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

October 15, 2018 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Recruiting
        • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMS Nutr chronLiver

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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