Accuracy of Commercially Available Heart Rate Monitors III

Not Applicable

Completed

• Conditions: Cardiac Rehabilitation
• Interventions: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch

• Registration Number: NCT03182439
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Study Start: 2017-06-22
• Status Verified: 2017-10
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fit Bit Blaze	Fit Bit Blaze	Fit Bit Blaze Heart Rate Monitoring Device
Fit Bit Blaze	Apple Watch	Fit Bit Blaze Heart Rate Monitoring Device
Fit Bit Blaze	Garmin Forerunner 235	Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235	Garmin Forerunner 235	Garmin Forerunner 235 Heart Rate Monitoring Device
Fit Bit Blaze	Tom Tom Spark Cardio	Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235	Apple Watch	Garmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark Cardio	Fit Bit Blaze	Tom Tom Spark Cardio Heart Rate Monitoring Device
Tom Tom Spark Cardio	Garmin Forerunner 235	Tom Tom Spark Cardio Heart Rate Monitoring Device
Tom Tom Spark Cardio	Tom Tom Spark Cardio	Tom Tom Spark Cardio Heart Rate Monitoring Device
Tom Tom Spark Cardio	Apple Watch	Tom Tom Spark Cardio Heart Rate Monitoring Device
Garmin Forerunner 235	Fit Bit Blaze	Garmin Forerunner 235 Heart Rate Monitoring Device
Garmin Forerunner 235	Tom Tom Spark Cardio	Garmin Forerunner 235 Heart Rate Monitoring Device
Apple Watch	Garmin Forerunner 235	Apple Watch Heart Rate Monitoring Device
Apple Watch	Apple Watch	Apple Watch Heart Rate Monitoring Device
Apple Watch	Fit Bit Blaze	Apple Watch Heart Rate Monitoring Device
Apple Watch	Tom Tom Spark Cardio	Apple Watch Heart Rate Monitoring Device

Primary Outcome Measures

Name	Time	Method
Heart Rate Monitor Accuracy Compared to ECG	16 minutes	The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States