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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Liver Diseases

Treatments: Procedure: nutritional therapy; Procedure: WB-EMS combined with nutritional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03274388

EMS Nutr chronLiver

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

Experimental group

Description:

Intervention of protein-rich nutritional therapy and counseling

Treatment:

Procedure: nutritional therapy

Intervention

Experimental group

Description:

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

Treatment:

Procedure: nutritional therapy

Procedure: WB-EMS combined with nutritional therapy