ExerciseARTEPHYSICALNCT05901038
Development of Artefact Removal and Physical Activity Algorithm
An observational study of Exercise and Fitness Tracker, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise, Fitness Tracker, Heart Rate
- What is being tested?
- Wearing heart rate monitors
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Feb 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients with severe heart failure (NYHA III-IV),
- Not able to speak and read Dutch or English,
- Cognitive impaired (e.g. severe dementia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Exercise, Fitness Tracker, Heart Rate
- Being tested
- Wearing heart rate monitors
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing heart rate monitorsDevice
Participants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Wearing heart rate monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the entire duration of the study, on average 13 weeks
Secondary outcomes (2)
Validation artefact removal procedure
The accuracy, sensitivity and specificity of the artefact removal procedure will be evaluated.
Measured: 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.
Measured: At study completion, on average after 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start24 Feb 2023
- Primary completion1 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Hein Heidbuchel, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901038
- Sponsor's protocol ID
- ARTEPHYSICAL / EC 5241
- Acronym
- ARTEPHYSICAL
- Status last verified
- Mar 2025
- First submitted
- 2 May 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Artefact Removal and Physical Activity Algorithm for Continuous Activity Monitoring by Heart Rate Monitors in Cardiac Patients
- ClinicalTrials.gov ID
- NCT05901038
- Acronym / sponsor ID
- ARTEPHYSICAL / ARTEPHYSICAL / EC 5241
- Conditions
- Exercise, Fitness Tracker, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac patients (group 1) | – | Device: Wearing heart rate monitorsPatients 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. |
| Coached sporters with 12-week training schedule (group 2) | – | Device: Wearing heart rate monitorsSporters attending a sports cardiology consultation and following a 12-week training schedule at Sport Medical Centre Nottebohm. |
| Sporters without 12-week training schedule (group 3) | – | Device: Wearing heart rate monitorsSporters 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with severe heart failure (NYHA III-IV),
- Not able to speak and read Dutch or English,
- Cognitive impaired (e.g. severe dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing heart rate monitorsParticipants will use 2 consumer wearable heart rate monitors: Polar H10 chest strap and Fitbit Inspire 2 fitness tracker. | Device | Cardiac patients (group 1), Coached sporters with 12-week training schedule (group 2), Sporters without 12-week training schedule (group 3) |
Primary outcome
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.
2 secondary outcomes
Validation artefact removal procedure
Time frame: During the entire duration of the study, on average 13 weeks
Satisfaction heart rate monitors
Time frame: At study completion, on average after 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hein Heidbuchel principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Fitness Tracker, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A physical activity algorithm with accompanying score (time frame: During the entire duration of the study, on average 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.