TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

NCT07734831 | Not Yet Recruiting DMC

• 2 other identifiers: TELEREHAB-BR-RCT90207725.0.0000.0118
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)); Chronic Heart Failure; Acute Coronary Syndromes (ACS)

Keywords

Coronary Artery Disease; Heart Failure; Cardiac Rehabilitation; Telerehabilitation; Exercise Therapy; Health Literacy; Exercise Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  During the 12-week intervention period

Secondary Outcomes (7)

• Peak Metabolic Equivalents (METs)

  Baseline, 12 weeks (T1), and 24 weeks (T2)

• Estimated Peak Oxygen Uptake (VO₂)

  Baseline, 12 weeks (T1), and 24 weeks (T2)

• Exercise Test Duration

  Baseline, 12 weeks (T1), and 24 weeks (T2)

• Functional Capacity

  Baseline, 12 weeks (T1), and 24 weeks (T2)

• Functional Mobility

  Baseline, 12 weeks (T1), and 24 weeks (T2)

Other Outcomes (5)

• Adverse Events

  During the 12-week intervention period

• Digital Health Literacy Assessed by the Brazilian eHealth Literacy Scale

  Baseline, 12 weeks (T1), and 24 weeks (T2).

• Benefits and Barriers to Exercise

  Baseline, 12 weeks, and 24 weeks

Study Arms (3)

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 Rehabilitation

ACTIVE 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 Group

ACTIVE 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

Interventions

Hybrid Cardiac Telerehabilitation BEHAVIORAL

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

Hybrid Cardiac Telerehabilitation (HCTR)

Traditional Center-Based Cardiac Rehabilitation (TCR) BEHAVIORAL

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.

Traditional Center-Based Cardiac Rehabilitation

Usual Care Group BEHAVIORAL

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.

Usual Care Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead
• Instituto de Cardiologia de Santa Catarina: collaborator

Study Sites (1)

Centro de Ciências da Saúde e do Esporte (CEFID/UDESC)

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (1)

• Herdy AH, Mangia AS, Benetti M. Cardiovascular Telerehabilitation: An Alternative for Greater Availability of Cardiovascular and Metabolic Rehabilitation in Brazil. Arq Bras Cardiol. 2025 Mar;122(3):e20240570. doi: 10.36660/abc.20240570. English, Portuguese.

  PMID: 40197876 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction; Acute Coronary Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Magnus Benetti, PhD

  University of the State of Santa Catarina

  STUDY CHAIR

• Ariella S Mangia, MSc, PhD(c)

  University of the State of Santa Catarina

  PRINCIPAL INVESTIGATOR

• Artur H Herdy, PhD

  Instituto de Cardiologia de Santa Catarina

  STUDY CHAIR

• Gilvan M Pinto

  Instituto de Cardiologia de Santa Catarina

  STUDY CHAIR

• Cícero A de Souza, PHD

  Instituto de Cardiologia de Santa Catarina

  STUDY CHAIR

• Silvana M. de S. Pereira

  Instituto de Cardiologia de Santa Catarina

  STUDY CHAIR

Central Study Contacts

Ariella S Mangia, MSc, PhD(c)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate, Graduate Program in Human Movement Sciences, Santa Catarina State University

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)