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临床试验/NCT00517738
NCT00517738已完成2 期

Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran4 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
29
试验地点
4
主要终点
Lack of deterioration in portal hypertension

研究概览

简要总结

Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.

详细描述

Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy-proven or clinically evident cirrhosis
  • Able to perform exercise

排除标准

  • Overt hepatic encephalopathy grades 3 or 4
  • Cardiovascular complications (pulmonary hypertension, heart failure)
  • Diabetes mellitus and microangiopathic complications, or under treatment with insulin
  • Renal failure
  • Portal hypertension with high risk for variceal bleeding
  • Hepatocellular carcinoma

结局指标

主要结局

Lack of deterioration in portal hypertension

时间窗: 3 months

This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization

Improvement in QOL questionnaires

时间窗: 3 months

QOL will be measured by means of SF-36 and CLDQ

次要结局

  • No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices(3 months)
  • Improvement in physical capacity and exercise tolerance(3 months)
  • Improvement in cognitive status(3 months)
  • Improved ammonia metabolism and decrease in oxidative stress(3 months)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Duarte-Rojo

MD, PhD

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (4)

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