Vibration Training Approach in Liver Cirrhosis (VITAL)

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: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Device: Galileo WBV

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galileo Intervention	Device: Galileo WBV; Side-Alternating Whole-Body Vibration Training
No Intervention: Galileo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Effectiveness on muscle strength	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	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	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	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	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	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	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	Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Safety of the Training Method	Evaluation of the safety of the training method by recording adverse events	12 weeks
Health-Related Quality of Life	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	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

• Sponsor: University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Sarcopenia
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID 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