Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT06337656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vibration Training Approach in Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Effectiveness on muscle strength', 'timeFrame': '6 months', 'description': 'Evaluation of the effectiveness of the intervention in terms of muscle strength using the hand-grip-strength'}, {'measure': 'Evaluation of the Effectiveness on muscle strength', 'timeFrame': '6 months', 'description': 'Evaluation of the effectiveness of the intervention in terms of muscle strength using the leg press'}, {'measure': 'Evaluation of the Effectiveness on muscle strength', 'timeFrame': '6 months', 'description': 'Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the gait speed'}, {'measure': 'Evaluation of the Effectiveness on muscle strength', 'timeFrame': '6 months', 'description': 'Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the Timed-Up-And-Go-Test'}, {'measure': 'Evaluation of the Effectiveness on muscle mass', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Evaluation of the Effectiveness on muscle thickness', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Evaluation of the Effectiveness on mobility, in particular the risk of falling', 'timeFrame': '6 months', 'description': 'Evaluation of the Effectiveness on mobility, in particular the risk of falling by using the Tinetti test'}, {'measure': 'Evaluation of the Effectiveness on physical function', 'timeFrame': '6 months', 'description': 'Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Safety of the Training Method', 'timeFrame': '12 weeks', 'description': 'Evaluation of the safety of the training method by recording adverse events'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': '* 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\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed or newly diagnosed compensated liver cirrhosis suffering from sarcopenia (combined decrease in muscle mass and muscle strength)\n* The liver cirrhosis is in a compensated stage.\n* 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.\n* Alcohol abstinence of at least 3 months in cases of alcohol-related liver disease.\n* 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.\n* Permission from the treating physician to engage in physical activity.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Non-compliance with inclusion criteria\n* Patients with recent hospitalizations (within the last 3 months) due to gastrointestinal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis\n* Presence of inadequately treated portal hypertension\n* Known chronic liver disease not described in the above groups\n* Alcohol consumption \\>20 g per day\n* Excessive alcohol consumption during the study period leads to exclusion from the study\n* Substance abuse\n* Taking medications known to affect muscle mass or strength (e.g., Amiodarone, Chloroquine, Macrolides)\n* Taking medications known to cause movement disorders (e.g., Reserpine, Lithium, Cyclosporine A, Dopamine agonists)\n* 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\n* Patients with musculoskeletal deformities, symptomatic rheumatoid or osteoarthritis\n* Patients with untreated or newly diagnosed active malignant tumors in history\n* Patients with neuromuscular or neurodegenerative diseases\n* Patients with untreated hernias\n* Patients with symptomatic, known untreated aortic aneurysm, with recent hospitalizations (within the last 6 months)\n* Patients with fractures within the last 12 months\n* Participation in moderate-intensity training programs for more than 2 hours per week\n* Patients who have received chemotherapy at the time of the study or in the past 3 months\n* Other underlying conditions that contraindicate vibration training and/or functional performance tests\n* Circumstances preventing the individual from assessing the nature, scope, and possible consequences of the clinical trial\n* Signs indicating that the subject is likely not to adhere to the study protocol (e.g., lack of cooperation)\n\n a. Definition of hepatic decompensation\n* Occurrence of symptomatic ascites, hepatic encephalopathy, portal hypertensive bleeding (e.g., esophageal variceal bleeding), infection'}, 'identificationModule': {'nctId': 'NCT06337656', 'acronym': 'VITAL', 'briefTitle': 'Vibration Training Approach in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'VITAL_0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Galileo Intervention', 'interventionNames': ['Device: Galileo WBV']}, {'type': 'NO_INTERVENTION', 'label': 'Galileo Control'}], 'interventions': [{'name': 'Galileo WBV', 'type': 'DEVICE', 'description': 'Side-Alternating Whole-Body Vibration Training', 'armGroupLabels': ['Galileo Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eva Dittmann', 'investigatorAffiliation': 'University Hospital of Cologne'}}}}