Cardiac RehabilitationExercise TherapyAutonomic Nervous System ImbalanceTreatment Outcomes
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 study outcomes
* Critical limb ischemia, or severely symptomatic peripheral artery disease or claudication limiting functional capacity and response to exercise
* Advanced chronic kidney disease (stage 4 or 5), due to contraindications with exercise
* Severe anemia (hemoglobin \< 8 g/dL) or other blood disorders that affect exercise capacity
* Inability to tolerate exercise due to other comorbidities or debility
* individuals with known autonomic neuropathy (such as poorly controlled diabetes or neurodegenerative disorders)
Specific Exclusion Criteria for Coronary Artery Disease (CAD) without Heart Failure Group:
* Left ventricular ejection fraction (LVEF) \< 50%
* Clinical/echocardiographic criteria of heart failure with oreserved ejection fraction.
Specific Exclusion Criteria for Non-Ischemic Heart Failure with Reduced LVEF Group:
* Ischemic heart disease or previous myocardial infarction
* LVEF \> 40%
* End-stage heart failure (e.g., patients on a heart transplant list, those with imminent need for mechanical circulatory support like LVAD).
* Severe fluid overload that cannot be corrected
Primary outcome measure(s)
Normalization Factor for Sympathetic Activation Derived from Multimodal Autonomic Assessment — Baseline (before initiation of cardiac rehabilitation program) A composite autonomic normalization factor will be generated using Principal Component Analysis (PCA) applied to multimodal autonomic and metabolic biomarkers (including microneurography-derived MSNA, heart rate variability indices from 24-hour Holter, CPET first-minute heart rate recovery, and serum/urinary catecholamines). This factor will quantify the individual degree of sympathetic activation and will serve as the basis for personalized exercise training prescription (Units of mesaure: unitless)
Trial sites (2)
Facility
City
Region
Status
ciTechCare - Center for Innovative Care and Health Technology
Leiria
Leiria District
ICVS - Life and Health Sciences Research Institute, Minho University Medical School
Braga
Minho
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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