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Trial record 18 of 7007 for:    "Liver Diseases"

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT03274388
First received: June 1, 2017
Last updated: September 4, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Liver Diseases Procedure: nutritional therapy Procedure: WB-EMS combined with nutritional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
parallel group, controlled pilot study
Masking: None (Open Label)
Masking Description:
Masking is not possible, since the "intervention" group receives exercise intervention in addition to protein-rich nutritional therapy.
Primary Purpose: Supportive Care
Official Title: Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Muscle mass of chronic liver patients [ Time Frame: 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. [ Time Frame: 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 Outcome Measures:
  • Quality of life score as assessed by EORTC-QLQ-C30 [ Time Frame: 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 [ Time Frame: 3 months ]
    Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.

  • Fatigue score as assessed by FACIT-Fatigue-Score analysis [ Time Frame: 3 months ]
    Increase or stabilization of fatigue 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) [ Time Frame: 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.


Estimated Enrollment: 50
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control
Intervention of protein-rich nutritional therapy and counseling
Procedure: nutritional therapy
protein-rich nutritional therapy and counseling, during study period of 12 weeks
Experimental: Intervention
Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training
Procedure: nutritional therapy
protein-rich nutritional therapy and counseling, during study period of 12 weeks
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03274388

Contacts
Contact: Yurdaguel Zopf, Prof. +49 9131 85- ext 35000 yurdaguel.zopf@uk-erlangen.de
Contact: Steffen Zopf, PD. Dr. med. +49 9131 85- ext 35250 steffen.zopf@uk-erlangen.de

Locations
Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Yurdaguel Zopf, Prof    49 9131 8545218    yurdaguel.zopf@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Yurdaguel Zopf, Prof. University Erlangen Nuremberg Medical School
  More Information

Publications:
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

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03274388     History of Changes
Other Study ID Numbers: EMS Nutr chronLiver
Study First Received: June 1, 2017
Last Updated: September 4, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 20, 2017