Liver CirrhosisVITALNCT06337656
Vibration Training Approach in Liver Cirrhosis
A study testing Galileo WBV in people with Liver Cirrhosis, run by University Hospital of Cologne.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Galileo WBV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
- Definition of hepatic decompensation
- Occurrence of symptomatic ascites, hepatic encephalopathy, portal hypertensive bleeding (e.g., esophageal variceal bleeding), infection
About this study
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
- 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Galileo WBV
- Keywords
- Sarcopenia
- Medical subject headings
- Liver Cirrhosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galileo WBVDevice
Side-Alternating Whole-Body Vibration Training
| Study group | Role | What they receive |
|---|---|---|
| Galileo Intervention | Experimental | Not described Receives: Device: Galileo WBV |
| Galileo Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Effectiveness on muscle strength
Evaluation of the effectiveness of the intervention in terms of muscle strength using the hand-grip-strength
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Evaluation of the Effectiveness on mobility, in particular the risk of falling
Evaluation of the Effectiveness on mobility, in particular the risk of falling by using the Tinetti test
Measured: 6 months
Evaluation of the Effectiveness on physical function
Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index
Measured: 6 months
Secondary outcomes (3)
Evaluation of Safety of the Training Method
Evaluation of the safety of the training method by recording adverse events
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Dittmann, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337656
- Sponsor's protocol ID
- VITAL_0
- Acronym
- VITAL
- Status last verified
- May 2024
- First submitted
- 3 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06337656
- Acronym / sponsor ID
- VITAL / VITAL_0
- Conditions
- Liver Cirrhosis
- Keywords
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galileo Intervention | Experimental | Device: Galileo WBV |
| Galileo Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galileo WBVSide-Alternating Whole-Body Vibration Training | Device | Galileo Intervention |
Primary outcome
Evaluation of the Effectiveness on muscle strength
Time frame: 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 strength
Time frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength using the leg press
Evaluation of the Effectiveness on muscle strength
Time frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the gait speed
Evaluation of the Effectiveness on muscle strength
Time frame: 6 months
Evaluation of the effectiveness of the intervention in terms of muscle strength measuring the Timed-Up-And-Go-Test
Evaluation of the Effectiveness on muscle mass
Time frame: 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 muscle thickness
Time frame: 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.
Evaluation of the Effectiveness on mobility, in particular the risk of falling
Time frame: 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
Time frame: 6 months
Evaluation of the Effectiveness on physical function by using the Liver-Frailty-Index
3 secondary outcomes
Evaluation of Safety of the Training Method
Time frame: 12 weeks
Health-Related Quality of Life
Time frame: 6 months
Health-Related Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Galileo WBV in people with Liver Cirrhosis, run by University Hospital of Cologne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Effectiveness on muscle strength (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.