跳至主要内容
临床试验/NCT03274388
NCT03274388Unknown不适用

Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017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
发起方
入组人数
50
试验地点
2
主要终点
Muscle mass of chronic liver patients

研究概览

简要总结

The purpose of this study is to explore the influence of an innovative combined therapy involving optimized protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, strength and functionality, physical capacity, fatigue and quality of life of patients with chronic liver disease.

详细描述

In the course of chronic liver disease a systemic inflammatory reaction promotes mediators leading to a loss of appetite, as well as to metabolic and hormonal changes. Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of muscles, with or without fat loss leading to cachexia. Especially muscle loss has a relevant influence on morbidity and mortality of chronic liver patients. The loss of muscle is probably due to a deteriorated protein synthesis with concurrent anabolic resistance. These pathologic processes increase the protein requirements of chronic liver patients dramatically.

The purpose of this study is to establish an innovative combined therapy involving optimized nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve the quality of life (QLQ) of patients with serious chronic disease. An improvement of QLQ results from an increase in muscle mass and strength, thereby increasing physical activity, physical capability as well as tolerance to and applicability of therapy. In the course of a 3-months intervention study the efficacy of a combined German-guidelines-recommended protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with chronic liver disease. An effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his QLQ and tolerability of therapeutical treatment.

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

盲法说明

Masking is not possible, since the "intervention" group receives exercise intervention in addition to protein-rich nutritional therapy.

入排标准

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

入选标准

  • Patients with chronic liver disease in curative or palliative treatment

排除标准

  • Healthy persons or patients under age
  • Pregnancy, Lactation,
  • Psychological disorders, epilepsy, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • acute cardiovascular disease
  • Intake of anabolic drugs,
  • Skin injuries in the area of electrode placements
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

研究组 & 干预措施

Control

Experimental

Intervention of protein-rich nutritional therapy and counseling

干预措施: nutritional therapy (Procedure)

Intervention

Experimental

Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training

干预措施: nutritional therapy (Procedure)

Intervention

Experimental

Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training

干预措施: WB-EMS combined with nutritional therapy (Procedure)

结局指标

主要结局

Muscle mass of chronic liver patients

时间窗: 3 months

Increase or stabilization of muscle mass of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. Muscle mass will be measured by Bioelectrical Impedance Analysis.

Muscle strength of chronic liver patients.

时间窗: 3 months

Increase or stabilization of muscle strength of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. Muscle strength will be measured by hand grip strength measurements.

次要结局

  • Pain score as assessed by visual analogue score(3 months)
  • Fatigue score as assessed by FACIT-Fatigue-Score analysis(3 months)
  • Quality of life score as assessed by EORTC-QLQ-C30(3 months)
  • Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)(3 months)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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