TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

Официальное название

TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation

Обзор

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.

Вмешательства

• Поведенческое Hybrid 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 ae
• Поведенческое Traditional 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 resi
• Поведенческое Usual 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.

Первичные конечные точки

• Adherence to the Exercise Program [Срок оценки: During the 12-week intervention period]

Вторичные конечные точки (7)

• Peak Metabolic Equivalents (METs) [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Estimated Peak Oxygen Uptake (VO₂) [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Exercise Test Duration [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Functional Capacity [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Functional Mobility [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Handgrip Strength [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]
• Health-Related Quality of Life [Срок оценки: Baseline, 12 weeks (T1), and 24 weeks (T2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT07734831 · TELEREHAB-BR-RCT · 90207725.0.0000.0118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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