Accuracy of Commercially Available Heart Rate Monitors III

NCT ID: NCT03182439

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2017-10-11

Brief Summary

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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

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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.

Conditions

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Cardiac Rehabilitation

Keywords

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WEARABLE HEART RATE MONITORS, ACCURACY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fit Bit Blaze

Fit Bit Blaze Heart Rate Monitoring Device

Group Type ACTIVE_COMPARATOR

Fit Bit Blaze

Intervention Type DEVICE

Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

Intervention Type DEVICE

Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

Intervention Type DEVICE

Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

Intervention Type DEVICE

Apple Watch Heart Rate Monitoring Device

Garmin Forerunner 235

Garmin Forerunner 235 Heart Rate Monitoring Device

Group Type ACTIVE_COMPARATOR

Fit Bit Blaze

Intervention Type DEVICE

Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

Intervention Type DEVICE

Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

Intervention Type DEVICE

Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

Intervention Type DEVICE

Apple Watch Heart Rate Monitoring Device

Tom Tom Spark Cardio

Tom Tom Spark Cardio Heart Rate Monitoring Device

Group Type ACTIVE_COMPARATOR

Fit Bit Blaze

Intervention Type DEVICE

Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

Intervention Type DEVICE

Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

Intervention Type DEVICE

Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

Intervention Type DEVICE

Apple Watch Heart Rate Monitoring Device

Apple Watch

Apple Watch Heart Rate Monitoring Device

Group Type ACTIVE_COMPARATOR

Fit Bit Blaze

Intervention Type DEVICE

Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

Intervention Type DEVICE

Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

Intervention Type DEVICE

Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

Intervention Type DEVICE

Apple Watch Heart Rate Monitoring Device

Interventions

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Fit Bit Blaze

Fit Bit Blaze Heart Rate Monitoring Device

Intervention Type DEVICE

Garmin Forerunner 235

Garmin Forerunner 235 Heart Rate Monitoring Device

Intervention Type DEVICE

Tom Tom Spark Cardio

Tom Tom Spark Cardio Heart Rate Monitoring Device

Intervention Type DEVICE

Apple Watch

Apple Watch Heart Rate Monitoring Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Marc Gillinov, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Gillinov, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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. No abstract available.

Reference Type RESULT
PMID: 27732703 (View on PubMed)

Other Identifiers

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17-661

Identifier Type: -

Identifier Source: org_study_id