Monitoring and Guidance of Physical Activity During the Maintenance Phase of Cardiac Rehabilitation: the Antwerp Activity Index

NCT07211282 | Recruiting

• 2 other identifiers: BUN3002025000061G084023N
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to determine whether the AAI activity score can help cardiac rehabilitation patients adhere to physical activity guidelines after participating in an in-hospital cardiac rehabilitation program. The main questions it aims to answer are:

• Wear a smartwatch to continuously measure heart rate for 4 months;
• Perform an exercise stress test at the end of the study;
• Fill in several questionnaires at the end of the study.

Conditions

Cardiac Rehabilitation; Cardiovascular Disease Prevention

Keywords

physical activity; cardiac rehabilitation; heart rate monitor

Outcome Measures

Primary Outcomes (2)

• Objective moderate-to-vigorous physical activity performance adherence

  The primary aim of this study is to assess the impact of using the developed AAI score on adherence to moderate-to-vigorous pysical activity (MVA) during phase 3 CR. This will be objectively measured and analysed by calculating the number of minutes per week a participant spends above the threshold for moderate-to-vigorous physical activity, determined using individualised heart rate zones derived from cardiopulmonary exercise testing (CPET). Continuous heart rate data (collected using the Fitbit device) are used to calculate total MVPA minutes per week.

  From enrollment to the end of treatment at 4 months

• Subjective moderate-to-vigorous physical activity performance adherence

  At the end of the study, during the final study visit, researchers will question participants on their PA over the last 14 days using the International Physical Activity Questionnaire (IPAQ), a validated instrument for measuring short-term PA behaviour. The responses are used to calculate an activity level in Metabolic Equivalent of Task (MET)-minutes per week.

  From enrollment to the end of treatment at 4 months

Secondary Outcomes (4)

• Difference in MET-minutes/week in objectively measured physical activity and subjectively reported physical activity.

  From enrollment to the end of treatment at 4 months.

• Correlation between adherence to AAI score and cardiorespiratory fitness changes, as measured by VO2peak.

  from entrollment to the end of treatment at 4 months.

• Percentage of days participants adhere to AAI score target.

  From enrollment to the end of treatment at 4 months.

• Activity score influence on AF burden and recurrence.

  From enrollment to the end of treatment at 4 months.

Other Outcomes (1)

• Up/down time of the activity score system and application.

  From enrollment to the end of treatment at 4 months.

Study Arms (2)

AAI usage through personalised target

EXPERIMENTAL

Participants are instructed to continuously wear a Fitbit Versa 4 smartwatch for the whole monitoring period, sync the data daily via the Fitbit application, and charge the device when needed. The intervention group has access to the generated AAI scores through a study application. During an initiation visit, they will be informed about how the score works and its purpose. They will receive tailored targets to adhere to. This group will also receive semi-automatic feedback reports through the study application. Feedback will be provided every two weeks for the first two months and once more at the end of the third month. No feedback will be given during the last month of follow-up.

Device: Activity score

Blinded AAI data collection

NO INTERVENTION

Participants are instructed to continuously wear a Fitbit Versa 4 smartwatch for the whole monitoring period, sync the data daily via the Fitbit application, and charge the device when needed. They can use the device to their liking. They do not have access to the AAI algorithm, nor will they receive feedback through the study application.

Interventions

Activity score DEVICE

4 month follow-up and feedback from a heart rate and personal characteristics based activity score.

AAI usage through personalised target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years,
• Patients in the last phase of phase 2 CR,
• Having a smartphone available,
• Being capable of signing the informed consent.

You may not qualify if:

• Patients with high-risk criteria for safe exercise participation following a cardiac event, including:
• Ejection fraction less than 30%
• Decrease in systolic blood pressure of more than 15 mmHg with exercise
• Serious arrhythmias at rest or exercise-induced
• Exercise-induced ischemia indicated by angina more than 2 mm ST segment depression on the ECG
• Patients with severe heart failure (NYHA III-IV),
• Patients with implantable devices (e.g. pacemakers),
• Patients diagnosed with permanent AF,
• Patients who do not speak and read Dutch or English,
• Patients who have cognitive impairment (e.g. severe dementia).

Sponsors & Collaborators

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

Study Sites (2)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Jessa Hospital Hasselt

Hasselt, Limburg, 3500, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hein Heidbuchel

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Buyck

CONTACT

+32 3 821 42 03; christophe.buyck@uantwerpen.be

Lien Desteghe

CONTACT

+32 821 33 06; lien.desteghe@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 7, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)