Effects of Phototherapy Associated to Exercise-based Cardiac Rehabilitation Program in Chronic Heart Failure: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Six-minute walk test to measure functional capacity change
研究概览
简要总结
Heart failure affects not only the cardiovascular system with structural abnormalities of the heart, but also the musculoskeletal system, leading to exercise intolerance. Objective: To evaluate the effects of a short-term exercise protocol and phototherapy, on the functional capacity and inflammatory markers in patients with heart failure. In addition, the investigators will investigate pulmonary function, peripheral and respiratory muscle strength and quality of life. Methods: Heart failure patients (left ventricular ejection fraction < 40%) will be selected from the outpatient clinic of the myocardium of the Department of Cardiology of Unifesp and randomized among two groups: patients who will be submitted to placebo phototherapy and cycle ergometer exercise; and patients who will be submitted to active phototherapy and cycle ergometer exercise. All groups will receive treatment twice a week for four weeks. Patients will be instructed to conduct home-based walking program at least twice a week. Patients will be evaluated before and after protocols regarding the pulmonary function, peripheral and respiratory muscle strength, functionality, quality of life and evaluation of systemic inflammatory mediators.
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
- 30 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 II and III.
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
Exercise and placebo phototherapy
Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
干预措施: Exercise (Other)
Exercise and placebo phototherapy
Placebo phototherapy and Cycle ergometer exercise rehabilitation protocol
干预措施: Placebo Phototherapy (Other)
Exercise and active phototherapy
Active phototherapy and Cycle ergometer exercise rehabilitation protocol
干预措施: Exercise (Other)
Exercise and active phototherapy
Active phototherapy and Cycle ergometer exercise rehabilitation protocol
干预措施: Active Phototherapy (Other)
结局指标
主要结局
Six-minute walk test to measure functional capacity change
时间窗: Pre and post 4 weeks of rehabilitation programs
According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Inflammatory markers
时间窗: Pre and post 4 weeks of rehabilitation programs
Evaluate the change in levels of interleukin (IL): IL-1 and IL-10, and tumor necrosis factor-alpha (TNF-α)
次要结局
- Respiratory muscle strength(Pre and post 4 weeks of rehabilitation programs)
- Peripheral muscle strength(Pre and post 4 weeks of rehabilitation programs)
- Quality of life(Pre and post 4 weeks of rehabilitation programs)
研究者
Caroline Bublitz Barbosa
Principal Investigator
Federal University of São Paulo