Accuracy of Commercially Available Heart Rate Monitors II

Study Overview
=================
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.

Official Title
-----------------
Accuracy of Commercially Available Heart Rate Monitors II

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
commercial heart monitors, accuracy, EKG, varying degrees of exertion