Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Functional Capacity
研究概览
简要总结
This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction. Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.
详细描述
Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.
Walking
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 (Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease proven by coronary angiography;
- •Elective CABG;
- •No acute or chronic pulmonary disease;
- •Patients after surgery, keep in spontaneous ventilation on first postoperative day;
- •Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
- •Consent form signed for participation in the survey.
排除标准
- •Inability to perform spirometry;
- •Presence of acute lung disease or chronic;
- •Surgical indication of urgency;
- •Morbid obesity;
- •Hemodynamics instability at the time of spirometry or during six minutes walking test;
- •Intraoperative death or until the sixth postoperative day;
- •Patients remaining in mechanical prolonged ventilation for more than 12 hours;
- •Severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; Any change that may lead to failure of proposed protocols.
研究组 & 干预措施
Walking exercise
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking.
干预措施: Walking exercise (Other)
Stationary cycling exercise
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
干预措施: Stationary cycling exercise (Other)
Neuromuscular electrical stimulation
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.
干预措施: Neuromuscular electrical stimulation (Other)
结局指标
主要结局
Functional Capacity
时间窗: Up to ten days after surgery, at hospital discharge.
Participants will be submitted to six minute walk test on preoperative period and sixth postoperative day (or before hospital discharge) to evaluate functional capacity. The test will be performed with a mobile device to measure metabolic response to exercise (Oxycon™ Mobile).
次要结局
- Inflammatory markers(in-hospital postoperative period, up to ten days after surgery.)
研究者
Solange Guizilini
PhD
Federal University of São Paulo