Impact and Safety of a Physical Training Program on Health-related Quality of Life in Patients With Cirrhosis and Portal Hypertension
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
- 否
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
Andres Duarte-Rojo
MD, PhD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
