Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Diseases

Intervention / Treatment
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* Procedure: nutritional therapy
* Procedure: WB-EMS combined with nutritional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients with chronic liver disease in curative or palliative treatment Exclusion Criteria: 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 Rheuma 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel group, controlled pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Intervention of protein-rich nutritional therapy and counseling | Procedure: nutritional therapy<br>* protein-rich nutritional therapy and counseling, during study period of 12 weeks<br>|
| Experimental: Intervention<br>Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training | Procedure: nutritional therapy<br>* protein-rich nutritional therapy and counseling, during study period of 12 weeks<br>Procedure: WB-EMS combined with nutritional therapy<br>* protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass of chronic liver patients | 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. | 3 months | 
| Muscle strength of chronic liver patients. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score as assessed by EORTC-QLQ-C30 | Increase or stabilization of quality of life score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. | 3 months | 
| Pain score as assessed by visual analogue score | Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. | 3 months | 
| Fatigue score as assessed by FACIT-Fatigue-Score analysis | Increase or stabilization of fatigue score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. | 3 months | 
| Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC) | Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. | 3 months |