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临床试验/NCT04047901
NCT04047901Unknown不适用

Effect of Physical Training in Patients With Heart Failure Caused by Chemotherapy for Cancer Treatment

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Measure muscular sympathetic nervous activity

研究概览

简要总结

New therapies for cancer increased patient survival, but led to the recognition of adverse effects associated with cancer treatment, such as the use of chemotherapy. Cardiotoxicity is the most significant adverse effect, which affect the functional capacity and quality of life and is associated with high morbidity and mortality, regardless of the oncological prognosis. One of the manifestations of cardiotoxicity is ventricular dysfunction that can lead to heart failure. Neuro humoral hyperactivation with increased sympathetic nerve activity is a typical manifestation of heart failure and is associated with worse prognosis. Studies have shown that physical training significantly reduces sympathetic nerve activity in addition to improving muscle blood flow, reversing effects on skeletal muscle and improving quality of life. The hypothesis is that physical training may reduce sympathetic nerve activity and vasoconstrictor status in patients with heart failure caused by anthracyclines, as well as improving baroreflex and chemoreflex sensibility, mechanoreflex and metaborreflex control and skeletal myopathy.

详细描述

The investigators included patients> 18 years, left ventricular ejection fraction <= 0.55, functional class (NYHA) I-III, under medical treatment for heart failure. Patients with coronary artery disease, moderate to severe valve disease, positive Chagas serology, inability to participate in an exercise program are excluded.

Primary outcome: Muscle sympathetic nerve activity Secondary outcome: arterial baroreflex sensitivity, peripheral chemorreflex sensitivity, mecanic and muscuclar metaborreflex control, ubiquitin proteasome system activity.

Patients were divided into 2 groups-trained (n = 10) and non-trained (n = 10). Patients in the trained group will complete 16 weeks of aerobic training. Evaluation of cardiac function, functional capacity, quality of life and biochemical evaluation (troponin, hs-CRP and BNP). For muscle evaluation will be performed biopsy of the vastus lateralis muscle

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

入选标准

  • age 18 years old
  • Funcional Class I-III (NYHA)
  • Ejection fraction < o,55
  • treated for heart failure

排除标准

  • Coronary artery disease
  • Moderate to major valve disease
  • Positive serology for Chagas
  • Inability to perform physical exercises

研究组 & 干预措施

control group

No Intervention

A group of patients who will not be trained will be evaluated at baseline (pre) and after 16 weeks.

They are oriented to maintain lifestyle changes

Training group

Experimental

Patients will complete 16 weeks of training including 40 minutes of aerobic training, 15 minutes of resistive exercise and 5 minutes of relaxation.

干预措施: exercise training (Other)

结局指标

主要结局

Measure muscular sympathetic nervous activity

时间窗: 16 weeks

The sympathetic nervous activity is assessed by the microneurography technique

次要结局

  • Evaluate quimiorreflex sensibility(16 weeks)
  • Evaluate Mecanorreflex control(16 weeks)
  • Evaluate baroreflex activity(16 weeks)
  • Evaluate metaborreflex control(16 weeks)
  • Evaluation of skeletal myopathy(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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