The primary objective of this study is to determine the equivalence accuracy of energy expenditure and resting heart rate measurement of newly developed software in reference to currently approved software. Secondary objective is to asses the…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters of the study are the accuracy of energy expenditure and
resting heart rate measurement of newly developed software in reference to
currently approved software.
Secondary outcome
Secondary parameter is to asses the measurement accuracy of newly developed
software in reference to currently approved software over 10 second averaged
values.
Background summary
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.Currently, the
activity and heart rate monitor has been approved as a medical device. However,
we have developed new software that can prevent errors in the heart rate
measurement. It must now be shown that the accuracy of the new software is
similar to the previously approved software.
Study objective
The primary objective of this study is to determine the equivalence accuracy of
energy expenditure and resting heart rate measurement of newly developed
software in reference to currently approved software. Secondary objective is to
asses the measurement accuracy of newly developed software in reference to
currently approved software over 10 second averaged values.
Study design
The study follows a randomised within-person paired measurement design. The
study consists of a measurement in a controlled environment of +/- 2.5 hours.
The controlled measurement is used for the validation of the energy expenditure
measurements and for resting heart rate.
Intervention
During the controlled measurements subjects are asked to complete various
activities (eg. Walking and cycling). During the measurements two activity and
heart rate monitors are worn, one with newly developed software and one with
the currently approved software.
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 or spraining during the protocol because we ask
participants to exercise. Risks are 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 data storage 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
-18 years of age or older
-Body Mass Index (BMI) between 19 and 35
Exclusion criteria
- Suffer from severe chronic disease for which a physician has contraindicated moderate intensity exercise without medical supervision.
- Function/mobility and or cognitive impairments preventing compliance with the study protocol
- Having pacemaker or other implantable electronic devices
- Skin issues or wounds in wrist area
- Might be or is pregnant
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 | NL59416.028.16 |
| OMON | NL-OMON29620 |