Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Six-minute walk test to measure functional capacity change
研究概览
简要总结
Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) < 40%
- •New York Heart Association (NYHA) classes III and IV.
排除标准
- •chronic lung disease confirmed by pulmonary function testing
- •unstable angina pectoris and acute coronary syndromes
- •neuromuscular and psychiatric conditions that interfere in exercise
研究组 & 干预措施
Conventional exercise protocol
Conventional global exercise
干预措施: Conventional exercise protocol (Other)
Cycle ergometer exercise protocol
Stationary cycle ergometer exercise
干预措施: Cycle ergometer exercise protocol (Other)
结局指标
主要结局
Six-minute walk test to measure functional capacity change
时间窗: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).
According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Respiratory muscle strength
时间窗: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation)
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
次要结局
- Invasive mechanical ventilation(First day after transplantation.)
- Duration of intensive care unit stay(In hospital discharge (after 4 weeks of transplantation).)
- Hospitalization stay(In hospital discharge (after 4 weeks of transplantation).)
研究者
Caroline Bublitz Barbosa
Principal Investigator
Federal University of São Paulo