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Accuracy of Commercially Available Heart Rate Monitors III

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Completed

Conditions

Cardiac Rehabilitation

Treatments

Device: Tom Tom Spark Cardio
Device: Apple Watch
Device: Fit Bit Blaze
Device: Garmin Forerunner 235

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Fit Bit Blaze
Active Comparator group
Description:
Fit Bit Blaze Heart Rate Monitoring Device
Treatment:
Device: Apple Watch
Device: Tom Tom Spark Cardio
Device: Fit Bit Blaze
Device: Garmin Forerunner 235
Garmin Forerunner 235
Active Comparator group
Description:
Garmin Forerunner 235 Heart Rate Monitoring Device
Treatment:
Device: Apple Watch
Device: Tom Tom Spark Cardio
Device: Fit Bit Blaze
Device: Garmin Forerunner 235
Tom Tom Spark Cardio
Active Comparator group
Description:
Tom Tom Spark Cardio Heart Rate Monitoring Device
Treatment:
Device: Apple Watch
Device: Tom Tom Spark Cardio
Device: Fit Bit Blaze
Device: Garmin Forerunner 235
Apple Watch
Active Comparator group
Description:
Apple Watch Heart Rate Monitoring Device
Treatment:
Device: Apple Watch
Device: Tom Tom Spark Cardio
Device: Fit Bit Blaze
Device: Garmin Forerunner 235

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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