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临床试验/NCT04949581
NCT04949581Unknown不适用

Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
sternal instability

研究概览

简要总结

The aim of this study is to investigate the effect of bioelectric therapy on sternal instability in patients with median sternotomy after heart valve surgery.

详细描述

Valvular heart disease constitutes a growing healthcare problem with a general prevalence of 2%-5% and a prevalence of 13% after the age of 75 years Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease. Nevertheless, following the surgery, up to 27% of patients may require readmission within 30 days after discharge. Following heart valve surgery, some patients report anxiety and worries related to readmission and reoperations, postoperative complications, and deconditioning which may prevent or delay return to work and limit activities of daily living.Over the past 30 years, bone-growth stimulators have become a critical component in fracture care. They can be classified into four categories: direct-current (DC) devices, inductive coupling, noninvasive capacitive coupling, and low-intensity ultrasound. Microcurrent electrical stimulation ( MES) is the therapeutic use of constant (DC) and pulsed (interrupted) currents, where the stimulus amplitude is in the micro amperage (millionth of an ampere) range. MES is defined as those of less than 1 mA or 1000 μ, (MES < 1 mA). This form of electrical stimulation tends to be applied at the suspensory or very low sensory level and they are not designed to stimulate muscle contraction. Generators that produce MES were originally called microcurrent electrical neuromuscular stimulators (MENS). However, the stimulation pathway is not the usual neural pathway, and they are not designed to stimulate muscle contraction. Consequently, this type of generator was subsequently referred to as a microcurrent electrical stimulator (MES). The use of MES may be an adjunctive modality in the treatment of fractures or injury sites, especially fractures prone to nonunion. Fracture healing may be accelerated by passing a monophasic current through the fracture site. Getting the current into the bony area without an invasive technique is difficult.forty subjects will be allocated to two groups; one group will receive micro-current therapy and routine cardiac rehabilitation program both for four weeks and the control group will receive the cardiac rehabilitation program only for four weeks.

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
Double (Participant, Outcomes Assessor)

盲法说明

random generator

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • there age between 40 and 50 years,
  • hemodynamic stability
  • BMI from 25 to 29.9 kg/m2,
  • they will have acute sternal instability.

排除标准

  • previous thoracic surgery
  • elective and urgent coronary artery bypass surgery
  • respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg
  • renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery
  • low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension, according to the American College of Cardiology Foundation and American Heart Association

结局指标

主要结局

sternal instability

时间窗: up to four weeks

sternal instability scale will be used for assessment. this scale has four points. zero mean more stability and three mean completly separated

次要结局

  • sternal separation(up to four weeks)

研究者

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

Al Shaymaa Shaaban Abd El Azeim

al shaymaa shaaban abd el azeim

Cairo University

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