Vibration Training Approach in Liver Cirrhosis (VITAL)

May 14, 2024 updated by: Eva Dittmann, University Hospital of Cologne

Influence of an Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients With Liver Cirrhosis and Sarcopenia: A Clinical Pilot Project

  • Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia
  • Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
15

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with confirmed or newly diagnosed compensated liver cirrhosis suffering from sarcopenia (combined decrease in muscle mass and muscle strength)
  • The liver cirrhosis is in a compensated stage.
  • The following etiologies of chronic liver disease are present: chronic hepatitis B infection, chronic hepatitis C infection, alcoholic liver disease, autoimmune hepatitis, cholestatic liver disease (PBC, PSC), or other chronic hepatopathy.
  • Alcohol abstinence of at least 3 months in cases of alcohol-related liver disease.
  • Routine cancer screening for the presence of a liver tumor (HCC surveillance) is routinely performed using MRI or CT scans, as ultrasound assessment is severely limited.
  • Permission from the treating physician to engage in physical activity.
  • Signed informed consent form.

Exclusion Criteria:

  • Non-compliance with inclusion criteria
  • Patients with recent hospitalizations (within the last 3 months) due to gastrointestinal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis
  • Presence of inadequately treated portal hypertension
  • Known chronic liver disease not described in the above groups
  • Alcohol consumption >20 g per day
  • Excessive alcohol consumption during the study period leads to exclusion from the study
  • Substance abuse
  • Taking medications known to affect muscle mass or strength (e.g., Amiodarone, Chloroquine, Macrolides)
  • Taking medications known to cause movement disorders (e.g., Reserpine, Lithium, Cyclosporine A, Dopamine agonists)
  • Patients with unstable cardiovascular diseases: e.g., unstable angina pectoris, uncontrolled hypertension (≥ 160/100 mmHg), uncontrolled diabetes (blood sugar > 250 mg/dl), history of myocardial infarction or stroke
  • Patients with musculoskeletal deformities, symptomatic rheumatoid or osteoarthritis
  • Patients with untreated or newly diagnosed active malignant tumors in history
  • Patients with neuromuscular or neurodegenerative diseases
  • Patients with untreated hernias
  • Patients with symptomatic, known untreated aortic aneurysm, with recent hospitalizations (within the last 6 months)
  • Patients with fractures within the last 12 months
  • Participation in moderate-intensity training programs for more than 2 hours per week
  • Patients who have received chemotherapy at the time of the study or in the past 3 months
  • Other underlying conditions that contraindicate vibration training and/or functional performance tests
  • Circumstances preventing the individual from assessing the nature, scope, and possible consequences of the clinical trial

  • Signs indicating that the subject is likely not to adhere to the study protocol (e.g., lack of cooperation)

    a. Definition of hepatic decompensation

  • Occurrence of symptomatic ascites, hepatic encephalopathy, portal hypertensive bleeding (e.g., esophageal variceal bleeding), infection

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover 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: Galileo Intervention
Device: Galileo WBV
Side-Alternating Whole-Body Vibration Training
No Intervention: Galileo Control

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
Evaluation of the Effectiveness on muscle strength
Time Frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength using the hand-grip-strength
6 months
Evaluation of the Effectiveness on muscle strength
Time Frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength using the leg press
6 months
Evaluation of the Effectiveness on muscle strength
Time Frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the gait speed
6 months
Evaluation of the Effectiveness on muscle strength
Time Frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the Timed-Up-And-Go-Test
6 months
Evaluation of the Effectiveness on muscle mass
Time Frame: 6 months
Evaluation of the Effectiveness on muscle mass through quantification of muscle mass by the skeletal muscle index (SMI) at the level of lumbar vertebral body 3 measured in MRI or CT.
6 months
Evaluation of the Effectiveness on muscle thickness
Time Frame: 6 months
Evaluation of the Effectiveness on muscle mass through quantification of muscle mass by the transverse psoas muscle thickness (TPMT) at the level of lumbar vertebral body 3 measured in MRI or CT.
6 months
Evaluation of the Effectiveness on mobility, in particular the risk of falling
Time Frame: 6 months
Evaluation of the Effectiveness on mobility, in particular the risk of falling by using the Tinetti test
6 months
Evaluation of the Effectiveness on physical function
Time Frame: 6 months
Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index
6 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
Evaluation of Safety of the Training Method
Time Frame: 12 weeks
Evaluation of the safety of the training method by recording adverse events
12 weeks
Health-Related Quality of Life
Time Frame: 6 months
Determination of Health-Related Quality of Life by using the Sarcopenia and Quality of Life (SarQoL®) questionnaire. The Sarcopenia and Quality of Life Questionnaire (SarQoL®), a specific questionnaire for assessing quality of life in sarcopenia, consists of 55 items, grouped into 22 questions rated on a 4-point Likert scale. The questionnaire can be scored up to 100 points, with a higher score reflecting a higher quality of life.
6 months
Health-Related Quality of Life
Time Frame: 6 months
Determination of Health-Related Quality of Life by using the Short Form 36 (SF 36) questionnaire. The possible score ranges from 0 to 100 points, where 0 points represent the greatest possible health impairment, while 100 points indicate no health impairment.
6 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 Hospital of Cologne

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 (Estimated)

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.
June 1, 2024

Primary Completion (Estimated)

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.
October 1, 2025

Study Completion (Estimated)

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.
April 1, 2026

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).
March 3, 2024

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.
March 22, 2024

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.
March 29, 2024

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.
May 16, 2024

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.
May 14, 2024

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.
May 1, 2024

More Information

Terms related to this study

Keywords

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.
  • VITAL_0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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