Activity and heartrate monitor validation study

The purpose of the activity and heart rate monitor 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.

The primary objective of this study is to determine the accuracy of energy
expenditure and resting heart rate measurement.

Secondary objectives include assessment of accuracy of other measures like
sleep duration, steps counting, activity recognition, respiration rate at rest,
heart rate recovery, interburst interval and VO2max estimation. Last wear
comfort of the device will be evaluated.

The study follows a within-person paired measurement design. The study consists
of an intake, 3 days free lving monitoring, and measurement in a controlled
environment of +/- 2.5 hours. From the free-living measurements data will be
collected to estimate the resting heart rate, sleep duration measurements can
be validated, sedentary behavior detection buzz can be checked, and heart rate
recovery and VO2 max assessment can be checked. The controlled measurement is
used for the validation of the energy expenditure measurements and provides
reference data for resting heart rate. Both of these datacollections will also
be used for secondary purposes.

During the controlled measurements subjects are asked to complete various
activities (eg. Walking and cycling). During the measurements the activity and
heart rate monitor is worn and reference measurements are made.

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