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

Primary Purpose

Liver Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
nutritional therapy
WB-EMS combined with nutritional therapy
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Intervention

Arm Description

Intervention of protein-rich nutritional therapy and counseling

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

Outcomes

Primary Outcome Measures

Muscle mass of chronic liver patients
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.
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
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
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
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)
Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.

Full Information

First Posted
June 1, 2017
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03274388
Brief Title
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease
Official Title
Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Intervention of protein-rich nutritional therapy and counseling
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training
Intervention Type
Procedure
Intervention Name(s)
nutritional therapy
Intervention Description
protein-rich nutritional therapy and counseling, during study period of 12 weeks
Intervention Type
Procedure
Intervention Name(s)
WB-EMS combined with nutritional therapy
Intervention 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
Primary Outcome Measure Information:
Title
Muscle mass of chronic liver patients
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.
Time Frame
3 months
Title
Muscle strength of chronic liver patients.
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life score as assessed by EORTC-QLQ-C30
Description
Increase or stabilization of quality of life score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
Time Frame
3 months
Title
Pain score as assessed by visual analogue score
Description
Increase or stabilization of pain score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
Time Frame
3 months
Title
Fatigue score as assessed by FACIT-Fatigue-Score analysis
Description
Increase or stabilization of fatigue score of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
Time Frame
3 months
Title
Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)
Description
Decrease of common toxicity criteria regarding gastrointestinal complaints of chronic liver patients due to combinatorial therapy of protein-rich nutrition and WB-EMS.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdaguel Zopf, Prof.
Phone
+49 9131 85-
Ext
35000
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Steffen Zopf, PD. Dr. med.
Phone
+49 9131 85-
Ext
35250
Email
steffen.zopf@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof
Phone
49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de

12. IPD Sharing Statement

Citations:
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
Results Reference
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Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease

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