Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05525000 |
| Other study ID # |
ValOpti |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2022 |
| Est. completion date |
January 18, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Ludwig Boltzmann Institute for Digital Health and Prevention |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 medical-grade ECG device as a criterion measure.
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.
