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Not Yet Recruiting NCT07936552

Blood Flow Restriction Training After TIPS Placement in Liver Cirrhosis

Conditions: Liver Cirrhosis, TIPS Insertion

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: German Diabetes Center

Location: German Diabetes Center Düsseldorf North Rhine-Westphalia

Summary

The goal of this clinical trial is to investigate whether a 12-week resistance training with mild blood flow restriction following transjugular intrahepatic portosystemic shunt (TIPS) placement, compared with standard care, leads to improvements in muscle mass and muscle function in individuals with liver cirrhosis. The primary focus is on the functional recovery of skeletal muscle following TIPS rather than solely on morphological changes in muscle mass. In addition, people-reported outcomes, clinical trajectories, and metabolic and inflammatory parameters will be assessed to identify potential predictors of functional response to structured physical activity following TIPS.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of liver cirrhosis of any etiology, confirmed by clinical, imaging, or histological criteria * Successful TIPS placement for standard clinical indications (e.g., refractory ascites or variceal bleeding) * Clinical stability 2-6 weeks after TIPS placement, defined as absence of acute complications requiring hospitalization * Child-Pugh class A or B cirrhosis; selected individuals with Child-Pugh C may be included at investigator discretion * No evidence of overt hepatic encephalopathy grade ≥ II at screening * Ability to ambulate independently (with or without walking aid) * Ability to understand study procedures and provide written informed consent * Medical clearance by treating hepatologist to participate in moderate physical activity Exclusion Criteria: * Active or recurrent hepatic encephalopathy grade II or higher within 4 weeks prior to screening * Any contra-indication for MRI scanning * Acute gastrointestinal bleeding within 14 days prior to enrolment * Uncontrolled infection or sepsis * Severe cardiopulmonary disease limiting exercise capacity (e.g., NYHA class III-IV heart failure, unstable coronary artery disease, severe pulmonary hypertension) * Uncontrolled arterial hypertension (\>180/110 mmHg) * Severe orthopaedic, neurologic, or musculoskeletal conditions precluding participation in an exercise program * Advanced hepatocellular carcinoma or other active malignancy with life expectancy \< 6 months * Model for End-Stage Liver Disease (MELD) score \> 22 at screening * Current alcohol or substance abuse interfering with study adherence * Participation in another interventional clinical trial that may interfere with study outcomes * Pregnancy or breastfeeding * Any condition which, in the opinion of the investigator, makes participation unsafe or not in the best interest of the participant * Regular participation in sports or physical activities for more than 2 hours per week * Individuals who do not wish to be informed about unexpected medical findings. * Non-German-speaking

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07936552). StuddyBuddy aggregates publicly available trial information.