Healthy
Conditions
Keywords
commercial heart monitors, accuracy, EKG, varying degrees of exertion
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.
Interventions
DEVICEFit Bit Blaze Heart Rate Monitoring Device
DEVICEGarmin Forerunner 235 Heart Rate Monitoring Device
DEVICETom Tom Spark Cardio Heart Rate Monitoring Device
DEVICEApple Watch Heart Rate Monitoring Device
DEVICEScosche Rhythm + Heart Rate Monitor
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
All subjects who met inclusion criteria and had no exclusions were enrolled. All subjects who were consented, participated and completed the study wearing a device on each wrist.
Participants by arm
| Arm | Count |
|---|---|
| Fit Bit Blaze Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Fit Bit Blaze Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Garmin Forerunner 235 Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Garmin Forerunner 235 Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Tom Tom Spark Cardio Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Tom Tom Spark Cardio Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Apple Watch Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Apple Watch Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 25 |
| Total | 200 |
Baseline characteristics
| Characteristic | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate |
| Age, Categorical >=65 years | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate | 0 Heart Rate |
| Age, Categorical Between 18 and 65 years | 25 Heart Rate | 25 Heart Rate | 25 Heart Rate | 25 Heart Rate | 100 Heart Rate |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Heart Rate | 12 Heart Rate | 15 Heart Rate | 13 Heart Rate | 54 Heart Rate |
| Sex: Female, Male Male | 11 Heart Rate | 13 Heart Rate | 10 Heart Rate | 12 Heart Rate | 46 Heart Rate |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: 24 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fit Bit Blaze | Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. | .67 Concordance Correlation Coefficient wECG |
| Garmin Forerunner 235 | Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. | .81 Concordance Correlation Coefficient wECG |
| Tom Tom Spark Cardio | Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. | .83 Concordance Correlation Coefficient wECG |
| Apple Watch | Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. | .92 Concordance Correlation Coefficient wECG |