Accuracy of Commercially Available Heart Rate Monitors II
1 other identifier
interventional
50
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Jun 2016
Shorter than P25 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedJuly 2, 2017
June 1, 2017
4 months
June 22, 2016
April 18, 2017
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 minutes
Study Arms (5)
Fit Bit Blaze
ACTIVE COMPARATORFit Bit Blaze Heart Rate Monitoring Device
Garmin Forerunner 235
ACTIVE COMPARATORGarmin Forerunner 235 Heart Rate Monitoring Device
Tom Tom Spark Cardio
ACTIVE COMPARATORTom Tom Spark Cardio Heart Rate Monitoring Device
Apple Watch
ACTIVE COMPARATORApple Watch Heart Rate Monitoring Device
Scosche Rhythm +
ACTIVE COMPARATORScosche Rhythm + Heart Rate Monitoring Device
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Able and willing to exercise for a total of fifteen minutes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc Gillinov MD
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gillinov, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2016
First Posted
June 29, 2016
Study Start
June 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
July 2, 2017
Results First Posted
July 2, 2017
Record last verified: 2017-06