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ACTIVE NOT RECRUITING
NCT05901038

Development of Artefact Removal and Physical Activity Algorithm

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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, i.e. 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 (e.g. 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.

Official title: Development of Artefact Removal and Physical Activity Algorithm for Continuous Activity Monitoring by Heart Rate Monitors in Cardiac Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

138

Start Date

2023-02-24

Completion Date

2025-09-01

Last Updated

2025-09-10

Healthy Volunteers

Yes

Interventions

DEVICE

Wearing heart rate monitors

Participants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker.

Locations (1)

University Hospital Antwerp

Edegem, Antwerp, Belgium