Vibration Training Approach in Liver Cirrhosis

Not Applicable

Not yet recruiting

• Conditions: Liver Cirrhosis
• Interventions: Device: Galileo WBV

• Registration Number: NCT06337656
• Lead Sponsor: University Hospital of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Study Start: 2024-06-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Galileo Intervention	Galileo WBV	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the Effectiveness on muscle mass	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.
Evaluation of the Effectiveness on muscle thickness	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.
Evaluation of the Effectiveness on physical function	6 months	Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index
Evaluation of the Effectiveness on mobility, in particular the risk of falling	6 months	Evaluation of the Effectiveness on mobility, in particular the risk of falling by using the Tinetti test
Evaluation of the Effectiveness on muscle strength	6 months	Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the Timed-Up-And-Go-Test

Secondary Outcome Measures

Name	Time	Method
Evaluation of Safety of the Training Method	12 weeks	Evaluation of the safety of the training method by recording adverse events
Health-Related Quality of Life	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.