Accuracy of Commercially Available Heart Rate Monitors III

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fit Bit Blaze; Fit Bit Blaze Heart Rate Monitoring Device	Device: Fit Bit Blaze; Fit Bit Blaze Heart Rate Monitoring Device; Device: Garmin Forerunner 235; Garmin Forerunner 235 Heart Rate Monitoring Device; Device: Tom Tom Spark Cardio; Tom Tom Spark Cardio Heart Rate Monitoring Device; Device: Apple Watch; Apple Watch Heart Rate Monitoring Device
Active Comparator: Garmin Forerunner 235; Garmin Forerunner 235 Heart Rate Monitoring Device	Device: Fit Bit Blaze; Fit Bit Blaze Heart Rate Monitoring Device; Device: Garmin Forerunner 235; Garmin Forerunner 235 Heart Rate Monitoring Device; Device: Tom Tom Spark Cardio; Tom Tom Spark Cardio Heart Rate Monitoring Device; Device: Apple Watch; Apple Watch Heart Rate Monitoring Device
Active Comparator: Tom Tom Spark Cardio; Tom Tom Spark Cardio Heart Rate Monitoring Device	Device: Fit Bit Blaze; Fit Bit Blaze Heart Rate Monitoring Device; Device: Garmin Forerunner 235; Garmin Forerunner 235 Heart Rate Monitoring Device; Device: Tom Tom Spark Cardio; Tom Tom Spark Cardio Heart Rate Monitoring Device; Device: Apple Watch; Apple Watch Heart Rate Monitoring Device
Active Comparator: Apple Watch; Apple Watch Heart Rate Monitoring Device	Device: Fit Bit Blaze; Fit Bit Blaze Heart Rate Monitoring Device; Device: Garmin Forerunner 235; Garmin Forerunner 235 Heart Rate Monitoring Device; Device: Tom Tom Spark Cardio; Tom Tom Spark Cardio Heart Rate Monitoring Device; Device: Apple Watch; Apple Watch Heart Rate Monitoring Device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Marc Gillinov, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): October 11, 2017
• Study Completion (Actual): October 11, 2017

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: WEARABLE HEART RATE MONITORS, ACCURACY
• Other Study ID Numbers: 17-661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No