Trial Outcomes & Findings for Accuracy of Commercially Available Heart Rate Monitors II (NCT NCT02818244)
NCT ID: NCT02818244
Last Updated: 2017-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
24 minutes
Results posted on
2017-07-02
Participant Flow
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.
Unit of analysis: Heart Rate Monitors
Participant milestones
| Measure |
Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Apple Watch
Apple Watch Heart Rate Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
25 25
|
25 25
|
|
Overall Study
COMPLETED
|
25 25
|
25 25
|
25 25
|
25 25
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fit Bit Blaze
n=25 Heart Rate
Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Garmin Forerunner 235
n=25 Heart Rate
Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Tom Tom Spark Cardio
n=25 Heart Rate
Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Apple Watch
n=25 Heart Rate
Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Total
n=100 Heart Rate
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=100 Heart Rate
|
|
Age, Categorical
Between 18 and 65 years
|
25 Heart Rate
n=25 Heart Rate
|
25 Heart Rate
n=25 Heart Rate
|
25 Heart Rate
n=25 Heart Rate
|
25 Heart Rate
n=25 Heart Rate
|
100 Heart Rate
n=100 Heart Rate
|
|
Age, Categorical
>=65 years
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=25 Heart Rate
|
0 Heart Rate
n=100 Heart Rate
|
|
Sex: Female, Male
Female
|
14 Heart Rate
n=25 Heart Rate
|
12 Heart Rate
n=25 Heart Rate
|
15 Heart Rate
n=25 Heart Rate
|
13 Heart Rate
n=25 Heart Rate
|
54 Heart Rate
n=100 Heart Rate
|
|
Sex: Female, Male
Male
|
11 Heart Rate
n=25 Heart Rate
|
13 Heart Rate
n=25 Heart Rate
|
10 Heart Rate
n=25 Heart Rate
|
12 Heart Rate
n=25 Heart Rate
|
46 Heart Rate
n=100 Heart Rate
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24 minutesThe 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.
Outcome measures
| Measure |
Fit Bit Blaze
n=25 Participants
Fit Bit Blaze Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Garmin Forerunner 235
n=25 Participants
Garmin Forerunner 235 Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Tom Tom Spark Cardio
n=25 Participants
Tom Tom Spark Cardio Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
Apple Watch
n=25 Participants
Apple Watch Heart Rate Monitoring Device Monitoring Device Standard ECG Polar Chest strap Scosche Rhythm+
|
|---|---|---|---|---|
|
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.
|
.67 Concordance Correlation Coefficient wECG
Interval 0.615 to 0.719
|
.81 Concordance Correlation Coefficient wECG
Interval 0.776 to 0.843
|
.83 Concordance Correlation Coefficient wECG
Interval 0.799 to 0.86
|
.92 Concordance Correlation Coefficient wECG
Interval 0.903 to 0.934
|
Adverse Events
Fit Bit Blaze
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Garmin Forerunner 235
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tom Tom Spark Cardio
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Apple Watch
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