Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- glutamine synthetase activity
研究概览
简要总结
This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •compensated liver cirrhosis.
排除标准
- •hepatocellular carcinoma,
- •active alcoholism (less than 1 year),
- •decompensated cirrhosis,
- •variceal bleeding less than 3 months,
- •contraindication for exercise.
研究组 & 干预措施
Exercise + Leucine
Patients will receive leucine 10 g/d po + exercise for 3 months
干预措施: Leucine supplements (Dietary Supplement)
Leucine without exercise
patients will receive leucine 10 g/d po
干预措施: Leucine supplements (Dietary Supplement)
结局指标
主要结局
glutamine synthetase activity
时间窗: three months
次要结局
- quality of life(three months)
研究者
German Soriano
Dr. German Soriano Pastor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau