Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- SF-36
研究概览
简要总结
Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of patients with liver cirrhosis.
详细描述
70 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 5 patients refused to participate .65 patients divided randomly into 2 groups. All the procedures were explained to patients.2 patients refused to sign informed consent and excluded from the study. 31 patients in group1 and 32 patients in group2. 1patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.
Thirty patients in each group signed an informed consent and complete the treatment program.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for anti-HCV.
- •Not under antiviral therapy at entry.
- •Positive for chronic hepatitis or compensated cirrhosis.
- •Negative for hepatitis B surface (HBs) antigen.
- •Free of co-infection with HIV.
- •Not pregnant.
- •Systolic blood pressure of less than 180 mmHg or diastolic blood pressure of less than 110 mmHg.
- •(viii)No ischemic heart disease or severe arrhythmia
排除标准
- •Significant cardiac disease (ejection fraction <60% or history of coronary artery disease).
- •Chronic renal failure on dialysis.
- •Hemoglobin <11.0 g/L.
- •Human immunodeficiency virus infection.
- •Hepatocellular carcinoma.
- •Active non-hepatocellular carcinoma related malignancy.
- •Myopathy.
- •Any physical impairment or orthopedic abnormality preventing EX, or post-liver transplantation
结局指标
主要结局
SF-36
时间窗: 12 week
Score
Sitting standing test
时间窗: 12 week
number of cycle /30 seconds
Balance
时间窗: 12 weeks
Seconds
Time up and go test
时间窗: 12 weeks
number of cycle / minute
6 Minutes walk distance
时间窗: 12 weeks
distance walked in 6 minutes
2 Minutes steps test
时间窗: 12 weeks
number of steps in 2 minutes.
Chronic liver diseases questionnaire (CLDQ)
时间窗: 12 week
score
次要结局
未报告次要终点
研究者
Manal k. youssef
Assistant professor
Cairo University