By InvitationNot Applicable

Exercise Prescription in Cardiac Rehabilitation Mediated by Autonomic Function

Portugal90 participantsStarted 2024-01-02

Plain-language summary

Cardiac rehabilitation (CR) is an essential secondary prevention component in the treatment of cardiovascular diseases and one of the most cost- effective clinical interventions. Exercise training (ET) in CR programs (CRP) has unequivocal benefits in the reduction of cardiovascular adverse events, by decreasing the overactivated sympathetic tone. This ET added value can be measured by variables that express autonomic control using indirect (standard) or direct (experimental) methodologies. Direct autonomic assessment (ex. Microneurography) is accurate but unusable in daily practice, whereas standard indirect autonomic assessment using clinical parameters is imprecise, resulting in underprescription to safeguard patient safety, with less benefit to the patients. In this project, we aim to apply Machine Learning models to a set of indirect and direct variables, to make a multivariate correlation analysis and so define a normalization factor for exercise prescription.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with Coronary artery disease and no heart failure criteria * Patients with non ischaemic heart failure and reduced left ventricle ejection fraction Exclusion Criteria: * patients with ongoing acute coronary syndrome * patients with ongoing acute decompensated heart failure * Severe valvular heart disease that might confound the relationship between exercise and autonomic function. * Severe arrhythmias (e.g., sustained ventricular tachycardia, atrial fibrillation with a rapid ventricular rate) that are symptomatic or untreated * Severe uncontrolled hypertension (e.g., systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg) * Active infectious diseases or other significant acute medical illnesses (e.g., sepsis, active malignancy, acute kidney injury) * Pregnancy or lactation (to ensure safety during exercise interventions) * Significant cognitive impairment or mental illness (e.g., dementia, schizophrenia) that would impair the ability to follow exercise protocols or understand study instructions * nability to comply with study procedures due to any reason (e.g., language barriers, lack of informed consent) * Chronically immunocompromised states (e.g., HIV with CD4 count \< 200 cells/µL or on immunosuppressive therapy) * Presence of significant comorbidities such as advanced chronic obstructive pulmonary disease (COPD), kidney disease (e.g., stage 4-5 chronic kidney disease), or uncontrolled diabetes that would make exercise unsafe or confound the…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Normalization Factor for Sympathetic Activation Derived from Multimodal Autonomic Assessment

Timeframe: Baseline (before initiation of cardiac rehabilitation program)

Trial details

NCT IDNCT07288840

SponsorInstituto Politécnico de Leiria

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Cardiac Rehabilitation trials