An interventional study of Fit Bit Blaze Heart Rate Monitoring Device and Garmin Forerunner 235 Heart Rate Monitoring Device in Healthy, sponsored by The Cleveland Clinic. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Screening
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.
The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fit Bit Blaze Heart Rate Monitoring Device
Device: Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235 Heart Rate Monitoring Device
Device: Garmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark Cardio Heart Rate Monitoring Device
Device: Tom Tom Spark Cardio Heart Rate Monitoring Device
Apple Watch Heart Rate Monitoring Device
Device: Apple Watch Heart Rate Monitoring Device
Scosche Rhythm + Heart Rate Monitoring Device
Device: Scosche Rhythm + Heart Rate Monitor
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
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.
| Milestone | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch |
|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 |
| Completed | 25 | 25 | 25 | 25 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Concordance Correlation Coefficient wECG | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch |
|---|---|---|---|---|
| Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. | .67 (.615 to .719) | .81 (.776 to .843) | .83 (.799 to .860) | .92 (.903 to .934) |
Collected over 24 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fit Bit Blaze | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Garmin Forerunner 235 | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Tom Tom Spark Cardio | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Apple Watch | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Heart Rate) | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 25 | 25 | 100 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Heart Rate) | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch | Total |
|---|---|---|---|---|---|
| Female | 14 | 12 | 15 | 13 | 54 |
| Male | 11 | 13 | 10 | 12 | 46 |
| Race and Ethnicity Not Collected(Participants) | Fit Bit Blaze | Garmin Forerunner 235 | Tom Tom Spark Cardio | Apple Watch | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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