Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT06337656
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06337656
Study Brief:
Protocol Section:
NCT06337656