Clinical trial NCT06337656: Vibration Training Approach in Liver Cirrhosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Sarcopenia
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

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

Primary outcomes:
measure: Evaluation of the Effectiveness on muscle strength
timeFrame: 6 months
measure: Evaluation of the Effectiveness on muscle strength
timeFrame: 6 months
measure: Evaluation of the Effectiveness on muscle strength
timeFrame: 6 months
measure: Evaluation of the Effectiveness on muscle strength
timeFrame: 6 months
measure: Evaluation of the Effectiveness on muscle mass
timeFrame: 6 months
measure: Evaluation of the Effectiveness on muscle thickness
timeFrame: 6 months
measure: Evaluation of the Effectiveness on mobility, in particular the risk of falling
timeFrame: 6 months
measure: Evaluation of the Effectiveness on physical function
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of Safety of the Training Method
timeFrame: 12 weeks
measure: Health-Related Quality of Life
timeFrame: 6 months
measure: Health-Related Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: