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

NCT ID: NCT03274388

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Intervention of protein-rich nutritional therapy and counseling

Group Type: EXPERIMENTAL

nutritional therapy

Intervention Type: PROCEDURE

protein-rich nutritional therapy and counseling, during study period of 12 weeks

Intervention

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

Group Type: EXPERIMENTAL

nutritional therapy

Intervention Type: PROCEDURE

protein-rich nutritional therapy and counseling, during study period of 12 weeks

WB-EMS combined with nutritional therapy

Intervention Type: PROCEDURE

protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks

Interventions

nutritional therapy

protein-rich nutritional therapy and counseling, during study period of 12 weeks

Intervention Type: PROCEDURE

WB-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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yurdaguel Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yurdaguel Zopf, Prof.

Role: CONTACT

yurdaguel.zopf@uk-erlangen.de

+49 9131 85- ext. 35000

Steffen Zopf, PD. Dr. med.

Role: CONTACT

steffen.zopf@uk-erlangen.de

+49 9131 85- ext. 35250

Facility Contacts

Yurdaguel Zopf, Prof

Role: primary

yurdaguel.zopf@uk-erlangen.de

49 9131 8545218

References

Plauth M, Schuetz, T, Pirlich, M, Canbay, A, DGEM Steering Committee. S3-Leitlinie der DGEM in zusammenarbeit mit der GESKES, der AKE und der DGVS_ Klinische Ernährung in der Gastroenterologie (Teil1) - Leber. Aktuelle Ernaehrungsmedizin 39: e1-e42, 2014

Reference Type: BACKGROUND

Other Identifiers

EMS Nutr chronLiver

Identifier Type: -

Identifier Source: org_study_id