tracking.
Change in depressive symptoms 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)
Change in minutes of sedentary time 12 months The secondary outcome is minutes of sedentary time before, during and after program completion as assessed by smartwatch tracking.
Change in number of manually entered and automatically detected physical activities (walking, running, etc.) 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.
Change in quality of life measures 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.
Trial Locations
- Locations (1)
The Ohio State University
🇺🇸Columbus, Ohio, United States