TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial | NCT07734831

NCT07734831

Overview

NCT ID: NCT07734831
Lead Sponsor: University of the State of Santa CatarinaOTHER
Official Title: TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 3, 2026Estimated
Primary Completion Date: Aug 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 219Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Ariella S Mangia, MSc, PhD(c)Contact
ariella.mangia@edu.udesc.br55- 48- 3664-8643 ext. 48- 988714049

Similar Studies

Participant Group/Arms

Hybrid Cardiac Telerehabilitation (HCTR)Experimental

Participants assigned to this arm will undergo a 12-week hybrid cardiac telerehabilitation program consisting of in-person sessions, synchronous activities supervised by videoconference, and asynchronous activities remotely monitored, according to the structured exercise protocol developed for this study.

Behavioral: Hybrid Cardiac Telerehabilitation

Traditional Center-Based Cardiac RehabilitationActive Comparator

Participants assigned to this arm will undergo a 12-week supervised traditional center-based cardiac rehabilitation program at the Center for Cardiology and Exercise Medicine (NCME/UDESC), according to institutional organization and service availability, following the structured exercise protocol developed for this study.

Behavioral: Traditional Center-Based Cardiac Rehabilitation (TCR)

Usual Care GroupActive Comparator

Participants assigned to this arm will remain under usual clinical care for 12 weeks, receiving standard clinical guidance and an educational booklet on the safe practice of physical exercise developed specifically for this study. The educational booklet is intended to standardize the guidance provided to participants, promote the safe practice of physical exercise, and ensure a minimum level of care throughout the study period. If clinically indicated, participants may be referred to the center-based cardiac rehabilitation program during or after the study period, subject to service availability and the participant's willingness to participate.

Behavioral: Usual Care Group