Acute Coronary Syndromes (ACS), Chronic Heart Failure, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Conditions
Keywords
Coronary Artery Disease, Heart Failure, Cardiac Rehabilitation, Telerehabilitation, Exercise Therapy, Health Literacy, Exercise Adherence
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.
Interventions
BEHAVIORALHybrid Cardiac Telerehabilitation
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
BEHAVIORALTraditional Center-Based Cardiac Rehabilitation (TCR)
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.
BEHAVIORALUsual Care Group
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.
Sponsors
University of the State of Santa Catarina
Instituto de Cardiologia de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Exercise Program | During the 12-week intervention period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Metabolic Equivalents (METs) | Baseline, 12 weeks (T1), and 24 weeks (T2) | 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) | Baseline, 12 weeks (T1), and 24 weeks (T2) | 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 | Baseline, 12 weeks (T1), and 24 weeks (T2) | Exercise capacity will be assessed using the Exercise Stress Test and expressed as the total exercise duration completed during the test. |
| Functional Capacity | Baseline, 12 weeks (T1), and 24 weeks (T2) | Functional capacity will be assessed using the 1-minute Sit-to-Stand Test, expressed as the total number of repetitions completed within one minute. |
| Functional Mobility | Baseline, 12 weeks (T1), and 24 weeks (T2) | Functional mobility will be assessed using the Timed Up and Go (TUG) test, expressed as the time required to complete the test in seconds. |
| Handgrip Strength | Baseline, 12 weeks (T1), and 24 weeks (T2) | Muscle strength will be assessed by handgrip strength using a Jamar hydraulic dynamometer, expressed in kilograms-force (kgf). |
| Health-Related Quality of Life | Baseline, 12 weeks (T1), and 24 weeks (T2) | 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. |
Countries
Brazil
Contacts
CONTACTAriella S Mangia, MSc, PhD(c)
STUDY_CHAIRMagnus Benetti, PhD
University of the State of Santa Catarina
PRINCIPAL_INVESTIGATORAriella S Mangia, MSc, PhD(c)
University of the State of Santa Catarina
STUDY_CHAIRArtur H Herdy, PhD
Instituto de Cardiologia de Santa Catarina
STUDY_CHAIRGilvan M Pinto
Instituto de Cardiologia de Santa Catarina
STUDY_CHAIRCícero A de Souza, PHD
Instituto de Cardiologia de Santa Catarina
STUDY_CHAIRSilvana M. de S. Pereira
Instituto de Cardiologia de Santa Catarina
Outcome results
None listed