The purpose of the study is to validate the measurements of an activity and heart rate band. The primary objective of this study is to determine the measurement accuracy of the activity and heart rate band with regards to the measurement of energy…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
- Appetite and general nutritional disorders
Synonym
Health condition
prevention of non-communicable lifestyle-related chronic disease such as cardiovascular disease or diabetes type 2
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of the activity and heart rate band:
The primary objective of this part of the study is to determine the measurement
accuracy of the activity and heart rate band with regards to medical parameter
accuracy of total energy expenditure (TEE) estimation and resting heart rate
(RHR) estimation.
Validation of the activity and heart rate watch EE algorithm:
The objective of this part of the study is to validate that a firmware update
17.1.0 for the activity and heart rate monitor has equivalent performance to
the current firmware with regards to medical parameter accuracy of total energy
expenditure estimation.
Secondary outcome
Validation of the activity and heart rate band:
Secondary objectives include exploratory assessment of accuracy of other
measures of the band like step counting, activity recognition, actives minutes,
respiration rate at rest and feedback on sleep duration, heart rate recovery,
interbeat interval (IBI) measurement and VO2max estimation.
Background summary
The purpose of the activity and heart rate band / watch is to measure and track
movement (acceleration) and heartbeat, and derive a number of health-related
parameters, which can serve as basis for behavioral change programs leading to
e.g. a healthier, more active lifestyle, weight reduction, reduced risk of
cardio-vascular disease, reduced risk of diabetes, or can be part of a disease
or condition management program. In order for such a measurement/monitoring
device to be able to lead to positive health benefits a preliminary requirement
is that it measures the basic parameters in an accurate manner.
Study objective
The purpose of the study is to validate the measurements of an activity and
heart rate band. The primary objective of this study is to determine the
measurement accuracy of the activity and heart rate band with regards to the
measurement of energy expenditure and resting heart rate. Secondary objectives
include assessment of accuracy of other measures of the monitor like steps
counting, activity recognition, respiration rate at rest, and feedback on sleep
duration, heart rate recovery, interbeat interval (IBI) measurement and VO2max
estimation.
Furthermore, it is the purpose of this study to validate a firmware update of
the activity and heart rate watch, with respect to the accuracy of the energy
expenditure estimate.
Study design
Within-person paired comparison study design
Intervention
Part 1: Intake and informed consent. The activity and heart rate band is taken
home.
Part 2: 3 days of free living while subject wears the band day and night.
Part 3: Lab test with rest-activity protocol. Subjects wear the activity and
heart rate band and the activity and heart rate monitor.
Duration of individual subject participation: 3 days of free-living monitoring
and a laboratory session of approx. 2.5 hours
Study burden and risks
Anticipated clinical benefits:
In the future the device will be used with programs users will have a clinical
benefit, we are now testing the accuracy of the
measurement device.
Anticipated adverse device effects:
Not expected
Residual risks associated with investigational device:
Possibly contact allergy (skin redness, irritation) or skin irritation due to
prolonged wearing.
Risks associated with participation in clinical investigation:
Minimal risks. There is risk on falling during the protocol because we ask
participants to exercise. Risks is mitigated
because of the use of good research and sporting materials and continuous
observation by researchers. Privacy risk are
mitigated by separating the personal data from the research data and
datastorage in a secured database by an external,
certified clinical research organisation.
Possible interactions with concomitant medical treatments:
There are no interactions with concomitant medical treatments
Steps that will be taken to control or mitigate risks:
Information on the device will be given to the participants before start of the
study
High Tech Campus 37
Eindhoven 5656AE
NL
High Tech Campus 37
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
- Aged greater or equal to 35 years old
- Body mass index [body weight (kilograms)] / [height^2 (meters)] between 19 and 35 kg /m2;Any of the following risk factors:
- Age.
- A family history of cardiovascular disease or diabetes type 2.
- Smoking.
- Overweight / obesity.
- Elevated blood cholesterol.
- Elevated blood pressure.
- Manifest diabetes type 2.
Exclusion criteria
- Suffer from severe chronic disease for which a physician has contraindicated moderate intensity exercise without medical supervision. Subjects will be asked to fill in the Physical Activity Readiness questionnaire (PAR-Q (15-17)) during recruitment and also at intake.
o Subjects who answered *yes* to any of the items of the PAR-Q during recruitment will be asked to provide a written statement by their physician that they can safely undergo moderate-intensity exercise without medical supervision as foreseen by this protocol.
- Function/mobility and/or cognitive impairments preventing compliance with the study protocol
- Having a pacemaker or other implantable electronic devices
- Skin issues or wounds in wrist area
- Might be or is pregnant (self-report)
- Has a beard (because of the risk of having non-removable hairs in the mask of the K5 system that could compromise functioning)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60348.028.16 |
| OMON | NL-OMON25339 |