NCT03274388

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

June 1, 2017

Last Update Submit

October 15, 2018

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 months

  • 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.

    3 months

Secondary Outcomes (4)

  • Quality of life score as assessed by EORTC-QLQ-C30

    3 months

  • Pain score as assessed by visual analogue score

    3 months

  • Fatigue score as assessed by FACIT-Fatigue-Score analysis

    3 months

  • Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)

    3 months

Study Arms (2)

Control

EXPERIMENTAL

Intervention of protein-rich nutritional therapy and counseling

Procedure: nutritional therapy

Intervention

EXPERIMENTAL

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

Procedure: nutritional therapyProcedure: WB-EMS combined with nutritional therapy

Interventions

nutritional therapyPROCEDURE

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

ControlIntervention
WB-EMS combined with nutritional therapyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic liver disease in curative or palliative treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91052, Germany

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yurdaguel Zopf, Prof.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurdaguel Zopf, Prof.

CONTACT

+49 9131 85-yurdaguel.zopf@uk-erlangen.de

Steffen Zopf, PD. Dr. med.

CONTACT

+49 9131 85-steffen.zopf@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible, since the "intervention" group receives exercise intervention in addition to protein-rich nutritional therapy.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: parallel group, controlled pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2017

First Posted

September 6, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

DE(1)