Validity and Reliability of Optical Heart Rate Sensors
ValOpti
Validity and Reliability of Consumer-Grade Optical Heart Rate Sensors to Assess Volume of Physical Activity and to Categorize Its Intensity
1 other identifier
interventional
32
1 country
1
Brief Summary
To evaluate validity and reliability of consumer-grade optical heart-rate devices we aim to compare these devices with medical-grade ECG. The design includes an extended and practical validation protocol for consumer-grade optical heart rate devices in laboratory and ambulatory free-living conditions using a medical-grade ECG device as a criterion measure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
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
Study Start
First participant enrolled
May 25, 2022
CompletedFirst Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2023
CompletedOctober 16, 2023
October 1, 2023
7 months
August 30, 2022
October 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Heart Rate
Heart rate is measured with different devices and ECG while performing different activities and free living
24 hours
Study Arms (1)
Participants aged over 35
EXPERIMENTALParticipants run through our validation protocol
Interventions
The validation protocol consists of the following activities: Activities of daily living, Exercise test on the treadmill, Exercise test on the cycle ergometer, Free-living session
Eligibility Criteria
You may qualify if:
- Age between 35 and 80 years
- All sexes
- Able to perform physical activity according to the study protocol
- Written informed consent
You may not qualify if:
- Acute infections and/or diseases
- Diseases limiting walking distance and/or physical activity outlined in the study protocol
- Atrial fibrillation
- Clinical signs of chronic venous insufficiency ≥ 1 at upper extremities
- Obesity WHO grade 2 or more (Body Mass Index \>35 kg/m²)
- Skin wound or tattoo where wearables are placed
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsinstitut für präventive und rehabilitative Sportmedizin
Salzburg, 5020, Austria
Related Publications (1)
Neudorfer M, Kumar D, Smeddinck JD, Kulnik ST, Niebauer J, Treff G, Sareban M. Validity of Four Consumer-Grade Optical Heart Rate Sensors for Assessing Volume and Intensity Distribution of Physical Activity. Scand J Med Sci Sports. 2024 Nov;34(11):e14756. doi: 10.1111/sms.14756.
PMID: 39508366DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz. Dr. Dr. med.
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
May 25, 2022
Primary Completion
January 1, 2023
Study Completion
January 18, 2023
Last Updated
October 16, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share