Exercise Prescription in Cardiac Rehabilitation Mediated by Autonomic Function
NCT ID: NCT07288840
Last Updated: 2025-12-17
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
90 participants
OBSERVATIONAL
2024-01-02
2026-12-31
Brief Summary
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Detailed Description
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After careful ponderation, two important but different pathologies with clearly demonstrated ASS overactivation were considered: "non- ischemic HF with reduced ejection fraction" (NIHFrEF) and "CAD without HF" (CADnonHF). The following secondary objectives contribute to the achievement of this central goal, and define the majority of the associated tasks:
* Evaluation of the basal sympathetic activation pattern in patients with NIHFrEF and CADnonHF (Task2);
* Definition of a normalization factor regarding sympathetic activation for ET prescription purposes in the context of CRPs (Task3)
* Definition of an exercise training program for CRPs with prescription guided by the autonomic response (Task 4); In Task 2 the basal activation level of the Autonomic nervous system (ANS) will be characterized for each of the two identified conditions (NIHFrEF and CADnonHF) using a sample of 30 patients for each one to ensure a good approximation of the sampling distribution of the mean using the central limit theorem, and the participants will be enrolled at the CR consultation in Centro Hospitalar de Leiria (CHL) Cardiology department. The CHL CR Unit is accreditated by the European Association of Preventive Cardiology (EAPC) since 2022. Classical indirect measures of ANS which are relatively imprecise, such as heart rate variability (HRV) and derived indexes will be obtained with a 24h Holter and a "long duration EKG", as well as the first minute HR recovery with a Cardiopulmonary Exercise Test (CPET) and also serum catecholamines in blood and urine samples. Besides these indirect measures, a direct recording of the SNS obtained by microneurography (MSNA) will be conducted, being available at the host research institution (ciTechCare). The set of variables (autonomic and its derivatives), together with the metabolic biomarkers, will allow a multivariate correlation analysis followed by the use of the Machine Learning algorithm "Principal Component analysis" (PCA) to reduce the dimensionality of the data set, and so define a normalization factor for exercise prescription purposes, which corresponds to the main goal associated with Task 3. This normalization factor will be key to establish the individual pattern of sympathetic activation, establishing the same starting point for initial prescription of exercise and an unbiased follow up of patient's performance. Regarding Task 4, training plans (aerobic/anaerobic load) will be carried out in conjunction with the levels defined for the classification model (one of the derivable of the previous Task), and will be developed by the candidate along with the Physiatrist of the CRP Team, by setting a combined (aerobic and resistance) and stratified (with various levels of intensity, frequency, stages and duration) training program. This protocol will be evaluated by the due health ethics committees (Task 1), and all legal issues regarding safety and data protection will be respected.
Regarding risks and strategies to mitigate them, the main risk is related to data assessment. In that case other hospitals may be contacted to increase the number of participants. Another risk is related to task dependency. In this case, the experience of the mentors and the integration of this project in a team with expertise in CRP and familiar with artificial intelligence applications in Medicine will be determinant.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with Coronary artery disease without Heart Failure (CADnonHF)
This group with clearly demonstrated Autonomic Simpathetic System overactivation will have a detailed evaluation of the autonomic nervous system by performing an echocardiogram, 24-hour Holter monitoring, cardiopulmonary exercise test, long-term electrocardiogram, microneurography, and serum and urinary determination of catecholamine levels
No interventions assigned to this group
Patients with non- ischemic Heart Failure with reduced ejection fraction (NIHFrEF)
This group, that also has clearly demonstrated Autonomic Simpathetic System overactivation, will, in the same way, have a detailed evaluation of the autonomic nervous system by performing an echocardiogram, 24-hour Holter monitoring, cardiopulmonary exercise test, long-term electrocardiogram, microneurography, and serum and urinary determination of catecholamine levels
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with non ischaemic heart failure and reduced left ventricle ejection fraction
Exclusion Criteria
* 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)
* Left ventricular ejection fraction (LVEF) \< 50%
* Clinical/echocardiographic criteria of heart failure with oreserved ejection fraction.
* 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
18 Years
ALL
No
Sponsors
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Universidade do Minho - ICVS
UNKNOWN
Hospital Santo André - Centro Hospitalar de Leiria
UNKNOWN
Fundação para a Ciência e a Tecnologia (FCT)
UNKNOWN
Instituto Politécnico de Leiria
OTHER
Responsible Party
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Alexandre Antunes
Medical Doctor (MD), Cardiologist, Coordinator of the Cardiac Rehabilitation Unit of Hospital Santo André
Principal Investigators
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Vitor Hugo Eira Pereira, MD, PhD
Role: STUDY_DIRECTOR
ICVS - Life and Health Sciences Research Institute, Minho University Medical School
Rui Manuel Fonseca Pinto, MD, PhD
Role: STUDY_DIRECTOR
ciTechCare - Center for Innovative Care and Health Technology, Polytechnic University of Leiria
João Carlos Araújo Morais, MD,PhD
Role: STUDY_DIRECTOR
ciTechCare - Center for Innovative Care and Health Technology
Locations
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ciTechCare - Center for Innovative Care and Health Technology
Leiria, Leiria District, Portugal
ICVS - Life and Health Sciences Research Institute, Minho University Medical School
Braga, Minho, Portugal
Countries
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References
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Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
Watson AM, Hood SG, May CN. Mechanisms of sympathetic activation in heart failure. Clin Exp Pharmacol Physiol. 2006 Dec;33(12):1269-74. doi: 10.1111/j.1440-1681.2006.04523.x.
Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016 Nov 7;37(42):3232-3245. doi: 10.1093/eurheartj/ehw334. Epub 2016 Aug 14. No abstract available.
Bento L, Fonseca-Pinto R, Povoa P. Autonomic nervous system monitoring in intensive care as a prognostic tool. Systematic review. Rev Bras Ter Intensiva. 2017 Oct-Dec;29(4):481-489. doi: 10.5935/0103-507X.20170072.
Sacramento JF, Ribeiro MJ, Rodrigues T, Olea E, Melo BF, Guarino MP, Fonseca-Pinto R, Ferreira CR, Coelho J, Obeso A, Seica R, Matafome P, Conde SV. Functional abolition of carotid body activity restores insulin action and glucose homeostasis in rats: key roles for visceral adipose tissue and the liver. Diabetologia. 2017 Jan;60(1):158-168. doi: 10.1007/s00125-016-4133-y. Epub 2016 Oct 16.
Sandesara PB, Lambert CT, Gordon NF, Fletcher GF, Franklin BA, Wenger NK, Sperling L. Cardiac rehabilitation and risk reduction: time to "rebrand and reinvigorate". J Am Coll Cardiol. 2015 Feb 3;65(4):389-395. doi: 10.1016/j.jacc.2014.10.059.
Adler AJ, Martin N, Mariani J, Tajer CD, Owolabi OO, Free C, Serrano NC, Casas JP, Perel P. Mobile phone text messaging to improve medication adherence in secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Apr 29;4(4):CD011851. doi: 10.1002/14651858.CD011851.pub2.
Besnier F, Labrunee M, Pathak A, Pavy-Le Traon A, Gales C, Senard JM, Guiraud T. Exercise training-induced modification in autonomic nervous system: An update for cardiac patients. Ann Phys Rehabil Med. 2017 Jan;60(1):27-35. doi: 10.1016/j.rehab.2016.07.002. Epub 2016 Aug 16.
Long L, Anderson L, He J, Gandhi M, Dewhirst A, Bridges C, Taylor R. Exercise-based cardiac rehabilitation for stable angina: systematic review and meta-analysis. Open Heart. 2019 Jun 5;6(1):e000989. doi: 10.1136/openhrt-2018-000989. eCollection 2019.
Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.
Andrade N, Alves E, Costa AR, Moura-Ferreira P, Azevedo A, Lunet N. Knowledge about cardiovascular disease in Portugal. Rev Port Cardiol (Engl Ed). 2018 Aug;37(8):669-677. doi: 10.1016/j.repc.2017.10.017. Epub 2018 Jul 25. English, Portuguese.
Abreu A, Mendes M, Dores H, Silveira C, Fontes P, Teixeira M, Santa Clara H, Morais J. Mandatory criteria for cardiac rehabilitation programs: 2018 guidelines from the Portuguese Society of Cardiology. Rev Port Cardiol (Engl Ed). 2018 May;37(5):363-373. doi: 10.1016/j.repc.2018.02.006. Epub 2018 Apr 30. English, Portuguese.
Atlas Writing Group; ESC Atlas of Cardiology is a compendium of cardiovascular statistics compiled by the European Heart Agency, a department of the European Society of Cardiology.; Developed in collaboration with the national societies of the European Society of Cardiology member countries; Timmis A, Townsend N, Gale CP, Torbica A, Lettino M, Petersen SE, Mossialos EA, Maggioni AP, Kazakiewicz D, May HT, De Smedt D, Flather M, Zuhlke L, Beltrame JF, Huculeci R, Tavazzi L, Hindricks G, Bax J, Casadei B, Achenbach S, Wright L, Vardas P. European Society of Cardiology: Cardiovascular Disease Statistics 2019 (Executive Summary). Eur Heart J Qual Care Clin Outcomes. 2020 Jan 1;6(1):7-9. doi: 10.1093/ehjqcco/qcz065. No abstract available.
Other Identifiers
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FCT 2024.04320.BD
Identifier Type: -
Identifier Source: org_study_id