NCT03612063

Brief Summary

The purpose of this research is to compare four different heart rate monitors (Apple Watch Nike III,Fitbit Iconic, Garmin Vivosmart HR, Tom Tom Spark 3) to an Electrocardiograph (ECG) machine to determine the accuracy of the devices. Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Elite athletes often use heart rate measurements to monitor training and fitness levels. In response, fitness companies have offered a variety of heart rate monitors to the general public. Previously, chest strap monitors that measured electrical activity were mainly used to track heart rates. More recently, wrist-worn monitors that use an optical sensor (light) to measure heart rate have gained in popularity. While the accuracy of chest strap monitors has been studied, there is currently no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important for subjects who rely upon the heart rate measurements to guide their athletic activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

July 27, 2018

Last Update Submit

April 8, 2019

Conditions

Heart Rate MonitorsAthletes Heart

Outcome Measures

Primary Outcomes (1)

  • HR Monitor Assessment

    HR monitor values on each of the two wrist watches will be recorded along with the HR found on the Polar chest strap and ECG. In each running condition, heart rate will be assessed at 2 minutes of activity in order to ensure that a steady state heart rate has been achieved.

    2 minutes of activity

Study Arms (6)

Fitbit Iconic HR and Garmin Vivosmart HR

EXPERIMENTAL
Device: Fitbit Iconic HR and Garmin Vivosmart HR

Fitbit Iconic HR and TomTom Spark 3

EXPERIMENTAL
Device: Fitbit Iconic HR and TomTom Spark 3

Garmin Vivosmart HR and TomTom Spark 3

EXPERIMENTAL
Device: Garmin Vivosmart HR and TomTom Spark 3

Fitbit Iconic HR and Apple Watch III

EXPERIMENTAL
Device: Fitbit Iconic HR and Apple Watch III

Apple Watch III and Garmin Vivosmart HR

EXPERIMENTAL
Device: Apple Watch III and Garmin Vivosmart HR

Apple Watch III and TomTom Spark 3

EXPERIMENTAL
Device: Apple Watch III and TomTom Spark 3

Interventions

Fitbit Iconic HR and Garmin Vivosmart HRDEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Fitbit Iconic HR and Garmin Vivosmart HR
Fitbit Iconic HR and TomTom Spark 3DEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Fitbit Iconic HR and TomTom Spark 3
Garmin Vivosmart HR and TomTom Spark 3DEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Garmin Vivosmart HR and TomTom Spark 3
Fitbit Iconic HR and Apple Watch IIIDEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Fitbit Iconic HR and Apple Watch III
Apple Watch III and Garmin Vivosmart HRDEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Apple Watch III and Garmin Vivosmart HR
Apple Watch III and TomTom Spark 3DEVICE

During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions: 1. At rest 2. 4 mph 3. 5 mph 4. 6 mph 5. 7 mph 6. 8 mph 7. 9 mph 8. Post-exercise 1 minute 9. Post exercise 2 minutes

Apple Watch III and TomTom Spark 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Patients are able to run a mile in 7 minutes or less

You may not qualify if:

  • Presence of a cardiac pacemaker
  • Known chronic and persistent heart rhythm disorders
  • Tattoos around the wrist or forearm area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Milind Desai, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The five heart rate monitors that will be assessed in this study include the Apple Watch Nike III, Fitbit Iconic, Garmin Vivosmart HR, TomTom Spark 3, and Polar H7 heart rate sensor. During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be assigned, by chance to one of six groups: 1. Fitbit Iconic HR and Garmin Vivosmart HR 2. Fitbit Iconic HR and TomTom Spark 3 3. Fitbit Iconic HR and Apple Watch III 4. Apple Watch III and Garmin Vivosmart HR 5. Apple Watch III and TomTom Spark 3 6. Garmin Vivosmart HR and TomTom Spark 3
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

July 24, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)