Accuracy of Commercially Available Heart Rate Monitors III

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Heart rate will be assessed using each of the 4 monitors with the subject on the exercise machines under each of the following conditions: Pre-exercise Treadmill: at 3, 5 and 7 min. Stationary Cycle: at 3, 5 and 7 min.

Official Title
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Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Device: Fit Bit Blaze
* Device: Garmin Forerunner 235
* Device: Tom Tom Spark Cardio
* Device: Apple Watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fit Bit Blaze<br>Fit Bit Blaze Heart Rate Monitoring Device | Device: Fit Bit Blaze<br>* Fit Bit Blaze Heart Rate Monitoring Device<br>Device: Garmin Forerunner 235<br>* Garmin Forerunner 235 Heart Rate Monitoring Device<br>Device: Tom Tom Spark Cardio<br>* Tom Tom Spark Cardio Heart Rate Monitoring Device<br>Device: Apple Watch<br>* Apple Watch Heart Rate Monitoring Device<br>|
| Active Comparator: Garmin Forerunner 235<br>Garmin Forerunner 235 Heart Rate Monitoring Device | Device: Fit Bit Blaze<br>* Fit Bit Blaze Heart Rate Monitoring Device<br>Device: Garmin Forerunner 235<br>* Garmin Forerunner 235 Heart Rate Monitoring Device<br>Device: Tom Tom Spark Cardio<br>* Tom Tom Spark Cardio Heart Rate Monitoring Device<br>Device: Apple Watch<br>* Apple Watch Heart Rate Monitoring Device<br>|
| Active Comparator: Tom Tom Spark Cardio<br>Tom Tom Spark Cardio Heart Rate Monitoring Device | Device: Fit Bit Blaze<br>* Fit Bit Blaze Heart Rate Monitoring Device<br>Device: Garmin Forerunner 235<br>* Garmin Forerunner 235 Heart Rate Monitoring Device<br>Device: Tom Tom Spark Cardio<br>* Tom Tom Spark Cardio Heart Rate Monitoring Device<br>Device: Apple Watch<br>* Apple Watch Heart Rate Monitoring Device<br>|
| Active Comparator: Apple Watch<br>Apple Watch Heart Rate Monitoring Device | Device: Fit Bit Blaze<br>* Fit Bit Blaze Heart Rate Monitoring Device<br>Device: Garmin Forerunner 235<br>* Garmin Forerunner 235 Heart Rate Monitoring Device<br>Device: Tom Tom Spark Cardio<br>* Tom Tom Spark Cardio Heart Rate Monitoring Device<br>Device: Apple Watch<br>* Apple Watch Heart Rate Monitoring Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Monitor Accuracy Compared to ECG | The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient. | 16 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WEARABLE HEART RATE MONITORS, ACCURACY