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.
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.
Decompensated severe heart failure.
Unstable angina.
Atrial fibrillation with rapid ventricular response.
Myocarditis, recent embolism, or thrombophlebitis.
Parallel
Hybrid Cardiac Telerehabilitation
BehavioralA 12-week hybrid cardiac telerehabilitation program consisting of three supervised group exercise sessions per week delivered through a hybrid model that combines in-person activities, synchronous exercise sessions via videoconference, and remotely monitored asynchronous activities. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, light-to-moderate intensity aerobic exercise, and resistance exercises performed using elastic resistance bands. During the synchronous sessions, aerobic exercise will consist of rhythmic activities adapted for the home environment, including stationary marching, light displacement activities, alternating upper- and lower-limb movements, and low-impact functional exercises. During the asynchronous phase, participants will perform guided walking sessions and activities previously provided through instructional videos and educ
Traditional Center-Based Cardiac Rehabilitation (TCR)
BehavioralA 12-week supervised traditional center-based cardiac rehabilitation program consisting of three supervised group exercise sessions per week. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, aerobic exercise performed primarily on a treadmill or other equipment available at the cardiac rehabilitation center, and resistance exercises performed using elastic resistance bands. The intervention was designed to improve health-related physical fitness, functional capacity, quality of life, and adherence to regular physical exercise in patients eligible for Phase II cardiac rehabilitation.
Usual Care Group
BehavioralParticipants will remain under usual clinical care and will receive standard clinical guidance together with an educational booklet on the safe practice of physical exercise and cardiovascular health care.
Adherence to the Exercise Program
Adherence to the exercise program will be defined as attendance at ≥75% of the prescribed supervised exercise sessions during the 12-week intervention. Adherence will be assessed using attendance records for in-person and synchronous sessions and digital participation records for asynchronous activities, according to the allocated intervention group.
Peak Metabolic Equivalents (METs)
Peak exercise capacity will be assessed using the Exercise Stress Test and expressed as the maximum metabolic equivalents (METs) achieved during the test.
Estimated Peak Oxygen Uptake (VO₂)
Cardiorespiratory fitness will be assessed using the Exercise Stress Test and expressed as estimated peak oxygen uptake (VO₂), calculated using standardized prediction equations.
Exercise Test Duration
Exercise capacity will be assessed using the Exercise Stress Test and expressed as the total exercise duration completed during the test.
Functional Capacity
Functional capacity will be assessed using the 1-minute Sit-to-Stand Test, expressed as the total number of repetitions completed within one minute.
Adverse Events
Adverse events will be assessed through systematic recording of signs, symptoms, or clinical events occurring during supervised, synchronous, and remotely monitored exercise sessions throughout the study period.
Digital Health Literacy Assessed by the Brazilian eHealth Literacy Scale
Digital health literacy will be assessed using the Brazilian version of the eHealth Literacy Scale (eHEALS-Br), an 8-item instrument with responses rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 8 to 40, with higher scores indicating greater perceived digital health literacy. The total score will be analyzed as a potential explanatory variable associated with adherence and clinical outcomes.
Benefits and Barriers to Exercise
Benefits and barriers to exercise will be assessed using the Exercise Benefits/Barriers Scale (EBBS), a 43-item questionnaire with responses rated on a 4-point Likert scale. Total scores range from 43 to 172, with higher total scores indicating a more positive perception of exercise (greater perceived benefits relative to perceived barriers). The total EBBS score will be analyzed as a potential explanatory factor associated with adherence and exercise maintenance.
Exercise Maintenance
Exercise maintenance will be assessed using a standardized follow-up questionnaire to evaluate the continuation of regular physical exercise after completion of the supervised intervention.
Click on the lead sponsor to view all of their trials.
University of the State of Santa Catarina
Lead sponsor
Instituto de Cardiologia de Santa Catarina
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
