NCT02267421已完成不适用
An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in peak exercise pulmonary oxygen uptake (VO2peak).
研究概览
简要总结
Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.
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
- •Age >18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place
排除标准
- •Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (<80 g/L) Oxygen saturation at rest <95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C
结局指标
主要结局
Change in peak exercise pulmonary oxygen uptake (VO2peak).
时间窗: Baseline (day 1) and Study End (8 weeks)
次要结局
- Change in muscle mass as measured by thigh ultrasound(Baseline (day 1) and Study end (8 weeks))
- Change in quality of life - Chronic Liver Disease Questionnaire(Baseline (Day 1) and Study completion (8 weeks))
- Change in muscle oxygen extraction and consumption as measured by MRI(Baseline (day 1) and study completion (8 weeks))
研究者
研究点 (2)
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