Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease
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
- 否
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
Intervention of protein-rich nutritional therapy and counseling
干预措施: nutritional therapy (Procedure)
Intervention
Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training
干预措施: nutritional therapy (Procedure)
Intervention
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)
