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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galileo Intervention | Experimental |
| |
| Galileo Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galileo WBV | Device | Side-Alternating Whole-Body Vibration Training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety of the Training Method | Evaluation of the safety of the training method by recording adverse events | 12 weeks |
| Health-Related Quality of Life | 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. |
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Inclusion Criteria:
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
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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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 |
| 6 months |
| Health-Related Quality of Life | 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. | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |