Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Acceptability of EIM+
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No healthcare provider-imposed limitations on physical activity
- •English-speaking
排除标准
- •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.
结局指标
主要结局
Acceptability of EIM+
时间窗: 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+
时间窗: 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.
次要结局
- Change in diet(12 months)
- Change in daily steps total(12 months)
- Change in minutes of vigorous activity(12 months)
- Change in minutes of moderate activity(12 months)
- Change in hip circumference(12 months)
- Change in waist circumference(12 months)
- Change in blood pressure(12 months)
- Change in heart rate variability(12 months)
- Change in hemoglobin A1c(12 months)
- Change in perceived stress(12 months)
- Change in activity minutes per week(12 months)
- Change in sleep quality(12 months)
- Change in distance moved(12 months)
- Change in minutes of light activity(12 months)
- Change in weight(12 months)
- Change in estimated energy expenditure(12 months)
- Change in physical activity(12 months)
- Change in BMI(12 months)
- Change in measured steps per minute(12 months)
- Change in sleep duration(12 months)
- Change in heart rate(12 months)
- Change in depressive symptoms(12 months)
- Change in minutes of sedentary time(12 months)
- Change in number of manually entered and automatically detected physical activities (walking, running, etc.)(12 months)
- Change in quality of life measures(12 months)
研究者
Joshua Joseph, MD
Associate Professor of Internal Medicine
Ohio State University