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临床试验/NCT02567591
NCT02567591已完成不适用

Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation

University Hospital, Limoges4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

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
4
主要终点
VO2 max at 12 weeks

研究概览

简要总结

Physical exercise has been identified as a major beneficial factor in the management of patients suffering from many chronic diseases especially cancer and in the context of cardiac or pulmonary transplantation. It contributes to an improvement of the quality of life and decreases treatment side effects and mortality. Aerobic fitness is constantly altered in cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this setting, other etiological factors may be added like chronic obstructive bronchitis and alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps have been described. Muscle weakness in this condition may be comparable to that described in patients with chronic obstructive bronchitis and contributes to the decrease of aerobic fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition, anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number and the length of hospitalizations after liver transplantation (LT).

Therefore, physical activity is a valid and relevant way to improve quality of life, increase survival, and limit costs of hospitalizations. The aim of this study is to assess the effects of a personalized physical activity retraining program on aerobic capacity, strength and fatigue, in a population awaiting liver transplantation.

Purpose: The hypothesis is that an at home adapted retraining program conducted before LT, and including physical activity (aerobic and strength training), will improve aerobic fitness, peripheral strength, quality of life and decrease the hospitalization length in intensive care unit after LT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Males and females between 18 and 70 years of age,
  • Signed informed consent,
  • Medical indication to LT whatever the cause of the liver disease

排除标准

  • Inability to understand the instructions of the trial,
  • Patients who are subject to a court protection, wardship or guardianship order,
  • Uncontrolled cardiac disease and ventricular ejection fraction (vef) < 50 %,
  • Any other serious conditions which are not stabilized and in which physical exercise is contra-indicated,
  • Pregnancy or suckling,
  • Patients transplanted in extreme emergency.

研究组 & 干预措施

A: physical activity program

Experimental

at home physical activity program (during 12 weeks)

干预措施: Physical activity (Other)

B: conventional management

No Intervention

conventional management

结局指标

主要结局

VO2 max at 12 weeks

时间窗: at 12 weeks

To evaluate the impact of a personalized physical activity program after 12 weeks of exercise on the aerobic capacity measured by VO2 max, in patients awaiting liver transplantation.

次要结局

  • 6 minutes walk test at week 12(at 12 weeks)
  • After liver transplantation: aerobic capacity (VO2 max)(3 and 6 months after liver transplantation)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (4)

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