Accuracy of Commercially Available Heart Rate Monitors III

Cardiac Rehabilitation Clinical Trial

Official title:

Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182439
• Other study ID #: 17-661
• Status: Completed
• Phase: N/A
• First received: June 7, 2017
• Last updated: October 17, 2017
• Start date: June 22, 2017
• Est. completion date: October 11, 2017

Study information

• Verified date: October 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the accuracy of four heart rate monitors in cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving exercise on a treadmill and/or stationary bicycle.

Description:

This study will assess the accuracy of four of the best-selling optical heart rate monitors when worn by cardiac rehabilitation patients.

During testing, each subject will wear:

1. Two different optical heart rate monitors (one on each wrist)

2. A Polar chest-strap based monitor

3. ECG leads

The types of wrist-worn heart rate monitors assigned to each subject will be randomly assigned.

The location (left or right wrist) will also be randomly assigned.

Heart rate will be assessed using each of the 4 monitors with the subject on the exercise machines under each of the following conditions:

1. Pre-exercise

2. Treadmill: at 3, 5 and 7 min.

3. Stationary Cycle: at 3, 5 and 7 min.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus

Exclusion Criteria:

• Presence of a cardiac pacemaker

• Known chronic and persistent heart rhythm disorders

• Tattoos around the wrist or forearm area

• Use of a radial artery graft for coronary artery bypass grafting

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Device:
• Fit Bit Blaze
Fit Bit Blaze Heart Rate Monitoring Device
• Garmin Forerunner 235
Garmin Forerunner 235 Heart Rate Monitoring Device
• Tom Tom Spark Cardio
Tom Tom Spark Cardio Heart Rate Monitoring Device
• Apple Watch
Apple Watch Heart Rate Monitoring Device

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Monitor Accuracy Compared to ECG	The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient.	16 minutes