Cardiac RehabilitationNCT03182439
Accuracy of Commercially Available Heart Rate Monitors III
A study testing Fit Bit Blaze, Garmin Forerunner 235 and Tom Tom Spark Cardio in people with Cardiac Rehabilitation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Fit Bit Blaze, Garmin Forerunner 235 and Tom Tom Spark Cardio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 11 Oct 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study
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.
Read the detailed 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:
- Two different optical heart rate monitors (one on each wrist)
- A Polar chest-strap based monitor
- 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:
- Pre-exercise
- Treadmill: at 3, 5 and 7 min.
- Stationary Cycle: at 3, 5 and 7 min.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio, Apple Watch
- Keywords
- WEARABLE HEART RATE MONITORS, ACCURACY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit Bit BlazeDevice
Fit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235Device
Garmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark CardioDevice
Tom Tom Spark Cardio Heart Rate Monitoring Device
Apple WatchDevice
Apple Watch Heart Rate Monitoring Device
| Study group | Role | What they receive |
|---|---|---|
| Fit Bit Blaze | Active comparator | Fit Bit Blaze Heart Rate Monitoring Device Receives: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch |
| Garmin Forerunner 235 | Active comparator | Garmin Forerunner 235 Heart Rate Monitoring Device Receives: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch |
| Tom Tom Spark Cardio | Active comparator | Tom Tom Spark Cardio Heart Rate Monitoring Device Receives: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch |
| Apple Watch | Active comparator | Apple Watch Heart Rate Monitoring Device Receives: Device: Fit Bit Blaze; Device: Garmin Forerunner 235; Device: Tom Tom Spark Cardio; Device: Apple Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Monitor Accuracy Compared to ECG
The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient.
Measured: 16 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start22 Jun 2017
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT03182439
- Sponsor's protocol ID
- 17-661
- Status last verified
- Oct 2017
- First submitted
- 7 Jun 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. No abstract available.
PubMed 27732703
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03182439
- Acronym / sponsor ID
- 17-661
- Conditions
- Cardiac Rehabilitation
- Keywords
- WEARABLE HEART RATE MONITORS, ACCURACY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 9 Jun 2017 (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 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.
Detailed 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:
- Two different optical heart rate monitors (one on each wrist)
- A Polar chest-strap based monitor
- 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:
- Pre-exercise
- Treadmill: at 3, 5 and 7 min.
- Stationary Cycle: at 3, 5 and 7 min.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fit Bit Blaze | Active comparator | Device: Fit Bit Blaze, Device: Garmin Forerunner 235, Device: Tom Tom Spark Cardio, Device: Apple WatchFit Bit Blaze Heart Rate Monitoring Device |
| Garmin Forerunner 235 | Active comparator | Device: Fit Bit Blaze, Device: Garmin Forerunner 235, Device: Tom Tom Spark Cardio, Device: Apple WatchGarmin Forerunner 235 Heart Rate Monitoring Device |
| Tom Tom Spark Cardio | Active comparator | Device: Fit Bit Blaze, Device: Garmin Forerunner 235, Device: Tom Tom Spark Cardio, Device: Apple WatchTom Tom Spark Cardio Heart Rate Monitoring Device |
| Apple Watch | Active comparator | Device: Fit Bit Blaze, Device: Garmin Forerunner 235, Device: Tom Tom Spark Cardio, Device: Apple WatchApple Watch Heart Rate Monitoring Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus
Key exclusion criteria (4 listed)
- 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
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 BlazeFit Bit Blaze Heart Rate Monitoring Device | Device | Apple Watch, Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio |
| Garmin Forerunner 235Garmin Forerunner 235 Heart Rate Monitoring Device | Device | Apple Watch, Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio |
| Tom Tom Spark CardioTom Tom Spark Cardio Heart Rate Monitoring Device | Device | Apple Watch, Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio |
| Apple WatchApple Watch Heart Rate Monitoring Device | Device | Apple Watch, Fit Bit Blaze, Garmin Forerunner 235, Tom Tom Spark Cardio |
Primary outcome
Heart Rate Monitor Accuracy Compared to ECG
Time frame: 16 minutes
The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient.
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 19 Oct 2017.
- Results publication: PubMed 27732703Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. No abstract available.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit Bit Blaze, Garmin Forerunner 235 and Tom Tom Spark Cardio in people with Cardiac Rehabilitation, 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 4 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 19 Oct 2017. 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?
Heart Rate Monitor Accuracy Compared to ECG (time frame: 16 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182439, which also lists 1 linked publication.
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 19 Oct 2017.