Cardiac and Endothelial Function Response to Early Exercise Training (CEFREET Study) After Coronary Artery Bypass Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Capacity - Six-Minute Walk Test (6MWT)
研究概览
简要总结
Background: Coronary artery bypass grafting (CABG) due to coronary artery disease (CAD) is one of the main surgical procedures performed in the area of cardiology. Individuals undergoing CABG present sarcopenia, decreased muscle strength of the lower limbs, decreased respiratory muscle strength and dyspnea due to immobility in the bed and the inherent conditions of the disease itself. Cardiorespiratory rehabilitation techniques are rarely used with measurement in hospitals and can greatly favor an early and effective reestablishment to this population in several parameters. Objective: To evaluate the effect of functional electrical stimulation (FES), ventilatory muscle training (TREMVEN), early aerobic training (AERO) and isometric handgrip training (ISO) on the functional capacity, endothelial function and cardiac parameters of individuals undergoing CABG. Methods: In a randomized clinical trial, volunteers will be allocated into four groups: EEF, TREMVEN, AERO or ISO in the preoperative period of CABG. After 48 hours (postoperative midway) of the surgery, the protocol will begin until after hospital discharge. The endpoints evaluated will be: functional capacity, respiratory muscle strength, systolic and diastolic function, arterial endothelial function, inflammatory profile and plasma levels of vascular endothelial growth factor (VEGF). Scientific contributions: Phase 1 cardiorespiratory rehabilitation with alternative interventions may provide an increase in functional capacity, strengthening of respiratory muscles, improvement in cardiac and endothelial functions, as well as increased systemic VEGF levels (myocardial revascularization) and improvement of the inflammatory profile, effectively forwarding the individuals to the rehabilitation phase 2.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be elective for the first CABG due to a previous ischemic event;
- •Do not present other associated heart diseases;
- •Absence of history of neuromuscular, autoimmune and infectious diseases;
- •Age between 50 to 75 years;
- •Signature of the Informed Consent Term.
- •No hyperreactivity during the pre-intervention evaluation tests;
- •No chronic renal failure; history of malignant disease with life expectancy <2 years;
- •No severe arrhythmias, angina pectoris, pulmonary embolism and thrombophlebitis;
- •Do not have orthopedic limitations or any physical or mental limitation that prevents the proposed exercises from being performed;
- •Present Left Ventricular Ejection Fraction (LVEF) > 40% in 48h after CABG, and
- •After the physical training period, individuals who have not completed a minimum of 80% of the protocol will be excluded from the sample due to refusal or withdrawal.
排除标准
- 未提供
研究组 & 干预措施
Ventilatory Muscle Training (TREMVEN)
The enrolled participants will perform inspiratory muscle training (IMT) for 20 minutes during the period of hospitalization, using the Power Breathe device (POWERbreathe International LTD). During training, subjects will be instructed to maintain diaphragmatic breathing at a rate at 15 to 20 breaths/min. The inspiratory load will be set at 30% of maximal static inspiratory pressure (PImax). It will be occur once per day until the hospital exit.
干预措施: Ventilatory Muscle Training (TREMVEN) (Other)
Aerobic Training (AERO)
It will consist of supervised walking, lasting 20 minutes a day, during the period of hospitalization of the participants. Heart rate (HR) will be constantly monitored through a cardiac monitor (Polar), with the objective of maintaining between 50 and 60% of the maximum HR predicted by age; Similar to 40 to 50% of VO2max. Blood pressure, oxygen saturation (SpO2) and level of dyspnea (Borg's effort perception scale) will also be monitored constantly. It will be occur once per day until the hospital exit.
干预措施: Aerobic Training (AERO) (Other)
Isometric Handgrip Training (ISO)
Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit.
干预措施: Isometric Handgrip Training (ISO) (Other)
结局指标
主要结局
Functional Capacity - Six-Minute Walk Test (6MWT)
时间窗: Pre and post (7 days) coronary artery bypass surgery
The 6MWT will be performed to assess functional capacity following the guidelines proposed by the American Thoracic Society.
次要结局
- Handgrip Strength(Pre and post (7 days) coronary artery bypass surgery)
- Cardiac Function - Echocardiography(Pre and post (7 days) coronary artery bypass surgery)
- Endothelial Function- Flow-Mediated Dilation (FMD)(Pre and post (7 days) coronary artery bypass surgery)
- Femoral Quadriceps Perimetry(Pre and post (7 days) coronary artery bypass surgery)
- Maximal Inspiratory Pressure(Pre and post (7 days) coronary artery bypass surgery)
- ELISA Immunoassay(Pre and post (7 days) coronary artery bypass surgery)