Development of Artefact Removal and Physical Activity Algorithm (ARTEPHYSICAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Heart Rate; Fitness Tracker
• Intervention / Treatment: Device: Wearing heart rate 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 (i.e. the gold standard indicator for determining exercise capacity).

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Paulien Vermunicht; Phone Number: 003238212195; Email: paulien.vermunicht@uantwerpen.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: Paulien Vermunicht; Phone Number: 003238212195; Email: paulien.vermunicht@uantwerpen.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Groups are selected from different populations: patients participating in a cardiac rehabilitation programme at the UZA (group 1), sporters attending a sports cardiology consultation at Sport Medical Centre Nottebohm (group 2) or sporters attending a sports medical check-up at S.P.O.R.T.S. (i.e., a multidisciplinary centre of expertise within UZA, group 3).

Description

Inclusion Criteria:

1. Age ≥ 18 years,
2. 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,
3. Having a smartphone available,
4. Being capable of signing the informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac patients (group 1); Patients with prior myocardial infarction, percutaneous coronary intervention (PCI), cardiac ablation or cardiac surgery, attending a reimbursed cardiac rehabilitation programme in the cardiology department of the UZA.	Device: Wearing heart rate monitors; Participants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker.
Coached sporters with 12-week training schedule (group 2); Sporters attending a sports cardiology consultation and following a 12-week training schedule at Sport Medical Centre Nottebohm.	Device: Wearing heart rate monitors; Participants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker.
Sporters without 12-week training schedule (group 3); Sporters attending a sport medical check-up at S.P.O.R.T.S. (i.e., a multidisciplinary centre of expertise within UZA), but without standardized 12-week training schedule.	Device: Wearing heart rate monitors; Participants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A physical activity algorithm with accompanying score	The primary outcome of this study is an algorithm and associated score that quantifies day-to-day physical activity.	During the entire duration of the study, on average 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation artefact removal procedure	The accuracy, sensitivity and specificity of the artefact removal procedure will be evaluated.	During the entire duration of the study, on average 13 weeks
Satisfaction heart rate monitors	We will evaluate how participants perceive wearing heart rate monitors for long periods of time using self-developed questionnaires.	At study completion, on average after 13 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Universiteit Antwerpen
• Investigators: Principal Investigator: Hein Heidbuchel, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Estimated): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ARTEPHYSICAL / EC 5241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No