Obesity, Physical Inactivity
Conditions
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.
Interventions
BEHAVIORALEIM+
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.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single-arm trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 weight | 12 months | The secondary outcome is weight before, during and after program completion |
| Change in BMI | 12 months | The secondary outcome is BMI before, during and after program completion |
| 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 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 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 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 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 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 quality | 12 months | The secondary outcome is sleep quality 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 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 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 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. |
| 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 heart rate | 12 months | The secondary outcome is heart rate before, during and after program completion as assessed by smartwatch tracking. |
Countries
United States
Outcome results
None listed