Accuracy of Commercially Available Heart Rate Monitors III

NCT03182439 — Not applicable, Completed, 80 participants, The Cleveland Clinic

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

Registry	NCT03182439
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: none, other
Enrollment	80 (Actual)
Sponsor	The Cleveland Clinic (Other)
Conditions	Cardiac Rehabilitation
Interventions	Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio, Apple Watch (Device)
Dates	start 2017-06-22, primary completion 2017-10-11, completion 2017-10-11, first posted 2017-06-09, last updated 2017-10-19
Locations	1 site in United States

-Summary

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.

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+Detailed description

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:

1. Two different optical heart rate monitors (one on each wrist)
2. A Polar chest-strap based monitor
3. 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:

1. Pre-exercise
2. Treadmill: at 3, 5 and 7 min.
3. Stationary Cycle: at 3, 5 and 7 min.

+Arms and interventions

Arm	Type	Interventions	Description
Fit Bit Blaze	Active comparator	Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch	Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235	Active comparator	Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch	Garmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark Cardio	Active comparator	Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch	Tom Tom Spark Cardio Heart Rate Monitoring Device
Apple Watch	Active comparator	Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch	Apple Watch Heart Rate Monitoring Device

Fit Bit Blaze (Device): Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235 (Device): Garmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark Cardio (Device): Tom Tom Spark Cardio Heart Rate Monitoring Device
Apple Watch (Device): Apple Watch Heart Rate Monitoring Device

+Outcome measures

Primary outcomes

Heart Rate Monitor Accuracy Compared to ECG [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Cleveland Clinic	Cleveland, Ohio	United States

+Publications

Results publication: Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. No abstract available. PMID 27732703

+Investigators

Marc Gillinov, MD, Principal investigator, The Cleveland Clinic

My Notes

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