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Completed

NCT Number: NCT05901038

Development of Artefact Removal and Physical Activity Algorithm

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.

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Key information

Conditions

Exercise Behavior Fitness Tracker Heart Rate Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

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 (i.e. the gold standard indicator for determining exercise capacity).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years,
  • Patients participating in the CR programme with a prior myocardial infarction without impairment of pump function, percutaneous coronary intervention (PCI), cardiac ablation or cardiac surgery, OR Sporters attending a sports cardiology consultation and following a 12-week training schedule at Sport Medical Centre Nottebohm, OR Sporters attending a sport medical check-up at S.P.O.R.T.S. who do not follow a 12-week training schedule,
  • Having a smartphone available,
  • Being capable of signing the informed consent.

Exclusion criteria

  • Patients with severe heart failure (NYHA III-IV),
  • Not able to speak and read Dutch or English,
  • Cognitive impaired (e.g. severe dementia).

Treatment and study plan

Wearing heart rate monitors

Device

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

Primary outcomes

  1. A physical activity algorithm with accompanying score

    Time frame: During the entire duration of the study, on average 13 weeks

    The primary outcome of this study is an algorithm and associated score that quantifies day-to-day physical activity.

Secondary outcomes

  1. Validation artefact removal procedure

    Time frame: During the entire duration of the study, on average 13 weeks

    The accuracy, sensitivity and specificity of the artefact removal procedure will be evaluated.

  2. Satisfaction heart rate monitors

    Time frame: At study completion, on average after 13 weeks

    We will evaluate how participants perceive wearing heart rate monitors for long periods of time using self-developed questionnaires.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

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

Acronym: ARTEPHYSICAL

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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