Accuracy of Commercially Available Heart Rate Monitors in Athletes (HRM)

Accuracy of Commercially Available Heart Rate Monitors in Athletes: A Prospective, Randomized Study

The purpose of this research is to compare four different heart rate monitors (Apple Watch Nike III,Fitbit Iconic, Garmin Vivosmart HR, Tom Tom Spark 3) to an Electrocardiograph (ECG) machine to determine the accuracy of the devices. Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Elite athletes often use heart rate measurements to monitor training and fitness levels. In response, fitness companies have offered a variety of heart rate monitors to the general public. Previously, chest strap monitors that measured electrical activity were mainly used to track heart rates. More recently, wrist-worn monitors that use an optical sensor (light) to measure heart rate have gained in popularity. While the accuracy of chest strap monitors has been studied, there is currently no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important for subjects who rely upon the heart rate measurements to guide their athletic activity.

Study Overview

• Status: Completed
• Conditions: Heart Rate Monitors; Athletes Heart
• Intervention / Treatment: Device: Fitbit Iconic HR and Garmin Vivosmart HR; Device: Fitbit Iconic HR and TomTom Spark 3; Device: Garmin Vivosmart HR and TomTom Spark 3; Device: Fitbit Iconic HR and Apple Watch III; Device: Apple Watch III and Garmin Vivosmart HR; Device: Apple Watch III and TomTom Spark 3

Detailed Description

In 2018, worldwide sales of wearable fitness monitors are anticipated to exceed 110 million. Millions of consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment and awareness of the accuracy of heart rate measurements becomes increasingly important.

In previous trials, the investigators assessed the accuracy of 4 wrist-worn HR monitors (Apple Watch, Fitbit Blaze, Garmin Forerunner 235, TomTom Spark Cardio) in healthy adult volunteers during various types of exercise. The investigators discovered that the accuracy varied with exercise type. With the treadmill, all devices were acceptable (rc =.88-.93) except the Fitbit Blaze (rc=.76). While biking, the Garmin and Apple Watch were acceptable (rc >.8). On the elliptical trainer without arm levers, only the Apple Watch provided accurate readings (rc=.94). None of the devices gave accurate readings for the elliptical trainer with arm levers (rc <.8). That study is now published.

Reviewers of the investigator's previous work raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate in athletes performing at a high level of exertion? This study addresses that question.

The objective of this study is to evaluate the accuracy of four heart rate monitors in accomplished athletes (i.e. runners) performing at various levels of exertion, including a high level of exertion.

• Study Type: Interventional
• Enrollment (Actual): 50
• 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 are able to run a mile in 7 minutes or less

Exclusion Criteria:

• Presence of a cardiac pacemaker
• Known chronic and persistent heart rhythm disorders
• Tattoos around the wrist or forearm area

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitbit Iconic HR and Garmin Vivosmart HR	Device: Fitbit Iconic HR and Garmin Vivosmart HR; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes
Experimental: Fitbit Iconic HR and TomTom Spark 3	Device: Fitbit Iconic HR and TomTom Spark 3; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes
Experimental: Garmin Vivosmart HR and TomTom Spark 3	Device: Garmin Vivosmart HR and TomTom Spark 3; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes
Experimental: Fitbit Iconic HR and Apple Watch III	Device: Fitbit Iconic HR and Apple Watch III; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes
Experimental: Apple Watch III and Garmin Vivosmart HR	Device: Apple Watch III and Garmin Vivosmart HR; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes
Experimental: Apple Watch III and TomTom Spark 3	Device: Apple Watch III and TomTom Spark 3; During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: At rest; 4 mph; 5 mph; 6 mph; 7 mph; 8 mph; 9 mph; Post-exercise 1 minute; Post exercise 2 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR Monitor Assessment	HR monitor values on each of the two wrist watches will be recorded along with the HR found on the Polar chest strap and ECG. In each running condition, heart rate will be assessed at 2 minutes of activity in order to ensure that a steady state heart rate has been achieved.	2 minutes of activity

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Milind Desai, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): December 13, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18-800

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