Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Heart Rate Monitor Accuracy Compared to ECG
研究概览
简要总结
The objective of this study is to evaluate the accuracy of four heart rate monitors in cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving exercise on a treadmill and/or stationary bicycle.
详细描述
This study will assess the accuracy of four of the best-selling optical heart rate monitors when worn by cardiac rehabilitation patients.
During testing, each subject will wear:
- Two different optical heart rate monitors (one on each wrist)
- A Polar chest-strap based monitor
- ECG leads
The types of wrist-worn heart rate monitors assigned to each subject will be randomly assigned.
The location (left or right wrist) will also be randomly assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus
排除标准
- •Presence of a cardiac pacemaker
- •Known chronic and persistent heart rhythm disorders
- •Tattoos around the wrist or forearm area
- •Use of a radial artery graft for coronary artery bypass grafting
研究组 & 干预措施
Apple Watch
Apple Watch Heart Rate Monitoring Device
干预措施: Fit Bit Blaze (Device)
Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device
干预措施: Garmin Forerunner 235 (Device)
Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device
干预措施: Tom Tom Spark Cardio (Device)
Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device
干预措施: Apple Watch (Device)
Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device
干预措施: Fit Bit Blaze (Device)
Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device
干预措施: Garmin Forerunner 235 (Device)
Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device
干预措施: Tom Tom Spark Cardio (Device)
Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device
干预措施: Apple Watch (Device)
Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device
干预措施: Fit Bit Blaze (Device)
Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device
干预措施: Garmin Forerunner 235 (Device)
Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device
干预措施: Tom Tom Spark Cardio (Device)
Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device
干预措施: Apple Watch (Device)
Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device
干预措施: Fit Bit Blaze (Device)
Apple Watch
Apple Watch Heart Rate Monitoring Device
干预措施: Garmin Forerunner 235 (Device)
Apple Watch
Apple Watch Heart Rate Monitoring Device
干预措施: Tom Tom Spark Cardio (Device)
Apple Watch
Apple Watch Heart Rate Monitoring Device
干预措施: Apple Watch (Device)
结局指标
主要结局
Heart Rate Monitor Accuracy Compared to ECG
时间窗: 16 minutes
The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient.
次要结局
未报告次要终点
研究者
Marc Gillinov, MD
Principal Investigator
The Cleveland Clinic