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临床试验/NCT04632914
NCT04632914Unknown不适用

Effect of Trunk Stabilizing Exercises on Sternal Instability and Separation in Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
sternal separation

研究概览

简要总结

PURPOSE:

The aim of this study is to investigate the effect of trunk stabilizing exercises 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 Trunk stabilizing exercises train and activate the abdominal and anterior thoracic cage muscles to assist in stabilizing the bisected sternum, thereby decreasing the undue motion in both sagittal and transverse planes during trunk movement. Patients' complaints of pain and discomfort associated with sternal instability post-cardiac surgery may be managed by diminishing the degree of this undue motion between the edges of the divided sternum, and thus provides a conservative treatment for sternal instability forty female patients will be divided into two groups. group A received trunk stabilizing exercise and group B will receive routine cardiac rehabilitation; three times/week for four weeks. the outcome variables were sternal instability and sternal separation and measured before and after completion of treatment

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

盲法说明

no masking

入排标准

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

入选标准

  • age between 40 and 50 years, female gender
  • 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
  • other medical conditions such as diabetes, uncontrolled hypertension and obesity
  • Past medical history that include conditions that may have influenced the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse

结局指标

主要结局

sternal separation

时间窗: it will be measured after four weeks

ultrasound unit will be used to measure the transverse distance between the two edges of stenum

次要结局

  • sternal instability(it will be measured after 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

principle investigator

Cairo University

研究点 (2)

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