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Completed

NCT Number: NCT03182439

Accuracy of Commercially Available Heart Rate Monitors III

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.

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Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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:

  • Two different optical heart rate monitors (one on each wrist)
  • A Polar chest-strap based monitor
  • 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:

  • Pre-exercise
  • Treadmill: at 3, 5 and 7 min.
  • Stationary Cycle: at 3, 5 and 7 min.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit Bit Blaze

Device

Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

Device

Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

Device

Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

Device

Apple Watch Heart Rate Monitoring Device

Primary outcomes

  1. Heart Rate Monitor Accuracy Compared to ECG

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2017
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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