Heart Rate MonitorsHRMNCT03612063
Accuracy of Commercially Available Heart Rate Monitors in Athletes
A study testing Fitbit Iconic HR and Garmin Vivosmart HR, Fitbit Iconic HR and TomTom Spark 3 and Garmin Vivosmart HR and TomTom Spark 3 in people with Heart Rate Monitors and Athletes Heart, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Monitors, Athletes Heart
- What is being tested?
- Fitbit Iconic HR and Garmin Vivosmart HR, Fitbit Iconic HR and TomTom Spark 3 and Garmin Vivosmart HR and TomTom Spark 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 13 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients are able to run a mile in 7 minutes or less
Who cannot join
- Presence of a cardiac pacemaker
- Known chronic and persistent heart rhythm disorders
- Tattoos around the wrist or forearm area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Commercially Available Heart Rate Monitors in Athletes: A Prospective, Randomized Study
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.
Read the detailed description
In 2018, worldwide sales of wearable fitness monitors are anticipated to exceed 110 million. Millions of consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment and awareness of the accuracy of heart rate measurements becomes increasingly important.
In previous trials, the investigators assessed the accuracy of 4 wrist-worn HR monitors (Apple Watch, Fitbit Blaze, Garmin Forerunner 235, TomTom Spark Cardio) in healthy adult volunteers during various types of exercise. The investigators discovered that the accuracy varied with exercise type. With the treadmill, all devices were acceptable (rc =.88-.93) except the Fitbit Blaze (rc=.76). While biking, the Garmin and Apple Watch were acceptable (rc >.8). On the elliptical trainer without arm levers, only the Apple Watch provided accurate readings (rc=.94). None of the devices gave accurate readings for the elliptical trainer with arm levers (rc <.8). That study is now published.
Reviewers of the investigator's previous work raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate in athletes performing at a high level of exertion? This study addresses that question.
The objective of this study is to evaluate the accuracy of four heart rate monitors in accomplished athletes (i.e. runners) performing at various levels of exertion, including a high level of exertion.
- Conditions
- Heart Rate Monitors, Athletes Heart
- Being tested
- Fitbit Iconic HR and Garmin Vivosmart HR, Fitbit Iconic HR and TomTom Spark 3, Garmin Vivosmart HR and TomTom Spark 3, Fitbit Iconic HR and Apple Watch III, Apple Watch III and Garmin Vivosmart HR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
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:
- At rest
- 4 mph
- 5 mph
- 6 mph
- 7 mph
- 8 mph
- 9 mph
- Post-exercise 1 minute
- Post exercise 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Fitbit Iconic HR and Garmin Vivosmart HR | Experimental | Not described Receives: Device: Fitbit Iconic HR and Garmin Vivosmart HR |
| Fitbit Iconic HR and TomTom Spark 3 | Experimental | Not described Receives: Device: Fitbit Iconic HR and TomTom Spark 3 |
| Garmin Vivosmart HR and TomTom Spark 3 | Experimental | Not described Receives: Device: Garmin Vivosmart HR and TomTom Spark 3 |
| Fitbit Iconic HR and Apple Watch III | Experimental | Not described Receives: Device: Fitbit Iconic HR and Apple Watch III |
| Apple Watch III and Garmin Vivosmart HR | Experimental | Not described Receives: Device: Apple Watch III and Garmin Vivosmart HR |
| Apple Watch III and TomTom Spark 3 | Experimental | Not described Receives: Device: Apple Watch III and TomTom Spark 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes of activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start24 Jul 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate MonitorsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milind Desai, The Cleveland Clinic
- Investigators
- Milind Desai, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612063
- Sponsor's protocol ID
- 18-800
- Acronym
- HRM
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Commercially Available Heart Rate Monitors in Athletes: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03612063
- Acronym / sponsor ID
- HRM / 18-800
- Conditions
- Heart Rate Monitors, Athletes Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In 2018, worldwide sales of wearable fitness monitors are anticipated to exceed 110 million. Millions of consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment and awareness of the accuracy of heart rate measurements becomes increasingly important.
In previous trials, the investigators assessed the accuracy of 4 wrist-worn HR monitors (Apple Watch, Fitbit Blaze, Garmin Forerunner 235, TomTom Spark Cardio) in healthy adult volunteers during various types of exercise. The investigators discovered that the accuracy varied with exercise type. With the treadmill, all devices were acceptable (rc =.88-.93) except the Fitbit Blaze (rc=.76). While biking, the Garmin and Apple Watch were acceptable (rc >.8). On the elliptical trainer without arm levers, only the Apple Watch provided accurate readings (rc=.94). None of the devices gave accurate readings for the elliptical trainer with arm levers (rc <.8). That study is now published.
Reviewers of the investigator's previous work raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate in athletes performing at a high level of exertion? This study addresses that question.
The objective of this study is to evaluate the accuracy of four heart rate monitors in accomplished athletes (i.e. runners) performing at various levels of exertion, including a high level of exertion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients are able to run a mile in 7 minutes or less
Key exclusion criteria (3 listed)
- Presence of a cardiac pacemaker
- Known chronic and persistent heart rhythm disorders
- Tattoos around the wrist or forearm area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Iconic HR and Garmin Vivosmart HRDuring 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 | Device | Fitbit Iconic HR and Garmin Vivosmart HR |
| Fitbit Iconic HR and TomTom Spark 3During 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 | Device | Fitbit Iconic HR and TomTom Spark 3 |
| Garmin Vivosmart HR and TomTom Spark 3During 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 | Device | Garmin Vivosmart HR and TomTom Spark 3 |
| Fitbit Iconic HR and Apple Watch IIIDuring 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 | Device | Fitbit Iconic HR and Apple Watch III |
| Apple Watch III and Garmin Vivosmart HRDuring 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 | Device | Apple Watch III and Garmin Vivosmart HR |
| Apple Watch III and TomTom Spark 3During 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 | Device | Apple Watch III and TomTom Spark 3 |
Primary outcome
HR Monitor Assessment
Time frame: 2 minutes of activity
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milind Desai, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Iconic HR and Garmin Vivosmart HR, Fitbit Iconic HR and TomTom Spark 3 and Garmin Vivosmart HR and TomTom Spark 3 in people with Heart Rate Monitors and Athletes Heart, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR Monitor Assessment (time frame: 2 minutes of activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.