Liver Cirrhosis
Conditions
Keywords
Sarcopenia
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.
Interventions
DEVICEGalileo WBV
Side-Alternating Whole-Body Vibration Training
Sponsors
University Hospital of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 physical function | 6 months | Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index |
| Evaluation of the Effectiveness on muscle strength | 6 months | Evaluation of the effectiveness of the intervention in terms of muscle strength using the hand-grip-strength |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 6 months | Determination of Health-Related Quality of Life by using the Sarcopenia and Quality of Life (SarQoL®) questionnaire. The Sarcopenia and Quality of Life Questionnaire (SarQoL®), a specific questionnaire for assessing quality of life in sarcopenia, consists of 55 items, grouped into 22 questions rated on a 4-point Likert scale. The questionnaire can be scored up to 100 points, with a higher score reflecting a higher quality of life. |
| Evaluation of Safety of the Training Method | 12 weeks | Evaluation of the safety of the training method by recording adverse events |
Outcome results
None listed