Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05901038
Status:
RECRUITING
Last Update Posted:
2023-06-13
First Post:
2023-05-02
Brief Title:
Development of Artefact Removal and Physical Activity Algorithm
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Development of Artefact Removal and Physical Activity Algorithm for Continuous Activity Monitoring by Heart Rate Monitors in Cardiac Patients
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEPHYSICAL
Brief Summary:
This clinical trial will collect heart rate HR data with the Fitbit Inspire 2 fitness tracker and Polar H10 chest strap with the aim of
Goal 1 Optimising and validating our artefact removal procedure
Goal 2 Developing a physical activity PA algorithm to follow and quantify day-to-day PA based on HR measurements
A pilot study will be conducted with a total of 46 cardiac patients group 1 46 coached sporters with 12-week training schedule group 2 and 46 sporters without 12-week training schedule group 3 The three groups all engage in controlled activities
The participants HR will be monitored continuously for an average period of 13 weeks using 2 HR monitors ie the Fitbit Inspire 2 fitness tracker and the Polar H10 chest strap They will wear the Fitbit device continuously for the whole monitoring period while they will wear the Polar chest strap continuously for the first 24 hours and after that only during exercise
To determine participants exercise capacity eg VO2max cardiopulmonary exercise tests CPETS will be carried out For group 1 3 CPETS will take place during the CR programme at the start in the middle and at the end For group 2 and group 3 2 CPETS will be carried out at the start and the end of the study The monitoring period with Fitbit and Polar will end at the last CPET
All participants will record their daily efforts in an activity diary during the first week of study Moreover two questionnaires will be conducted at the end of the study to evaluates usability and experiences with the HR monitors
Goal 1 Optimising and validating our artefact removal procedure
Goal 2 Developing a physical activity PA algorithm to follow and quantify day-to-day PA based on HR measurements
A pilot study will be conducted with a total of 46 cardiac patients group 1 46 coached sporters with 12-week training schedule group 2 and 46 sporters without 12-week training schedule group 3 The three groups all engage in controlled activities
The participants HR will be monitored continuously for an average period of 13 weeks using 2 HR monitors ie the Fitbit Inspire 2 fitness tracker and the Polar H10 chest strap They will wear the Fitbit device continuously for the whole monitoring period while they will wear the Polar chest strap continuously for the first 24 hours and after that only during exercise
To determine participants exercise capacity eg VO2max cardiopulmonary exercise tests CPETS will be carried out For group 1 3 CPETS will take place during the CR programme at the start in the middle and at the end For group 2 and group 3 2 CPETS will be carried out at the start and the end of the study The monitoring period with Fitbit and Polar will end at the last CPET
All participants will record their daily efforts in an activity diary during the first week of study Moreover two questionnaires will be conducted at the end of the study to evaluates usability and experiences with the HR monitors
Detailed Description:
Sufficient physical activity PA is becoming more and more important in the prevention onset and treatment of several cardiovascular diseases Heart rate HR monitors are of interest to researchers and various healthcare providers because of their ability to use HR to indicate PA levels of individual cardiac patients in an objective accurate and continuous way
However artefacts such as over- and underestimation may affect the accuracy of these HR monitors in daily living conditions of specific cardio populations Moreover reliable parameters and algorithms to objectively map calculate and monitor PA are still lacking
The research group has been able to improve the accuracy of HR monitors by detecting and correcting artefacts and is further exploring the technical possibilities of developing an artefact removal procedure aiming for an improved and automatic way to continuously monitor HR in cardiac patients However more data is needed to optimise and validate the procedure In addition more HR data of controlled activities are needed because the investigators aim to develop an innovative PA algorithm that calculates a daily score to quantify PA levels based on HR measurements and focused on the prediction of VO2max data ie the gold standard indicator for determining exercise capacity
However artefacts such as over- and underestimation may affect the accuracy of these HR monitors in daily living conditions of specific cardio populations Moreover reliable parameters and algorithms to objectively map calculate and monitor PA are still lacking
The research group has been able to improve the accuracy of HR monitors by detecting and correcting artefacts and is further exploring the technical possibilities of developing an artefact removal procedure aiming for an improved and automatic way to continuously monitor HR in cardiac patients However more data is needed to optimise and validate the procedure In addition more HR data of controlled activities are needed because the investigators aim to develop an innovative PA algorithm that calculates a daily score to quantify PA levels based on HR measurements and focused on the prediction of VO2max data ie the gold standard indicator for determining exercise capacity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None