HealthyNCT02818244
Accuracy of Commercially Available Heart Rate Monitors II
A study testing Fit Bit Blaze Heart Rate Monitoring Device, Garmin Forerunner 235 Heart Rate Monitoring Device and Tom Tom Spark Cardio Heart Rate Monitoring Device in people with Healthy, run by The Cleveland Clinic.
Trial summary
In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. 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?
- Fit Bit Blaze Heart Rate Monitoring Device, Garmin Forerunner 235 Heart Rate Monitoring Device and Tom Tom Spark Cardio Heart Rate Monitoring Device
- 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
- Jun 2016to Oct 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 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 or forearm area
About this study
In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. At the elite level, commercial heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of ordinary 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 of the accuracy of heart rate measurements becomes increasingly important.
Read the detailed description
In a previous trial, investigators compared the accuracy of four devices (Apple Watch, Fitbit Charge HR, Mio Fuse, Basis Peak) worn by subjects while performing a graded exercise program on a treadmill. Investigators discovered that the Apple Watch and Mio Fuse had a correlation coefficient (rc) of .91, Fitbit Charge HR had an rc of .84, and Basis Peak had an rc of .83. That study has been submitted for publication.
Reviewers of the first study raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate during other popular forms of exercise? This study addresses that question.
Objective:
The objective of this study is to evaluate the accuracy of four heart rate monitors when used during three different exercises: treadmill, stationary bicycle, elliptical trainer.
- Conditions
- Healthy
- Being tested
- Fit Bit Blaze Heart Rate Monitoring Device, Garmin Forerunner 235 Heart Rate Monitoring Device, Tom Tom Spark Cardio Heart Rate Monitoring Device, Apple Watch Heart Rate Monitoring Device, Scosche Rhythm + Heart Rate Monitor
- Keywords
- commercial heart monitors, accuracy, EKG, varying degrees of exertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit Bit Blaze Heart Rate Monitoring DeviceDevice
Garmin Forerunner 235 Heart Rate Monitoring DeviceDevice
Tom Tom Spark Cardio Heart Rate Monitoring DeviceDevice
Apple Watch Heart Rate Monitoring DeviceDevice
Scosche Rhythm + Heart Rate MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| Fit Bit Blaze | Active comparator | Fit Bit Blaze Heart Rate Monitoring Device Receives: Device: Fit Bit Blaze Heart Rate Monitoring Device |
| Garmin Forerunner 235 | Active comparator | Garmin Forerunner 235 Heart Rate Monitoring Device Receives: Device: Garmin Forerunner 235 Heart Rate Monitoring Device |
| Tom Tom Spark Cardio | Active comparator | Tom Tom Spark Cardio Heart Rate Monitoring Device Receives: Device: Tom Tom Spark Cardio Heart Rate Monitoring Device |
| Apple Watch | Active comparator | Apple Watch Heart Rate Monitoring Device Receives: Device: Apple Watch Heart Rate Monitoring Device |
| Scosche Rhythm + | Active comparator | Scosche Rhythm + Heart Rate Monitoring Device Receives: Device: Scosche Rhythm + Heart Rate Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.
The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.
Measured: 24 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 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
- Non-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
- NCT02818244
- Sponsor's protocol ID
- 16-743
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2016
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Commercially Available Heart Rate Monitors II
- ClinicalTrials.gov ID
- NCT02818244
- Acronym / sponsor ID
- 16-743
- Conditions
- Healthy
- Keywords
- commercial heart monitors, accuracy, EKG, varying degrees of exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. At the elite level, commercial heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of ordinary 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 of the accuracy of heart rate measurements becomes increasingly important.
Detailed description
In a previous trial, investigators compared the accuracy of four devices (Apple Watch, Fitbit Charge HR, Mio Fuse, Basis Peak) worn by subjects while performing a graded exercise program on a treadmill. Investigators discovered that the Apple Watch and Mio Fuse had a correlation coefficient (rc) of .91, Fitbit Charge HR had an rc of .84, and Basis Peak had an rc of .83. That study has been submitted for publication.
Reviewers of the first study raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate during other popular forms of exercise? This study addresses that question.
Objective:
The objective of this study is to evaluate the accuracy of four heart rate monitors when used during three different exercises: treadmill, stationary bicycle, elliptical trainer.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fit Bit Blaze | Active comparator | Device: Fit Bit Blaze Heart Rate Monitoring DeviceFit Bit Blaze Heart Rate Monitoring Device |
| Garmin Forerunner 235 | Active comparator | Device: Garmin Forerunner 235 Heart Rate Monitoring DeviceGarmin Forerunner 235 Heart Rate Monitoring Device |
| Tom Tom Spark Cardio | Active comparator | Device: Tom Tom Spark Cardio Heart Rate Monitoring DeviceTom Tom Spark Cardio Heart Rate Monitoring Device |
| Apple Watch | Active comparator | Device: Apple Watch Heart Rate Monitoring DeviceApple Watch Heart Rate Monitoring Device |
| Scosche Rhythm + | Active comparator | Device: Scosche Rhythm + Heart Rate MonitorScosche Rhythm + Heart Rate 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 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 |
|---|---|---|
| Fit Bit Blaze Heart Rate Monitoring Device | Device | Fit Bit Blaze |
| Garmin Forerunner 235 Heart Rate Monitoring Device | Device | Garmin Forerunner 235 |
| Tom Tom Spark Cardio Heart Rate Monitoring Device | Device | Tom Tom Spark Cardio |
| Apple Watch Heart Rate Monitoring Device | Device | Apple Watch |
| Scosche Rhythm + Heart Rate Monitor | Device | Scosche Rhythm + |
Primary outcome
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.
Time frame: 24 minutes
The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Fit Bit Blaze Heart Rate Monitoring Device, Garmin Forerunner 235 Heart Rate Monitoring Device and Tom Tom Spark Cardio Heart Rate Monitoring Device 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 2 Jul 2017. 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 2 Jul 2017). 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?
Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient. (time frame: 24 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 2 Jul 2017.