Activity and heart rate band validation Activity and heart rate watch energy expenditure algorithm validation

Completed

• Conditions: prevention of non-communicable lifestyle-related chronic disease such as cardiovascular disease or diabetes type 2; sedentary behaviour; sub-optimal physical fitness; 10082206; 10003018

• Registration Number: NL-OMON45332
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Validation of the activity and heart rate band:<br /><br>The primary objective of this part of the study is to determine the measurement<br /><br>accuracy of the activity and heart rate band with regards to medical parameter<br /><br>accuracy of total energy expenditure (TEE) estimation and resting heart rate<br /><br>(RHR) estimation.<br /><br><br /><br>Validation of the activity and heart rate watch EE algorithm:<br /><br>The objective of this part of the study is to validate that a firmware update<br /><br>17.1.0 for the activity and heart rate monitor has equivalent performance to<br /><br>the current firmware with regards to medical parameter accuracy of total energy<br /><br>expenditure estimation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Validation of the activity and heart rate band:<br /><br>Secondary objectives include exploratory assessment of accuracy of other<br /><br>measures of the band like step counting, activity recognition, actives minutes,<br /><br>respiration rate at rest and feedback on sleep duration, heart rate recovery,<br /><br>interbeat interval (IBI) measurement and VO2max estimation. </p><br>