Accuracy of Commercially Available Heart Rate Monitors II

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Fit Bit Blaze Heart Rate Monitoring Device; Device: Apple Watch Heart Rate Monitoring Device; Device: Tom Tom Spark Cardio Heart Rate Monitoring Device; Device: Garmin Forerunner 235 Heart Rate Monitoring Device; Device: Scosche Rhythm + Heart Rate Monitor

• Registration Number: NCT02818244
• Lead Sponsor: The Cleveland Clinic

Brief Summary

In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. At the elite level, commercial heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of ordinary 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 of the accuracy of heart rate measurements becomes increasingly important.

Detailed Description

In a previous trial, investigators compared the accuracy of four devices (Apple Watch, Fitbit Charge HR, Mio Fuse, Basis Peak) worn by subjects while performing a graded exercise program on a treadmill. Investigators discovered that the Apple Watch and Mio Fuse had a correlation coefficient (rc) of .91, Fitbit Charge HR had an rc of .84, and Basis Peak had an rc of .83. That study has been submitted for publication.

Reviewers of the first study raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate during other popular forms of exercise? This study addresses that question.

Objective:

The objective of this study is to evaluate the accuracy of four heart rate monitors when used during three different exercises: treadmill, stationary bicycle, elliptical trainer.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-04-18
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > 18 years
• Able and willing to exercise for a total of fifteen minutes

Exclusion Criteria

• Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
• Presence of a cardiac pacemaker
• Known cardiovascular disease
• Known heart rhythm disorders
• Use of Beta-blockers or antiarrhythmic medications
• Tattoos around the wrist or forearm area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fit Bit Blaze	Fit Bit Blaze Heart Rate Monitoring Device	Fit Bit Blaze Heart Rate Monitoring Device
Apple Watch	Apple Watch Heart Rate Monitoring Device	Apple Watch Heart Rate Monitoring Device
Tom Tom Spark Cardio	Tom Tom Spark Cardio Heart Rate Monitoring Device	Tom Tom Spark Cardio Heart Rate Monitoring Device
Garmin Forerunner 235	Garmin Forerunner 235 Heart Rate Monitoring Device	Garmin Forerunner 235 Heart Rate Monitoring Device
Scosche Rhythm +	Scosche Rhythm + Heart Rate Monitor	Scosche Rhythm + Heart Rate Monitoring Device

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.	24 minutes	The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.