<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274388</url>
  </required_header>
  <id_info>
    <org_study_id>EMS Nutr chronLiver</org_study_id>
    <nct_id>NCT03274388</nct_id>
  </id_info>
  <brief_title>Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease</brief_title>
  <official_title>Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the influence of an innovative combined therapy&#xD;
      involving optimized protein-rich nutritional therapy and highly effective muscle training by&#xD;
      personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass,&#xD;
      strength and functionality, physical capacity, fatigue and quality of life of patients with&#xD;
      chronic liver disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the course of chronic liver disease a systemic inflammatory reaction promotes mediators&#xD;
      leading to a loss of appetite, as well as to metabolic and hormonal changes. Consequences&#xD;
      hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of&#xD;
      muscles, with or without fat loss leading to cachexia. Especially muscle loss has a relevant&#xD;
      influence on morbidity and mortality of chronic liver patients. The loss of muscle is&#xD;
      probably due to a deteriorated protein synthesis with concurrent anabolic resistance. These&#xD;
      pathologic processes increase the protein requirements of chronic liver patients&#xD;
      dramatically.&#xD;
&#xD;
      The purpose of this study is to establish an innovative combined therapy involving optimized&#xD;
      nutritional therapy and highly effective muscle training by personalized whole-body&#xD;
      electromyostimulation (WB-EMS) exercise to improve the quality of life (QLQ) of patients with&#xD;
      serious chronic disease. An improvement of QLQ results from an increase in muscle mass and&#xD;
      strength, thereby increasing physical activity, physical capability as well as tolerance to&#xD;
      and applicability of therapy. In the course of a 3-months intervention study the efficacy of&#xD;
      a combined German-guidelines-recommended protein-rich nutritional therapy with an innovative&#xD;
      exercise therapy will be documented for patients with chronic liver disease. An effective&#xD;
      stopping of the progress of muscle wasting or even increase of muscle mass, strength and&#xD;
      function in the patients of the trial would benefit each patient and his family individually,&#xD;
      since it could mean a considerable improvement in his QLQ and tolerability of therapeutical&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>parallel group, controlled pilot study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking is not possible, since the &quot;intervention&quot; group receives exercise intervention in addition to protein-rich nutritional therapy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle mass of chronic liver patients</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength of chronic liver patients.</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life score as assessed by EORTC-QLQ-C30</measure>
    <time_frame>3 months</time_frame>
    <description>Increase or stabilization of quality of life score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score as assessed by visual analogue score</measure>
    <time_frame>3 months</time_frame>
    <description>Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue score as assessed by FACIT-Fatigue-Score analysis</measure>
    <time_frame>3 months</time_frame>
    <description>Increase or stabilization of fatigue score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)</measure>
    <time_frame>3 months</time_frame>
    <description>Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention of protein-rich nutritional therapy and counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>nutritional therapy</intervention_name>
    <description>protein-rich nutritional therapy and counseling, during study period of 12 weeks</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>WB-EMS combined with nutritional therapy</intervention_name>
    <description>protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients with chronic liver disease in curative or palliative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy persons or patients under age&#xD;
&#xD;
          -  Pregnancy, Lactation,&#xD;
&#xD;
          -  Psychological disorders, epilepsy, sever neurological disorders&#xD;
&#xD;
          -  Participation in other exercise- or nutrition studies within the last 6 months&#xD;
&#xD;
          -  acute cardiovascular disease&#xD;
&#xD;
          -  Rheuma&#xD;
&#xD;
          -  Intake of anabolic drugs,&#xD;
&#xD;
          -  Skin injuries in the area of electrode placements&#xD;
&#xD;
          -  Electronic implants (defibrillator, pacemaker)&#xD;
&#xD;
          -  Persons in mental hospitals by order of authorities or jurisdiction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Erlangen Nuremberg Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yurdaguel Zopf, Prof.</last_name>
    <phone>+49 9131 85-</phone>
    <phone_ext>35000</phone_ext>
    <email>yurdaguel.zopf@uk-erlangen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steffen Zopf, PD. Dr. med.</last_name>
    <phone>+49 9131 85-</phone>
    <phone_ext>35250</phone_ext>
    <email>steffen.zopf@uk-erlangen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg</name>
      <address>
        <city>Erlangen</city>
        <zip>91052</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yurdaguel Zopf, Prof</last_name>
      <phone>49 9131 8545218</phone>
      <email>yurdaguel.zopf@uk-erlangen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>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</citation>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>June 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274388
org study id: EMS Nutr chronLiver
nct id: NCT03274388
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: parallel group, controlled pilot study
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Masking is not possible, since the "intervention" group receives exercise intervention in addition to protein-rich nutritional therapy.
measure: Muscle mass of chronic liver patients
time frame: 3 months
description: 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.
measure: Muscle strength of chronic liver patients.
time frame: 3 months
description: 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.
measure: Quality of life score as assessed by EORTC-QLQ-C30
time frame: 3 months
description: Increase or stabilization of quality of life score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
measure: Pain score as assessed by visual analogue score
time frame: 3 months
description: Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
measure: Fatigue score as assessed by FACIT-Fatigue-Score analysis
time frame: 3 months
description: Increase or stabilization of fatigue score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
measure: Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)
time frame: 3 months
description: Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
arm group label: Control
arm group type: Experimental
description: Intervention of protein-rich nutritional therapy and counseling
arm group label: Intervention
arm group type: Experimental
description: Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training
intervention type: Procedure
intervention name: nutritional therapy
description: protein-rich nutritional therapy and counseling, during study period of 12 weeks
arm group label: Control
arm group label: Intervention
intervention type: Procedure
intervention name: WB-EMS combined with nutritional therapy
description: protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yurdaguel Zopf, Prof.
role: Principal Investigator
affiliation: University Erlangen Nuremberg Medical School
last name: Yurdaguel Zopf, Prof.
phone: +49 9131 85-
phone ext: 35000
email: yurdaguel.zopf@uk-erlangen.de
last name: Steffen Zopf, PD. Dr. med.
phone: +49 9131 85-
phone ext: 35250
email: steffen.zopf@uk-erlangen.de
facility: 
status: Recruiting
contact: 
country: Germany
citation: 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 type: Sponsor
mesh term: Liver Diseases