Using the Antwerp Activity Index to guide physical activity after cardiac rehabilitation
Transmural Physical Activity Monitoring and Guidance During Phase 3 Cardiac Rehabilitation: the Antwerp Activity Index
We will try whether wearing a smartwatch and using the Antwerp Activity Index (AAI) helps people who finished in-hospital cardiac rehab stick to recommended physical activity and improve fitness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 2 sites (Edegem, Antwerp and 1 other locations) |
| Trial ID | NCT07211282 on ClinicalTrials.gov |
What this trial studies
Participants will wear a Fitbit Versa 4 and a Polar H10 chest strap to collect continuous heart rate data for four months while an AAI activity score is calculated from those data. People will be assigned to receive AAI score feedback or usual care and the groups will be compared for adherence to physical activity recommendations and changes in cardiorespiratory fitness. At the end of follow-up participants will complete questionnaires and perform an exercise stress test to measure fitness. The trial will also compare self-reported versus objectively measured activity and include a subanalysis in a subgroup with atrial fibrillation.
Who should consider this trial
Good fit: Adults who have just completed the in-hospital phase of phase 2 cardiac rehabilitation, have a smartphone, and can give informed consent are suitable candidates.
Not a fit: Patients with high exercise risk (for example severe heart failure, very low ejection fraction), permanent atrial fibrillation, implantable cardiac devices, or who cannot read Dutch or English are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could help patients maintain regular exercise after cardiac rehab and preserve or improve their cardiorespiratory fitness.
How similar studies have performed: Other trials using wearable heart-rate monitors and feedback have shown modest and sometimes mixed improvements in exercise adherence in cardiac populations, while the specific AAI scoring approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years, 2. Patients in the last phase of phase 2 CR, 3. Having a smartphone available, 4. Being capable of signing the informed consent. Exclusion Criteria: 1. Patients with high-risk criteria for safe exercise participation following a cardiac event, including: 1. Ejection fraction less than 30% 2. Decrease in systolic blood pressure of more than 15 mmHg with exercise 3. Serious arrhythmias at rest or exercise-induced 4. Exercise-induced ischemia indicated by angina more than 2 mm ST segment depression on the ECG 2. Patients with severe heart failure (NYHA III-IV), 3. Patients with implantable devices (e.g. pacemakers), 4. Patients diagnosed with permanent AF, 5. Patients who do not speak and read Dutch or English, 6. Patients who have cognitive impairment (e.g. severe dementia).
Where this trial is running
Edegem, Antwerp and 1 other locations
- University Hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
- Jessa Hospital Hasselt — Hasselt, Limburg, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Hein Heidbuchel — University Hospital, Antwerp
- Study coordinator: Christophe Buyck
- Email: christophe.buyck@uantwerpen.be
- Phone: +32 3 821 42 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.