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临床试验/NCT01960127
NCT01960127已完成不适用

Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

University of Alberta2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Change in peak exercise pulmonary oxygen uptake (peak V02)

研究概览

简要总结

Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

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

入选标准

  • Age >18 and ≤ 70 years
  • Cirrhosis
  • Child Pugh class B or C
  • If required, primary or secondary variceal prophylaxis in place

排除标准

  • Post-liver transplantation
  • Hepatocelluar carcinoma beyond transplant criteria
  • Active non-hepatocelluar 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

结局指标

主要结局

Change in peak exercise pulmonary oxygen uptake (peak V02)

时间窗: Baseline (day1) 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 (day1) and Study End (8 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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