Development of Artefact Removal and Physical Activity Algorithm

NCT05901038 | Completed

• 1 other identifier: ARTEPHYSICAL / EC 5241
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Exercise; Fitness Tracker; Heart Rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Validation artefact removal procedure

  During the entire duration of the study, on average 13 weeks

• Satisfaction heart rate monitors

  At study completion, on average after 13 weeks

Study Arms (3)

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

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

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

Interventions

Wearing heart rate monitors DEVICE

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

Cardiac patients (group 1); Coached sporters with 12-week training schedule (group 2); Sporters without 12-week training schedule (group 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hein Heidbuchel

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 13, 2023
• Study Start: February 24, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2026

Record last verified: 2025-03

Locations

BE (1)