Liver Diseases
Conditions
Brief summary
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
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.
Interventions
PROCEDUREnutritional therapy
protein-rich nutritional therapy and counseling, during study period of 12 weeks
PROCEDUREWB-EMS combined with nutritional therapy
protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Masking is not possible, since the intervention group receives exercise intervention in addition to protein-rich nutritional therapy.
Intervention model description
parallel group, controlled pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass of chronic liver patients | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score as assessed by FACIT-Fatigue-Score analysis | 3 months | Increase or stabilization of fatigue score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. |
| Quality of life score as assessed by EORTC-QLQ-C30 | 3 months | Increase or stabilization of quality of life score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. |
| Pain score as assessed by visual analogue score | 3 months | Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. |
| Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC) | 3 months | Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS. |
Countries
Germany
Contacts
Primary ContactYurdaguel Zopf, Prof.
Backup ContactSteffen Zopf, PD. Dr. med.
Outcome results
None listed