Vibration Training Approach in Liver Cirrhosis

NCT ID: NCT06337656

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-04-01

Brief Summary

• 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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galileo Intervention

Group Type: EXPERIMENTAL

Galileo WBV

Intervention Type: DEVICE

Side-Alternating Whole-Body Vibration Training

Galileo Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Galileo WBV

Side-Alternating Whole-Body Vibration Training

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Eva Dittmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

VITAL_0

Identifier Type: -

Identifier Source: org_study_id