Accuracy of Commercially Available Heart Rate Monitors III
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2017
CompletedOctober 19, 2017
October 1, 2017
4 months
June 7, 2017
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 minutes
Study Arms (4)
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
Interventions
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
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 27732703RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gillinov, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2017
First Posted
June 9, 2017
Study Start
June 22, 2017
Primary Completion
October 11, 2017
Study Completion
October 11, 2017
Last Updated
October 19, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share