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Accuracy of Commercially Available Heart Rate Monitors II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818244
Recruitment Status : Completed
First Posted : June 29, 2016
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Marc Gillinov, MD, The Cleveland Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Device: Fit Bit Blaze Heart Rate Monitoring Device Device: Garmin Forerunner 235 Heart Rate Monitoring Device Device: Tom Tom Spark Cardio Heart Rate Monitoring Device Device: Apple Watch Heart Rate Monitoring Device Device: Scosche Rhythm + Heart Rate Monitor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Accuracy of Commercially Available Heart Rate Monitors II
Study Start Date : June 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818244


Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Marc Gillinov, MD The Cleveland Clinic
More Information
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Responsible Party: Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02818244    
Other Study ID Numbers: 16-743
First Posted: June 29, 2016    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marc Gillinov, MD, The Cleveland Clinic:
commercial heart monitors
accuracy
EKG
varying degrees of exertion