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临床试验/NCT02265107
NCT02265107已完成不适用

Effects of Exercise Training on Vascular Endothelial Function of Patients Submitted to Coronary Artery Bypass Graft

Universidade Federal do Rio Grande (FURG)2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Vascular endothelial function

研究概览

简要总结

Objective: To observe the effects of exercise training on vascular endothelial function in patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months of Cardiac rehabilitation programs (CRP).

Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year to participate in a CRP with duration of six months with three weekly sessions of 1 and half hour of the duration. All patients underwent biochemical blood tests, muscle strength testing of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test (6MWT), and evaluation of endothelial function (using flow-mediated vasodilation).

详细描述

Introduction The cardiac rehabilitation optimizes a cardiac patient's physical, psychological, and social functioning, in addition to stabilizing, slowing, or even reversing the progression of the underlying atherosclerotic processes, thereby reducing morbidity and mortality. Patients who recently had had a myocardial infarction; or had undergone coronary artery bypass graft; or who had undergone percutaneous coronary interventions; or who are heart transplantation candidates or recipients; or have stable chronic heart failure, peripheral arterial disease with claudication, or other forms of CVD are candidates eligible for cardiac rehabilitation services ( , ).

Recently, studies randomized clinical trials have reported the efficacy of the exercise training (ET) independently of format of exercise: aerobic, resistance, or combined exercise training in patients with coronary artery disease ( , ) and, others studies investigated the effects of ET on vascular endothelial function in patients with stable coronary artery disease ( ), ischemic heart disease ( ), recent myocardial infarction (4), and chronic heart failure (3, , ). ET is associated with an improvement in endothelial function, oxidative stress, and inflammation. Furthermore, the ET promotes beneficial effects on cardiovascular outcomes and decreases hospitalizations.

Arterial endothelium function evaluated by flow-mediated vasodilation (FMD) is a predictor of long-term adverse cardiovascular outcomes in healthy subjects ( ). Vascular endothelial dysfunction is an independent risk factor for cardiovascular events and provides important prognostic data in addition to the more traditional risk factors ( ). Endothelial dysfunction plays an important role in patients with coronary atherosclerosis (both acute and chronic myocardial ischemia) and heart failure (3,5, ). Therefore, we aim to investigate the effect of combined exercise training on vascular endothelial function in sedentary patients submitted to coronary artery bypass graft (CABG) in late phase.

Methods The protocol was approved by the local ethics committee of Associação de Caridade Santa Casa do Rio Grande Hospital, Rio Grande/RS - Brazil, under the protocol number 003/2013. This study was non-randomized clinical trial. The written informed consent was obtained from all patients before of the onset of ET. The investigators invited all consecutive patients submitted to CABG alone at Cardiologic Hospital Doctor Pedro Bertoni of the Associação de Caridade Santa Casa do Rio Grande in the period of October, 2011 until October, 2012, who resided in the city of the Rio Grande (RS/Brazil), to participate of the ET. The investigators excluded the patients that performed others cardiologic procedures with the CABG. All patients were evaluated by cardiologist, and were ranked in Functional Classification of New York Heart Association (NYHA) such class I and II. Initially, twenty-four patients accepted and start to participate of ET, but only nine patients completed the program until the end.

The program of exercise training (ET) was employed for 6 consecutive months with 3 sessions per week. The training of physical activity consisted of a combination of aerobic and resistance exercises for upper and lower limbs. Each session included: (1) 5-minute warm-up, (2) 30 minutes of aerobic exercise (performed in treadmills and stationary bikes); (3) 20 minutes of resistance exercises with dumbbells for upper limbs and ankle support for lower limbs (exercises preformed in diagonals) that consisted of 6 sets of 10 resistance exercises repeated for upper limbs, and the same number of sets for lower limbs; and (4) 5-minute cool-down, totaling ninety minutes of session per day (90min/day) and, two hundred and seventy minutes per week (270min/week) ( ). Initialy, in aerobic exercises, the maximal HR to be achieved was established between 30-40% of HR at rest and, the aerobic exercise was limited by symptoms reported by patients. The initial weight of the dumbbells and ankle were established between 30-40% of one-repetition maximum test (1-RM test) and, gradually increased according to the symptoms reported by patients, without compensation of the trunk to perform the exercises, no history of muscle pain, and no muscle fatigue to complete all sessions. Heart rate (HR), respiratory rate (RR), saturation pulse of oxygen, and blood pressure were measured at the beginning, middle and end of each session. The intensity and the velocity of the exercise program were progressively increased.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • resided in the city of the Rio Grande (RS/Brazil);
  • age over 18 years-old;
  • evaluation and medical authorization.

排除标准

  • the patients that performed others cardiologic procedures with the Coronary Artery Bypass Graft

结局指标

主要结局

Vascular endothelial function

时间窗: after 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscila Aikawa

Priscila Aikawa PhD

Universidade Federal do Rio Grande (FURG)

研究点 (2)

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