Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Increase in muscle mass
研究概览
简要总结
The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.
详细描述
Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times per week during three months and relaxation after exercise. Control group: only relaxation 1 hour three times per week during three months.
Assessment: clinical and laboratory examinations performed at baseline and at the end of the study. The investigators will analyze the changes in muscle mass by anthropometric measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test), quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and inflammatory response. The investigators will analyze the survival and complications of cirrhosis during the study and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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, relaxation
Active comparator: Exercise + relaxation Patients will perform exercise + relaxation for 3 months
干预措施: Exercise + relaxation (Other)
Relaxation
Relaxation without exercise Patients will receive only relaxation for 3 months
干预措施: Relaxation (Other)
结局指标
主要结局
Increase in muscle mass
时间窗: Basal and three months
Change in Effort tolerance
时间窗: Basal and three months
次要结局
未报告次要终点
研究者
German Soriano
Dr. German Soriano Pastor Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau