HealthyHRMNCT02697214
Accuracy of Commercially Available Heart Rate Monitors
A study testing Fitbit Charge HR, Apple Watch and Mio Fuse in people with Healthy, run by The Cleveland Clinic.
Trial summary
Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring systems to the general public. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fitbit Charge HR, Apple Watch and Mio Fuse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able and willing to exercise (walk/jog) for a total of fifteen minutes
Who cannot join
- Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
- Presence of a cardiac pacemaker
- Known cardiovascular disease
- Known heart rhythm disorders
- Use of Beta-blockers or antiarrhythmic medications
- Tattoos around the wrist area
About this study
Official title: Accuracy of Commercially Available Heart Rate Monitors: A Prospective Study
Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring systems to the general public. Recently, there has been a move from monitors that rely on chest straps to measure electrical activity toward more convenient, wrist-worn monitors that employ optical sensing technology similar to that used for pulse oximetry. While the accuracy of chest strap monitors has been assessed in a variety of studies, there is no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important both for the subjects who rely upon these monitors to guide their athletic activity and for the physicians to whom these individuals report their heart rate readings.
Read the detailed description
Physicians have long-used heart rate as an index of aerobic fitness and cardiovascular health. Resting heart rate has been linked to longevity and freedom from cardiovascular morbidity, and heart rate during exercise serves as a measure of aerobic capacity. In addition, heart rate recovery after exercise carries implications for an individuals' health.
Like physicians, coaches and athletic trainers employ heart rate measurement on a daily basis. In the athletic setting, heart rate during exercise is used as an indication of aerobic exertion. Elite athletes and their coaches often design workouts based upon achieved and targeted heart rates.
Once the province of physicians and elite athletes, heart rate monitoring has become widespread among the general public. In the nineteen eighties, fitness companies added heart rate monitors to their product lines. Systems employing a chest strap to monitor electrical activity, telemetry and a wrist-borne receiver became popular, and several controlled, scientific studies confirmed their accuracy.
More recently, manufacturers have marketed a new class of heart rate monitors that consist solely of wristwatch-style devices. These heart rate monitors use optical sensing technology to measure heart rate. While they offer convenience, their accuracy, particularly during exercise, is uncertain. A recent article in USA Today suggests that these wrist-worn monitors fail to provide accurate readings during exercise; however, to date there has been no rigorous scientific inquiry addressing this question.
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors under conditions of varying physical exertion.
- Conditions
- Healthy
- Being tested
- Fitbit Charge HR, Apple Watch, Mio Fuse, Basis Peak
- Keywords
- commercial heart rate monitors, accuracy, ECG, varying degrees of exertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Charge HRDevice
Fitbit Charge HR heart rate monitoring device compared to ECG and Polar H7
Apple WatchDevice
Apple Watch heart rate monitoring device compared to ECG and Polar H7
Mio FuseDevice
Mio Fuse heart rate monitoring device compared to ECG and Polar H7
Basis PeakDevice
Basis Peak heart rate monitoring device compared to ECG and Polar H7
| Study group | Role | What they receive |
|---|---|---|
| Apple Watch | Active comparator | Apple Watch heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device . Receives: Device: Apple Watch |
| Fitbit Charge HR | Active comparator | Fitbit Charge HR heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. Receives: Device: Fitbit Charge HR |
| Mio Fuse | Active comparator | Mio Fuse heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. Receives: Device: Mio Fuse |
| Basis Peak | Active comparator | Basis Peak heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. Receives: Device: Basis Peak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Accuracy of Commercial Heart Rate Monitors.
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors compared to the current gold standard of a ECG using Lin's Concordance Correlation Coefficient.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- 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, Marc Gillinov, MD, The Cleveland Clinic
- Investigators
- Marc Gillinov, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697214
- Sponsor's protocol ID
- 15-718
- Acronym
- HRM
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2016
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Commercially Available Heart Rate Monitors: A Prospective Study
- ClinicalTrials.gov ID
- NCT02697214
- Acronym / sponsor ID
- HRM / 15-718
- Conditions
- Healthy
- Keywords
- commercial heart rate monitors, accuracy, ECG, varying degrees of exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the last two decades, there has been a proliferation of commercially available heart rate monitors. Recognizing that elite athletes often use heart rate to monitor training and assess aerobic fitness, fitness companies have offered a variety of heart rate monitoring systems to the general public. Recently, there has been a move from monitors that rely on chest straps to measure electrical activity toward more convenient, wrist-worn monitors that employ optical sensing technology similar to that used for pulse oximetry. While the accuracy of chest strap monitors has been assessed in a variety of studies, there is no data concerning the accuracy of wrist-worn heart rate monitors. Assessment of the monitors' accuracy is important both for the subjects who rely upon these monitors to guide their athletic activity and for the physicians to whom these individuals report their heart rate readings.
Detailed description
Physicians have long-used heart rate as an index of aerobic fitness and cardiovascular health. Resting heart rate has been linked to longevity and freedom from cardiovascular morbidity, and heart rate during exercise serves as a measure of aerobic capacity. In addition, heart rate recovery after exercise carries implications for an individuals' health.
Like physicians, coaches and athletic trainers employ heart rate measurement on a daily basis. In the athletic setting, heart rate during exercise is used as an indication of aerobic exertion. Elite athletes and their coaches often design workouts based upon achieved and targeted heart rates.
Once the province of physicians and elite athletes, heart rate monitoring has become widespread among the general public. In the nineteen eighties, fitness companies added heart rate monitors to their product lines. Systems employing a chest strap to monitor electrical activity, telemetry and a wrist-borne receiver became popular, and several controlled, scientific studies confirmed their accuracy.
More recently, manufacturers have marketed a new class of heart rate monitors that consist solely of wristwatch-style devices. These heart rate monitors use optical sensing technology to measure heart rate. While they offer convenience, their accuracy, particularly during exercise, is uncertain. A recent article in USA Today suggests that these wrist-worn monitors fail to provide accurate readings during exercise; however, to date there has been no rigorous scientific inquiry addressing this question.
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors under conditions of varying physical exertion.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apple Watch | Active comparator | Device: Apple WatchApple Watch heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device . |
| Fitbit Charge HR | Active comparator | Device: Fitbit Charge HRFitbit Charge HR heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. |
| Mio Fuse | Active comparator | Device: Mio FuseMio Fuse heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. |
| Basis Peak | Active comparator | Device: Basis PeakBasis Peak heart rate monitoring device worn with standard ECG, Polar H7 chest monitor and one other wrist monitoring device. |
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
- Able and willing to exercise (walk/jog) for a total of fifteen minutes
Key exclusion criteria (6 listed)
- Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
- Presence of a cardiac pacemaker
- Known cardiovascular disease
- Known heart rhythm disorders
- Use of Beta-blockers or antiarrhythmic medications
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 Charge HRFitbit Charge HR heart rate monitoring device compared to ECG and Polar H7 | Device | Fitbit Charge HR |
| Apple WatchApple Watch heart rate monitoring device compared to ECG and Polar H7 | Device | Apple Watch |
| Mio FuseMio Fuse heart rate monitoring device compared to ECG and Polar H7 | Device | Mio Fuse |
| Basis PeakBasis Peak heart rate monitoring device compared to ECG and Polar H7 | Device | Basis Peak |
Primary outcome
Measuring the Accuracy of Commercial Heart Rate Monitors.
Time frame: 20 minutes
The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors compared to the current gold standard of a ECG using Lin's Concordance Correlation Coefficient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Marc Gillinov, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Charge HR, Apple Watch and Mio Fuse in people with Healthy, run by The Cleveland Clinic.
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 6 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measuring the Accuracy of Commercial Heart Rate Monitors. (time frame: 20 minutes). 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 11 Feb 2019.