A Physical Activity Program in End-stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sarcopenia
研究概览
简要总结
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program. Secondary aims will focus on changes in anthropometrics, body composition, quality of life, and metabolic profile. This is a randomized clinical trial including 50 patients, with half allocated to the active group (physical training program) and half to standard of care.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to
- •Cirrhosis, any cause, defined as:
- •Biopsy-proven.
- •Two or more of the following: albumin <3.5 g/dL, International Normalized Ration (INR) >1.3, radiologic or endoscopic evidence of portal hypertension.
- •Creatinine <2.0 mg/dL.
- •Physiologic Model for End Stage Liver Disease (MELD) ≥
- •Decompensated cirrhosis with active or history of variceal bleeding, ascites, hepatic encephalopathy, or jaundice.
- •Potential transplant candidate as per UAMS criteria
排除标准
- •Large gastric or esophageal varices with contraindication to use beta-blockers.
- •Persistent hepatic encephalopathy grades 2-
- •Prior diagnosis of hepatocellular carcinoma, or hepatic hydrothorax (with prior repeated thoracocentesis).
- •Cirrhotic cardiomyopathy or congestive heart failure, pulmonary vascular complications, known active coronary artery disease, syncope, and cardiac dysrhythmias.
- •Physical impediment to perform a cardiorespiratory fitness test.
- •Use of implantable defibrillator or a pacemaker.
结局指标
主要结局
Sarcopenia
时间窗: Change from Baseline to 12 weeks after baseline
Total thigh muscle volume (cm\^3), as determined by CT-scan.
Physical Fitness - Distance Walked
时间窗: Change from Baseline to 12 weeks after baseline
Total distance walked during 6-minute walk test
Physical Fitness - VO2
时间窗: Change from Baseline to 12 weeks after baseline
Peak VO2 will be obtained from cardiorespiratory stress test
次要结局
未报告次要终点