An interventional study of Hybrid Cardiac Telerehabilitation and Traditional Center-Based Cardiac Rehabilitation (TCR) in Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Chronic Heart Failure and Acute Coronary Syndromes (ACS), sponsored by University of the State of Santa Catarina. Not yet recruiting at 1 site in Brazil. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of the State of Santa Catarina · Not applicable, Interventional, and Treatment
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 219 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of the State of Santa Catarina is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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
A 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
A 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.
Participants 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.
Time frame: During the 12-week intervention period
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.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
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.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
Exercise Test Duration
Exercise capacity will be assessed using the Exercise Stress Test and expressed as the total exercise duration completed during the test.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
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.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
Functional Mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test, expressed as the time required to complete the test in seconds.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
Handgrip Strength
Muscle strength will be assessed by handgrip strength using a Jamar hydraulic dynamometer, expressed in kilograms-force (kgf).
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
Health-Related Quality of Life
Health-related quality of life will be assessed using the EuroQol Five-Dimension Five-Level questionnaire (EQ-5D-5L). The instrument includes a descriptive system comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels ranging from no problems to extreme problems/unable to perform the activity. Responses define a health profile and are not summed into a total score. The questionnaire also includes the EuroQol Visual Analogue Scale (EQ VAS), which ranges from 0 (worst health imaginable) to 100 (best health imaginable). Higher EQ VAS scores indicate better perceived health status.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2)
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.
Time frame: During the 12-week intervention 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.
Time frame: Baseline, 12 weeks (T1), and 24 weeks (T2).
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.
Time frame: Baseline, 12 weeks, and 24 weeks
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.
Time frame: 24 weeks (end of follow-up)
Hospitalizations
Hospitalizations occurring from study enrollment until the end of the follow-up period will be assessed using a structured questionnaire and participant self-report.
Time frame: 24 weeks (end of follow-up)
Plan to share: No
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University of the State of Santa Catarina