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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit Bit Blaze | Active Comparator | Fit Bit Blaze Heart Rate Monitoring Device |
|
| Garmin Forerunner 235 | Active Comparator | Garmin Forerunner 235 Heart Rate Monitoring Device |
|
| Tom Tom Spark Cardio | Active Comparator | Tom Tom Spark Cardio Heart Rate Monitoring Device |
|
| Apple Watch | Active Comparator | Apple Watch Heart Rate Monitoring Device |
|
| Scosche Rhythm + | Active Comparator | Scosche Rhythm + Heart Rate Monitoring Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fit Bit Blaze Heart Rate Monitoring Device | Device |
| ||
| Garmin Forerunner 235 Heart Rate Monitoring Device |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Gillinov, MD | The Cleveland Clinic | Principal Investigator |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | Fit Bit Blaze | Fit Bit Blaze Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| FG001 | Garmin Forerunner 235 | Garmin Forerunner 235 Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| FG002 | Tom Tom Spark Cardio | Tom Tom Spark Cardio Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| FG003 | Apple Watch | Apple Watch Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fit Bit Blaze | Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| BG001 | Garmin Forerunner 235 | Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Concordance Correlation Coefficient wECG | 24 minutes |
|
24 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fit Bit Blaze | Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Gillinov MD | Cleveland Clinic | 216 445-8841 | GILLINOM@ccf.org |
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| ID | Term |
|---|---|
| D000070276 | Heart Rate Determination |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Device |
|
| Tom Tom Spark Cardio Heart Rate Monitoring Device | Device |
|
| Apple Watch Heart Rate Monitoring Device | Device |
|
| Scosche Rhythm + Heart Rate Monitor | Device |
|
| BG002 | Tom Tom Spark Cardio | Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| BG003 | Apple Watch | Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| BG004 | Total | Total of all reporting groups |
| Heart Rate |
|
| Heart Rate |
| Heart Rate |
|
|
| Sex: Female, Male | Count of Units | Heart Rate | Heart Rate |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| OG002 | Tom Tom Spark Cardio | Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
| OG003 | Apple Watch | Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Garmin Forerunner 235 | Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Tom Tom Spark Cardio | Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Apple Watch | Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+ | 0 | 25 | 0 | 25 | 0 | 25 |
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| D010808 | Physical Examination |
| Male |
|