Health Care UtilizationValOptiNCT05525000
Validity and Reliability of Optical Heart Rate Sensors
A study testing Validation in people with Health Care Utilization, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Validation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 25 May 2022to 18 Jan 2023
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 35 and 80 years
- All sexes
- Able to perform physical activity according to the study protocol
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsinstitut für präventive und rehabilitative Sportmedizin
Salzburg, 5020
About this study
Official title: Validity and Reliability of Consumer-Grade Optical Heart Rate Sensors to Assess Volume of Physical Activity and to Categorize Its Intensity
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.
Read the detailed description
Candidate consumer-grade wearables are selected according to available data from manufacturers, available scientific literature and our team's own practical experience.
First, a mobile 12-lead ECG (Amedtec ECGpro, Aue, Germany) device is placed on the participant according to recommendations of medical societies and the manufacturer's instructions. Additionally, the participant wears four optical heart rate devices simultaneously. Each device will be placed according to the manufacturer's instructions, The devices will be randomly applied on the dominant or non-dominant wrist and to the dominant and non-dominant arm, respectively. All participants will be handed an instruction sheet and video how to place each device in case it is displaced and how to check that data collection is working.
The 13-min laboratory protocol will be performed in keeping with an expert statement of the INTERLIVE Network and starts with a session mimicking lifestyle activity that consists of: 1 minute of quiet sitting, 2 minutes of upper body activities, 1 minute of quiet sitting, 30 seconds of transition to treadmill, 2 minutes of walking at self-selected speed, 30 seconds of transition to chair, 2 minutes of seated typing, 30 seconds of transition, 2 minutes of full body daily living activities including vacuum cleaning and ironing, and 1 minute of quiet sitting.
After completion of the lifestyle activities test, participants proceed with the treadmill step test. The treadmill step test protocol starts with 1 minute of quiet standing, 3 minutes of (4 km/h), 30 seconds of rest, 3 minutes of running (6 km/h) and an increment of 2 km/h at each stage with 30 seconds of rest between each stage until volitional exhaustion. Capillary blood samples will be taken from the earlobe to assess blood lactate concentration after each stage of the exercise test. Dependent on physical fitness 3 to 8 blood lactate samples will be taken. A breath-by-breath spiroergometry device will measure gas exchange, ventilation and maximal oxygen uptake during the exercise test using a metabolic analyzer. After termination of the exercise test subjective exhaustion will be assessed by the BORG scale. The 12-lead ECG will allow ruling out clinically relevant coronary artery disease and/or arrhythmias, and identify maximum heart rates from which intensity zones will be derived. Test termination will be followed by a 5-min cool down period at walking speed (3 km/h) on the treadmill. Throughout the treadmill test the participant is secured with a safety belt to prevent any injuries in case of falling.
Directly after the 5-min cool down, exercise testing on the cycle ergometer starts, beginning with 1 minute of quiet sitting. Then load is increased until the participant exercises at low intensity (57-63% of maximum heart rate obtained in the treadmill test) which will be maintained for at least 2 minutes, followed by 1 minute of rest, 2 minutes of moderate intensity (64-76% of maximum heart rate), 1 minute of rest, 2 minutes of vigorous intensity (>77% of maximum heart rate) followed by 1 minute of cool-down. All activity intensity zones are defined according to medical guidelines.
For the free-living part the electrodes of an ambulatory 3-lead-ECG (Amedtec ECGpro, Aue, Germany) are placed according to the manufacturer's instructions. Additionally, the participant wears four optical heart rate devices simultaneously.
The measurement of all devices starts simultaneously between 8:00 and 11:00 a.m. and is recorded for 24 hours. The only instruction the participants get are to walk for six minutes on a flat terrain as fast as possible once in the afternoon. At the end of the 24-hour period, participants stop all optical heart rate devices and return the devices to the University Institute of Sports Medicine, Prevention and Rehabilitation. There, the lifestyle activities and cycle ergometry laboratory testing protocol of day 1 will be repeated for reliability assessment. Finally, participants will be asked to fill out the IDEA-Fast Technology Experience Questionnaire (ITEQ) questionnaire to obtain information on the usability of the devices.
The 3-lead Holter-ECG will be analyzed by a licensed cardiologist for relevant arrhythmias.
- Conditions
- Health Care Utilization
- Being tested
- Validation
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValidationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Participants aged over 35 | Experimental | Participants run through our validation protocol Receives: Device: Validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate is measured with different devices and ECG while performing different activities and free living
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start25 May 2022
- Primary completion1 Jan 2023
- Study completion18 Jan 2023
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 Health Care UtilizationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Responsible party
- Principal investigator, Mahdi Sareban, Salzburger Landeskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525000
- Sponsor's protocol ID
- ValOpti
- Acronym
- ValOpti
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39508366
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Consumer-Grade Optical Heart Rate Sensors to Assess Volume of Physical Activity and to Categorize Its Intensity
- ClinicalTrials.gov ID
- NCT05525000
- Acronym / sponsor ID
- ValOpti / ValOpti
- Conditions
- Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Collaborators
- Salzburger Landeskliniken
- Study start
- 25 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 1 Sep 2022 (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.
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.
Detailed description
Candidate consumer-grade wearables are selected according to available data from manufacturers, available scientific literature and our team's own practical experience.
First, a mobile 12-lead ECG (Amedtec ECGpro, Aue, Germany) device is placed on the participant according to recommendations of medical societies and the manufacturer's instructions. Additionally, the participant wears four optical heart rate devices simultaneously. Each device will be placed according to the manufacturer's instructions, The devices will be randomly applied on the dominant or non-dominant wrist and to the dominant and non-dominant arm, respectively. All participants will be handed an instruction sheet and video how to place each device in case it is displaced and how to check that data collection is working.
The 13-min laboratory protocol will be performed in keeping with an expert statement of the INTERLIVE Network and starts with a session mimicking lifestyle activity that consists of: 1 minute of quiet sitting, 2 minutes of upper body activities, 1 minute of quiet sitting, 30 seconds of transition to treadmill, 2 minutes of walking at self-selected speed, 30 seconds of transition to chair, 2 minutes of seated typing, 30 seconds of transition, 2 minutes of full body daily living activities including vacuum cleaning and ironing, and 1 minute of quiet sitting.
After completion of the lifestyle activities test, participants proceed with the treadmill step test. The treadmill step test protocol starts with 1 minute of quiet standing, 3 minutes of (4 km/h), 30 seconds of rest, 3 minutes of running (6 km/h) and an increment of 2 km/h at each stage with 30 seconds of rest between each stage until volitional exhaustion. Capillary blood samples will be taken from the earlobe to assess blood lactate concentration after each stage of the exercise test. Dependent on physical fitness 3 to 8 blood lactate samples will be taken. A breath-by-breath spiroergometry device will measure gas exchange, ventilation and maximal oxygen uptake during the exercise test using a metabolic analyzer. After termination of the exercise test subjective exhaustion will be assessed by the BORG scale. The 12-lead ECG will allow ruling out clinically relevant coronary artery disease and/or arrhythmias, and identify maximum heart rates from which intensity zones will be derived. Test termination will be followed by a 5-min cool down period at walking speed (3 km/h) on the treadmill. Throughout the treadmill test the participant is secured with a safety belt to prevent any injuries in case of falling.
Directly after the 5-min cool down, exercise testing on the cycle ergometer starts, beginning with 1 minute of quiet sitting. Then load is increased until the participant exercises at low intensity (57-63% of maximum heart rate obtained in the treadmill test) which will be maintained for at least 2 minutes, followed by 1 minute of rest, 2 minutes of moderate intensity (64-76% of maximum heart rate), 1 minute of rest, 2 minutes of vigorous intensity (>77% of maximum heart rate) followed by 1 minute of cool-down. All activity intensity zones are defined according to medical guidelines.
For the free-living part the electrodes of an ambulatory 3-lead-ECG (Amedtec ECGpro, Aue, Germany) are placed according to the manufacturer's instructions. Additionally, the participant wears four optical heart rate devices simultaneously.
The measurement of all devices starts simultaneously between 8:00 and 11:00 a.m. and is recorded for 24 hours. The only instruction the participants get are to walk for six minutes on a flat terrain as fast as possible once in the afternoon. At the end of the 24-hour period, participants stop all optical heart rate devices and return the devices to the University Institute of Sports Medicine, Prevention and Rehabilitation. There, the lifestyle activities and cycle ergometry laboratory testing protocol of day 1 will be repeated for reliability assessment. Finally, participants will be asked to fill out the IDEA-Fast Technology Experience Questionnaire (ITEQ) questionnaire to obtain information on the usability of the devices.
The 3-lead Holter-ECG will be analyzed by a licensed cardiologist for relevant arrhythmias.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants aged over 35 | Experimental | Device: ValidationParticipants run through our validation protocol |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 35 and 80 years
- All sexes
- Able to perform physical activity according to the study protocol
- Written informed consent
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| ValidationThe 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 | Device | Participants aged over 35 |
Primary outcome
Heart Rate
Time frame: 24 hours
Heart rate is measured with different devices and ECG while performing different activities and free living
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 16 Oct 2023.
- Derived from this study: PubMed 39508366Neudorfer 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation in people with Health Care Utilization, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
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 4 inclusion and 7 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 16 Oct 2023. 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 Austria. 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 (time frame: 24 hours). 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 NCT05525000, 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 16 Oct 2023.