Not Yet RecruitingNot Applicable

TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

Brazil219 participantsStarted 2026-08-03

Plain-language summary

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 Saúde - SUS), will be enrolled.All participants will undergo standardized clinical and functional assessments at baseline, post-intervention, and short-term follow-up. Clinical screening and exercise stress testing will be performed at the Santa Catarina Institute of Cardiology (Instituto de Cardiologia de Santa Catarina - ICSC), whereas physical assessments and interventions will be conducted at the Center for Cardio-Oncology and Exercise Medicine (Núcleo de Cardio-Oncologia e Medicina do Exercício - NCME), State University of Santa Catarina (UDESC). The intervention will last 12 weeks, followed by an additional 12-week short-term follow-up period. Participants allocated to the HCTR group will receive a hybrid intervention consisting of face-to-face sessions, synchronous sessions supervised through videoconferencing, and remotely monitored asynchronous activities. Participants in the TCR group will participate exclusively in supervised face-to-face sessions, whereas participants in the UC group will receive usual clinical care, including conventional clinical guidance and an educational booklet. Study Significance: This clinical trial aims to generate evidence regarding adherence, effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation. Furthermore, it seeks to provide evidence to support the development and implementation of a hybrid cardiac telerehabilitation model adapted to the Brazilian context and the Brazilian Unified Health System (SUS), contributing to expanding access to cardiac rehabilitation through accessible digital technologies.

Who can participate

Age range

35 Years – 80 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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing different models of cardiovascular rehabilitation — can you explain what those models might look like in practice, and whether a telerehab approach would realistically fit into my daily life given my current condition?
2Since this trial is listed as 'not yet recruiting,' how long do you think it might be before it actually opens, and is there a standard cardiac rehab program I should be starting now in the meantime?
3The main thing this trial is measuring is whether people actually stick with the exercise program — what does that tell us about what's already known versus unknown about how well telerehab works for someone with my diagnosis?
4Given that this study covers a pretty wide range of conditions — from heart failure to acute coronary syndrome to coronary artery disease — does my specific situation put me in a category where one rehab model might be more appropriate than another?
5Are there any physical or logistical requirements for a telerehab-style program, like specific technology at home or a certain level of baseline fitness, that could affect whether this kind of trial would even be a realistic option for me to discuss further?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

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

Adherence to the Exercise Program

Timeframe: During the 12-week intervention period

Trial details

NCT IDNCT07734831

SponsorUniversity of the State of Santa Catarina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Ariella S Mangia, MSc, PhD(c)

55- 48- 3664-8643 ariella.mangia@edu.udesc.br

View on ClinicalTrials.gov More Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) trials