Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
2016年5月3日 更新者：Solange Guizilini、Federal University of São Paulo
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
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.
研究概览
地位
未知
详细说明
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
研究类型
介入性
注册 (预期的)
45
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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SP
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Sao Paulo、SP、巴西、04023062
- 招聘中
- Federal University of São Paulo
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接触：
- Solange Guizilini, PhD
- 电话号码：+5511982887753
- 邮箱：s_guizilini@yahoo.com.br
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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.
|
|
实验性的：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).
|
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).
|
|
实验性的：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.
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Capacity
大体时间：Up to ten days after surgery, at hospital discharge.
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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).
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Up to ten days after surgery, at hospital discharge.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Inflammatory markers
大体时间：in-hospital postoperative period, up to ten days after surgery.
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Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.
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in-hospital postoperative period, up to ten days after surgery.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Solange Guizilini, PhD、Federal University of São Paulo
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年6月1日
初级完成 (预期的)
2016年5月1日
研究完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2016年4月13日
首先提交符合 QC 标准的
2016年5月3日
首次发布 (估计)
2016年5月5日
研究记录更新
最后更新发布 (估计)
2016年5月5日
上次提交的符合 QC 标准的更新
2016年5月3日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.