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临床试验/NCT02343653
NCT02343653Unknown不适用

The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis

University of Aarhus1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
39
试验地点
1
主要终点
Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.

研究概览

简要总结

The purpose is to investigate the effect of strength training on muscle strength, muscle mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic and inflammatory changes during this intervention. In addition the investigator examine if the intervention is associated with fewer hospital readmission and an improved quality of life.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Cirrhosis, Child Pugh score A and B

排除标准

  • •Cirrhosis, Child-Pugh score C at inclusion
  • •Neurological and/or psychiatric disorder
  • •Pregnancy, breastfeeding
  • •Patients with malignancy
  • •Patients with hepatic encephalopathy at inclusion
  • •Patients with atypical diets, such as vegans

研究组 & 干预措施

Nutrition

Active Comparator

Participants receive a controlled diet consisting of 1.2-1.5 g of protein/kg/day for 12 weeks according to guidelines for enteral nutrition and patients with cirrhosis. The group receives dietary guidance and protein supplements.

干预措施: Nutrition (Behavioral)

Nutrition and strength training

Experimental

Participants in this group receive same controlled diet consisting of 1.2-1.5 g of protein/kg/day for 12 weeks as the "No intervention"-group. Participants will also receive supervised strength training 3 x 60 min./week for 12 weeks. The group receives dietary guidance and protein supplements, which on training days should be consumed within 30 minutes after exercise.

干预措施: Nutrition and strength training (Behavioral)

结局指标

主要结局

Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.

时间窗: 12-14 weeks

次要结局

  • Ammonia metabolism as measured by Oral Glutamine Challenge Test(12-14 weeks)
  • Nutritional status as measured by Triceps skinfold thickness (TSF), mid-upper-arm circumference (MUAC), mid-arm muscle area (MAMA) and hand dynamometer(12-14 weeks)
  • Readmissions as measured by a follow-up one year after the intervention.(1-1,5 year)
  • Quality of Life as measured by a standardized questionnaire (SF-36)(12-14 weeks)
  • Insulin sensitivity as measured by HOMA-IR(12-14 weeks)
  • Muscle mass as measured by MRi scan and bioimpedance scan.(12-14weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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