NCT02818244

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

June 22, 2016

Results QC Date

April 18, 2017

Last Update Submit

June 1, 2017

Conditions

Keywords

commercial heart monitorsaccuracyEKGvarying degrees of exertion

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 COMPARATOR

Fit Bit Blaze Heart Rate Monitoring Device

Device: Fit Bit Blaze Heart Rate Monitoring Device

Garmin Forerunner 235

ACTIVE COMPARATOR

Garmin Forerunner 235 Heart Rate Monitoring Device

Device: Garmin Forerunner 235 Heart Rate Monitoring Device

Tom Tom Spark Cardio

ACTIVE COMPARATOR

Tom Tom Spark Cardio Heart Rate Monitoring Device

Device: Tom Tom Spark Cardio Heart Rate Monitoring Device

Apple Watch

ACTIVE COMPARATOR

Apple Watch Heart Rate Monitoring Device

Device: Apple Watch Heart Rate Monitoring Device

Scosche Rhythm +

ACTIVE COMPARATOR

Scosche Rhythm + Heart Rate Monitoring Device

Device: Scosche Rhythm + Heart Rate Monitor

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Heart Rate Determination

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Results Point of Contact

Title
Marc Gillinov MD
Organization
Cleveland Clinic

Study Officials

  • Marc Gillinov, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

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