Liver DiseasesNCT03274388
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Chronic Liver Disease
A study testing nutritional therapy and WB-EMS combined with nutritional therapy in people with Liver Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- nutritional therapy and WB-EMS combined with nutritional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic liver disease in curative or palliative treatment
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, 91052
Yurdaguel Zopf, Prof, 49 9131 8545218, yurdaguel.zopf@uk-erlangen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Diseases
- Being tested
- nutritional therapy, WB-EMS combined with nutritional therapy
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional therapyProcedure or surgery
protein-rich nutritional therapy and counseling, during study period of 12 weeks
WB-EMS combined with nutritional therapyProcedure or surgery
protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Intervention of protein-rich nutritional therapy and counseling Receives: Procedure: nutritional therapy |
| Intervention | Experimental | Intervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training Receives: Procedure: nutritional therapy; Procedure: WB-EMS combined with nutritional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Jan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group, controlled pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yurdaguel Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274388
- Sponsor's protocol ID
- EMS Nutr chronLiver
- Status last verified
- Oct 2018
- First submitted
- 1 Jun 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Individualized Nutritional Therapy Combined With Whole Body Electromyostimulation on Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT03274388
- Acronym / sponsor ID
- EMS Nutr chronLiver
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel group, controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Procedure: nutritional therapyIntervention of protein-rich nutritional therapy and counseling |
| Intervention | Experimental | Procedure: nutritional therapy, Procedure: WB-EMS combined with nutritional therapyIntervention of protein-rich nutritional therapy and counseling combined with whole body electromyostimulation exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic liver disease in curative or palliative treatment
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional therapyprotein-rich nutritional therapy and counseling, during study period of 12 weeks | Procedure or surgery | Control, Intervention |
| WB-EMS combined with nutritional therapyprotein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks | Procedure or surgery | Intervention |
Primary outcome
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.
4 secondary outcomes
Quality of life score as assessed by EORTC-QLQ-C30
Time frame: 3 months
Pain score as assessed by visual analogue score
Time frame: 3 months
Fatigue score as assessed by FACIT-Fatigue-Score analysis
Time frame: 3 months
Degree of toxicity of chemotherapy regarding gastrointestinal complaints as assessed by Common Toxicity Criteria (CTC)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- BackgroundPlauth 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yurdaguel Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional therapy and WB-EMS combined with nutritional therapy in people with Liver Diseases, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yurdaguel Zopf, Prof. (+49 9131 85- ext. 35000, yurdaguel.zopf@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass of chronic liver patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.