Vibration Training Approach in Liver Cirrhosis

NCT06337656 | Not Yet Recruiting

• 1 other identifier: VITAL_0
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Keywords

Sarcopenia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Evaluation of Safety of the Training Method

  12 weeks

• Health-Related Quality of Life

  6 months

• Health-Related Quality of Life

  6 months

Study Arms (2)

Galileo Intervention

EXPERIMENTAL

Device: Galileo WBV

Galileo Control

NO INTERVENTION

Interventions

Galileo WBV DEVICE

Side-Alternating Whole-Body Vibration Training

Galileo Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital of Cologne: lead

MeSH Terms

Conditions

Liver Cirrhosis; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 29, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05