Effects of Cardiac Rehabilitation on Functional Capacity and Cardiovascular Risk Factors in Brazilian Patients Assisted by Public Health Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test
研究概览
简要总结
The purpose of this trial are to pragmatically investigate whether participation in a comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in better functional capacity, cardiovascular risk factor control, health behavior, disease-related knowledge, depressive symptoms and lower mortality when compared exercise only CR or wait list control.
详细描述
The design is a single-blinded, single-site pragmatic superiority RCT with 3 parallel arms: comprehensive CR (education and exercise) versus exercise-based CR (no education, as delivered in Brazil) versus wait list control (i.e., no CR). Patient assessments will be undertaken pre-randomization and again at 6 and 12 months later (in accordance with the end of CR). Mortality will be ascertained at 6 months and 1 year post-recruitment.
The main program is 6 months in duration, with 36 1-hour exercise sessions offered at the following frequencies:
- participants come to CR for 12 sessions, 3x a week (total of 4 weeks of intervention).
- participants come to CR for 8 sessions, 2x a week (total of 4 weeks of intervention).
- participants come to CR for 12 sessions, 1x a week (total of 12 weeks of intervention).
Each participant will receive an individualized exercise prescription based on a grade exercise stress test. Participants will be exercising between 50 and 80% of heart rate reserve. In all stages patients will be requested to exercise in their community other days of the week, to accumulate 30 or more minutes of physical activity at a moderate to vigorous-intensity 5 or more days per week, as recommended in the guidelines.
In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration. More specifically, the education component consists of:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 18 years old
- •patients living in the Belo Horizonte area
排除标准
- •any comorbid physical or serious mental condition which would interfere with the ability to exercise according to CR clinical practice guidelines (i.e., heart failure with ejection fraction less than 45%, complex ventricular dysrhythmia, advanced dementia, leg amputation, advanced cancer, disabling stroke, Parkinson's or substance dependence), and
- •any visual or cognitive condition which would preclude the participant from completing the questionnaires.
结局指标
主要结局
Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test
时间窗: Functional capacity measured by walked distance in the ISWT at 6 months
The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity.
次要结局
- Risk Factors Measurement of Fasting Blood Glucose Values(Glycaemia measured at 6 months)
- Risk Factors Measurement of Total Cholesterol Values.(Cholesterol measured at 6 months.)
- Risk Factors Measurement of Systolic Blood Pressure(Systolic blood pressure measured at 6 months)
- Risk Factors Measurement of Waist Circumference.(Waist circumference measured at 6 months)
研究者
Raquel Rodrigues Britto
PhD
Federal University of Minas Gerais