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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

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:

1. Does the AAI activity score have an impact on adherence to physical activity maintenance during phase 3 CR? 2. Does the AAI activity score predict changes in cardiorespiratory fitness? Researchers will compare participants who use the AAI activity score with those who do not to determine if there are differences in physical activity adherence.

Participants will:

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years,

Patients in the last phase of phase 2 CR,

Having a smartphone available,

Being capable of signing the informed consent.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Activity score

    Device

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

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: AAI usage through personalised targetExperimental treatment 1 intervention
Group B: Blinded AAI data collectionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 4 months
2

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.

Time frame
From enrollment to the end of treatment at 4 months

Secondary outcomes

1

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

The researchers aim to analyse differences between self-reported (subjective) and objectively measured physical activity (PA) adherence, to provide a comprehensive overview of guideline adherence. For comparability, objectively measured data will be expressed in MET-minutes per week, calculated as the product of minutes spent in each intensity zone (moderate or vigorous) multiplied by the corresponding MET intensity as defined in the IPAQ scoring protocol.

Time frame
From enrollment to the end of treatment at 4 months.
2

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

The researchers investigate whether adherence to the AAI score, measured as the percentage of days the target is reached, correlates with changes in CRF, measured through VO2peak.

Time frame
from entrollment to the end of treatment at 4 months.
3

Percentage of days participants adhere to AAI score target.

To assess whether patients adhere to the instructions and goals set by the AAI application. The percentage of days participants adhere to the daily target score will be calculated.

Time frame
From enrollment to the end of treatment at 4 months.
4

Activity score influence on AF burden and recurrence.

The Fibricheck application will measure the burden of AF within a specific subset of patients diagnosed with AF through semi-continuous PPG measurements. This burden will be objectified as the proportion of measurements with AF in relation to the total number of measurements taken.

Time frame
From enrollment to the end of treatment at 4 months.

Other outcomes

1

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

System availability will be quantified as the proportion of time the application and algorithm were operational during the study period. Uptime percentage will be calculated as the total hours the system was available divided by the total hours in the observation period) × 100. Downtime will be reported as the cumulative duration (in hours or days) the system was not usable, expressed both in absolute terms and as a percentage of the total study period.

Time frame
From enrollment to the end of treatment at 4 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

Universiteit Antwerpen

Collaborator

Jessa Hospital

Collaborator