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临床试验/NCT03728075
NCT03728075已完成不适用

The Role of Neuromuscular Electrical Stimulation in Regulation of Serum IL-6 and IL-15 in Chronic Heart Failure Patients

Dr. Soetomo General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月21日最近更新:
适应症

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
2
主要终点
IL-6 and IL-15

研究概览

简要总结

The purpose of the study is investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol

详细描述

Majority of chronic heart failure patients became intolerance of physical training that could limit activity. Recent studies reported that Neuromuscular electrical stimulation (NMES) application could increase muscle mass, oxidative enzyme, endothelial function, VO2 peak and quality of life in chronic heart failure patient. It was hypothesized that Neuromuscular Electrical Stimulation (NMES) assisted muscle contraction in chronic heart failure patients will increase the activity of myokine (Interleukin-6 and Interleukin-15), that in turn will promote exercise tolerance in this patient. the aim of this study was to investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol. Thirty chronic heart failure patients in cardiology ward that fulfilled inclusion criteria were randomized in two groups; the control group (standard inpatient cardiac rehabilitation protocol) and the intervention group (standard inpatient cardiac rehabilitation protocol and NMES). The intervention was done every day for seven days. Measurement of serum IL-6 and IL-15 were done before and after study, and analyzed by sandwich immunoassay with monoclonal antibody.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • heart failure patients admitted to the hospital NYHA II-III
  • no weakness of lower limbs
  • stable hemodynamic, already received standard treatment based on patient condition
  • able to follow instruction
  • lived at Surabaya or Sidoarjo
  • assigned the informed consent

排除标准

  • knee osteoarthritis with knee pain that interfere the ambulation
  • phlebitis and active bleeding on lower limb
  • use vasoactive drug (such as Dobutamin etc)
  • already receive NMES before at femoris area in last 6 weeks before admission
  • fracture of lower limb that interfere the ambulation
  • sensory deficit at lower limb
  • acute infection

结局指标

主要结局

IL-6 and IL-15

时间窗: before and 7th day of treatment

pg/ml

次要结局

未报告次要终点

研究者

发起方
Dr. Soetomo General Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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