TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

Not yet recruitingNot applicableNCT07734831

View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Introduction: Cardiovascular diseases remain the leading cause of mortality worldwide. Despite the proven effectiveness of cardiac rehabilitation (CR) programs, adherence remains unsatisfactory, especially in public healthcare systems such as the Brazilian Unified Health System (Sistema Único de Saúde - SUS), due to logistical, geographical, and socioeconomic barriers. In this context, cardiac telerehabilitation (CTR) has emerged as a promising alternative, with effectiveness comparable to traditional center-based cardiac rehabilitation. However, evidence regarding hybrid cardiac telerehabilitation models applicable to the Brazilian context, using simple and low-cost technologies, remains scarce. Objectives: To investigate adherence and its effects on the effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation, with emphasis on the development and implementation of a hybrid cardiac telerehabilitation (HCTR) model adapted to the Brazilian context. The primary outcome will be adherence to the exercise program, defined as participation in at least 75% of the proposed sessions during the 12-week intervention. Secondary outcomes will include estimated cardiorespiratory fitness, functional capacity, functional mobility, handgrip strength, and health-related quality of life. Adverse events, digital health literacy, exercise maintenance, hospitalizations, and benefits and barriers to exercise will be evaluated as exploratory variables. Methods: This is a pragmatic, single-center, three-arm parallel randomized clinical trial consisting of hybrid cardiac telerehabilitation (HCTR), traditional center-based cardiac rehabilitation (TCR), and a usual care (UC) group. A total of 219 participants with coronary artery disease, with or without acute coronary syndrome, and/or stable heart failure, who are eligible for Phase II cardiac rehabilitation and receiving care through the Brazilian Unified Health System (Sistema Único de Sa…

Study details

Official title: TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation
Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Chronic Heart Failure
Acute Coronary Syndromes (ACS)
Interventions: Behavioral: Hybrid Cardiac Telerehabilitation
Behavioral: Traditional Center-Based Cardiac Rehabilitation (TCR)
Behavioral: Usual Care Group
Sponsor: University of the State of Santa Catarina
Collaborators: Instituto de Cardiologia de Santa Catarina
Start date: 2026-08-03
Primary completion: 2027-08
Sex: All
Age range: from 35 Years to 80 Years
Results posted: No results posted in this snapshot
Countries: Brazil
Total sites listed: 1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion Criteria: * Diagnosis of coronary artery disease (CAD), including patients with or without acute coronary syndrome (ACS), with or without ST-segment elevation, who were hospitalized for clinical management, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG). * Patients with heart failure and left ventricular ejection fraction (LVEF) \>20%. New York Heart Association (NYHA) functional class I-III. * Clinically stable patients without limiting angina. * Patients who meet the study eligibility criteria and provide informed consent to participate. Exclusion Criteria: * Decompensated severe heart failure. * Unstable angina. * Atrial fibrillation with rapid ventricular response. * Myocarditis, recent embolism, or thrombophlebitis. * Disabling musculoskeletal disorders that preclude participation in the exercise program. * History of cardiac arrest with disabling neurological sequelae. * Any decompensated medical condition that precludes participation in the study. * More than 2 months since hospital discharge before screening. * No access to the internet via smartphone or computer. * Unable to access or use the online intervention platform. * Absence of a caregiver or companion available at home during participation in the study.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07734831