Trial Outcomes & Findings for Accuracy of Commercially Available Heart Rate Monitors (NCT NCT02697214)
NCT ID: NCT02697214
Last Updated: 2019-02-11
Results Overview
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors compared to the current gold standard of a ECG using Lin's Concordance Correlation Coefficient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
20 minutes
Results posted on
2019-02-11
Participant Flow
All 50 subjects wore 4 monitors each. i.e. EKG, H7 polar monitor, and 2 other randomly assigned heart rate monitors.
Unit of analysis: Heart Rate monitors
Participant milestones
| Measure |
Apple Watch
Participants wore Polar H7 chest monitor, standard ECG and Apple Watch and one other wrist monitor.
|
Fitbit Charge HR
Participants wore Polar H7 chest monitor, standard ECG and Fitbit Charge HR and one other wrist monitor.
|
Mio Fuse
Participants wore Polar H7 chest monitor, standard ECG and Mio Fuse and one other wrist monitor.
|
Basis Peak
Participants wore Polar H7 chest monitor and Basis Peak and one other wrist monitor.
|
Polar HR
All participants wore Polar HR chest monitor
|
Standard ECG
All participants wore standard ECG
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
Heart Rate at 2mph
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
Heart Rate at 3mph
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
Heart Rate at 4mph
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
Heart Rate at 6mph
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
COMPLETED
|
26 26
|
25 25
|
25 25
|
24 24
|
50 50
|
50 50
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
As each participant was assigned to wear two wrist-worn heart rate monitors.
Baseline characteristics by cohort
| Measure |
Apple Watch
n=26 Heart Rate Monitors
Apple Watch heart rate monitoring device.
Apple Watch: Apple Watch heart rate monitoring device.
|
Fitbit Charge HR
n=25 Heart Rate Monitors
Fitbit Charge HR heart rate monitoring device.
Fitbit Charge HR: Fitbit Charge HR heart rate monitoring device.
|
Mio Fuse
n=25 Heart Rate Monitors
Mio Fuse heart rate monitoring device.
Mio Fuse: Mio Fuse heart rate monitoring device.
|
Basis Peak
n=24 Heart Rate Monitors
Basis Peak heart rate monitoring device.
Basis Peak: Basis Peak heart rate monitoring device.
|
Total
n=100 Heart Rate Monitors
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Age, Customized
Between 18 and 65 years
|
26 participants
n=99 Participants
|
25 participants
n=107 Participants
|
25 participants
n=206 Participants
|
24 participants
n=7 Participants
|
50 participants
n=31 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Sex/Gender, Customized
Female
|
19 participants
n=99 Participants
|
12 participants
n=107 Participants
|
14 participants
n=206 Participants
|
13 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
Sex/Gender, Customized
Male
|
7 participants
n=99 Participants
|
13 participants
n=107 Participants
|
11 participants
n=206 Participants
|
11 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants • As each participant was assigned to wear two wrist-worn heart rate monitors.
|
25 participants
n=107 Participants • As each participant was assigned to wear two wrist-worn heart rate monitors.
|
25 participants
n=206 Participants • As each participant was assigned to wear two wrist-worn heart rate monitors.
|
24 participants
n=7 Participants • As each participant was assigned to wear two wrist-worn heart rate monitors.
|
50 participants
n=31 Participants • As each participant was assigned to wear two wrist-worn heart rate monitors.
|
PRIMARY outcome
Timeframe: 20 minutesPopulation: All participants are represented in the analysis population.
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors compared to the current gold standard of a ECG using Lin's Concordance Correlation Coefficient.
Outcome measures
| Measure |
Apple Watch
n=26 Heart Rate Monitors
Apple Watch heart rate monitoring device.
Apple Watch: Apple Watch heart rate monitoring device.
|
Fitbit Charge HR
n=25 Heart Rate Monitors
Fitbit Charge HR heart rate monitoring device.
Fitbit Charge HR: Fitbit Charge HR heart rate monitoring device.
|
Mio Fuse
n=25 Heart Rate Monitors
Mio Fuse heart rate monitoring device.
Mio Fuse: Mio Fuse heart rate monitoring device.
|
Basis Peak
n=24 Heart Rate Monitors
Basis Peak heart rate monitoring device.
Basis Peak: Basis Peak heart rate monitoring device.
|
|---|---|---|---|---|
|
Measuring the Accuracy of Commercial Heart Rate Monitors.
|
.91 Correlation Coefficient
Interval 0.884 to 0.929
|
.84 Correlation Coefficient
Interval 0.791 to 0.872
|
.91 Correlation Coefficient
Interval 0.882 to 0.929
|
.83 Correlation Coefficient
Interval 0.779 to 0.865
|
Adverse Events
Apple Watch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fitbit Charge HR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mio Fuse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Basis Peak
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place