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临床试验/NCT02448147
NCT02448147已完成不适用

Interval Training Versus Continuous Training on Peripheral Perfusion and Sympathetic Activity in Patients With Heart Failure

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Muscular sympathetic nervous activity

研究概览

简要总结

BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle disability and exercise intolerance. The interval exercise training has been proposed as one efficient method to heart failure patients. It seems that the main mechanism involved in the benefit of the interval exercise training is "shear stress". AIM: To study the interval exercise training versus the continuous exercise training in the sympathetic activity and in the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation, quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and female) with age between 30 and 60 years, left ventricular ejection fraction less than 40% and functional class I, II and III. These patients will be randomized into three groups: Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer, cardiopulmonary exercise test and quality of life before and after end of the period of 03 (three) months.

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
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •stable chronic heart failure without changing in treatment for at least 6 weeks
  • •ejection fraction less then 40%, as measured by transthoracic echocardiography
  • •optimal clinical treatment for chronic heart failure according to current guidelines.

排除标准

  • •asthma or chronic obstructive pulmonary disease using inhaled corticosteroids
  • •functional class IV (New York Heart Association - NYHA)
  • •atrial fibrillation
  • •complex ventricular arrhythmia
  • •pacemaker or implantable cardioversor/defibrillators
  • •chronic renal insufficiency, defined as serum creatinine above 2,5 mg/dL
  • •intermittent claudication
  • •morbid obesity
  • •cirrhosis
  • •alcoholism
  • •using illicit drugs
  • •performing regular physical activity
  • •participating in another study
  • •invasive procedure planned
  • •persistent nonadherence to therapeutic regimen
  • •peak respiratory exchange ratio (RER) lower than 1.00

研究组 & 干预措施

Interval training

Active Comparator

干预措施: Interval training (Behavioral)

Continuous training

Active Comparator

干预措施: Continuous training (Behavioral)

Control

No Intervention

结局指标

主要结局

Muscular sympathetic nervous activity

时间窗: 12 weeks

Muscular sympathetic nervous activity was measured by in peroneal nerve microneurography.

Peripheral muscular perfusion

时间窗: 12 weeks

Peripheral muscular perfusion was measured by near-infrared spectroscopy (NIRS) above vastus lateral muscle during exercise.

Biomarkers

时间窗: 12 weeks

Serum levels of biomarkers of inflammation (interleukin-6, tumor necrosis factor alpha and adiponectin) and fibrosis (galectin-3).

次要结局

  • Daily life physical activity(12 weeks)
  • MicroRNA(12 weeks)

研究者

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

Guilherme Veiga Guimarães,

Principal Investigator

University of Sao Paulo

研究点 (1)

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