Vibration Training Approach in Liver Cirrhosis (VITAL)

University Hospital of Cologne

Status: Not yet enrolling

Conditions: Liver Cirrhosis

Treatments: Device: Galileo WBV

Study type: Interventional

Funder types: Other

Identifiers

NCT06337656

VITAL_0

Details and patient eligibility

About

• 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Galileo Intervention

Experimental group

Treatment:

Device: Galileo WBV

Galileo Control

No Intervention group