TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Adherence to the Exercise Program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adherence to the Exercise Program
时间窗: 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.
次要结局
- 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))
- Handgrip Strength(Baseline, 12 weeks (T1), and 24 weeks (T2))
- Health-Related Quality of Life(Baseline, 12 weeks (T1), and 24 weeks (T2))
研究者
Ariella Sebastião Mangia
Principal Investigator, PhD Candidate, Graduate Program in Human Movement Sciences, Santa Catarina State University
University of the State of Santa Catarina