Effects of a Physical Exercise Program on Cerebral and Hepatic Hemodynamics in Patients With Cirrhosis. (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Improvement in neurocognitive status-1
研究概览
简要总结
This study evaluates the effects of a structured exercise (The LFN-exercise protocol) program plus diet, on cerebral hemodynamics (cerebral blood flow) and hepatic hemodynamics (portal pressure), as well as on nutritional status (body composition and nutritional markers) in order to facilitate the prescription of exercise in patients with cirrhosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine <1.5 mg/dL; able to attend the appointed visits and willing to participate in the study.
排除标准
- •Presence of high-risk varices in upper endoscopy (red marks, large varices or gastric varices); concomitant cardiopulmonary diseases; decompensated Type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopaedic or osteomuscular limitations; any type of cancer, primary sclerosing cholangitis and Inflammatory bowel disease.
结局指标
主要结局
Improvement in neurocognitive status-1
时间窗: 12 weeks
improvement in neuropsychometric tests (PHES; psychometric Hepatic encephalopathy score)
Improvement in nutritional status
时间窗: 12 weeks
improvement in blood markers of nutritional status (measured in serum/RNA expression)
Improvement in Cerebral hemodynamics
时间窗: 12 weeks
improvement in transcranial Doppler ultrasound
Improvement in neurocognitive status-2
时间窗: 12 weeks
improvement in neuropsychometric tests (CFF; critical flicker frequency)
Changes in hepatic hemodynamics
时间窗: 12 weeks
Improvement in HVPG (HVPG; hepatic venous pressure gradient)
Improvement in body composition
时间窗: 12 weeks
improvement in body composition (BIA; Bioelectrical impedance analysis)
次要结局
- Physical activity(12 weeks)
- Physical fitness(12 weeks)
- Physical activity tolerance(12 weeks)
- Oxidative stress(12 weeks)