Accuracy of Commercially Available Heart Rate Monitors II

June 1, 2017 updated by: Marc Gillinov, MD, The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.
Time Frame: 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.
24 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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