Accuracy of Commercially Available Heart Rate Monitors

NCT02697214 | Completed Results

• 1 other identifier: 15-718
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring systems to the general public. Recently, there has been a move from monitors that rely on chest straps to measure electrical activity toward more convenient, wrist-worn monitors that employ optical sensing technology similar to that used for pulse oximetry. While the accuracy of chest strap monitors has been assessed in a variety of studies, there is no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important both for the subjects who rely upon these monitors to guide their athletic activity and for the physicians to whom these individuals report their heart rate readings.

Conditions

Healthy

Keywords

commercial heart rate monitors; accuracy; ECG; varying degrees of exertion

Outcome Measures

Primary Outcomes (1)

• Measuring the Accuracy of Commercial Heart Rate Monitors.

  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.

  20 minutes

Study Arms (4)

Apple Watch

ACTIVE COMPARATOR

Apple Watch heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device .

Device: Apple Watch

Fitbit Charge HR

ACTIVE COMPARATOR

Fitbit Charge HR heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device.

Device: Fitbit Charge HR

Mio Fuse

ACTIVE COMPARATOR

Mio Fuse heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device.

Device: Mio Fuse

Basis Peak

ACTIVE COMPARATOR

Basis Peak heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device.

Device: Basis Peak

Interventions

Fitbit Charge HR DEVICE

Fitbit Charge HR heart rate monitoring device compared to ECG and Polar H7

Fitbit Charge HR

Apple Watch DEVICE

Apple Watch heart rate monitoring device compared to ECG and Polar H7

Apple Watch

Mio Fuse DEVICE

Mio Fuse heart rate monitoring device compared to ECG and Polar H7

Mio Fuse

Basis Peak DEVICE

Basis Peak heart rate monitoring device compared to ECG and Polar H7

Basis Peak

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Able and willing to exercise (walk/jog) for a total of fifteen minutes

You may not qualify if:

• 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 area

Sponsors & Collaborators

• The Cleveland Clinic: lead

Results Point of Contact

• Title: Marc Gillinov, MD
• Organization: The Cleveland Clinic

GILLINOM@ccf.org

216 445-8841

Study Officials

• Marc Gillinov, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 3, 2016
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share