An interventional study of Blood-flow restriction training (BFRT) in Liver Cirrhosis and TIPS Insertion, sponsored by German Diabetes Center. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by German Diabetes Center · Not applicable, Interventional, and Basic science
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Among 82 studies in Liver Cirrhosis with a site in Germany — 24 open to participants now, 27 under way, 2 of them phase 3. Liver Cirrhosis · Germany.
Among the 82 studies in Liver Cirrhosis with a site in Germany, this one is the 34th largest by planned enrollment of the 43 interventional ones that give a count, is one of 2 that started in 2027, is one of 12 with no phase, reaches primary completion later than 22 of the 26 other live ones, and was the 82nd registered.
1,301 studies on the registry are indexed under Liver Cirrhosis; 341 are open to participants now.
Browse Liver Cirrhosis studies →24 of the 82 studies in Liver Cirrhosis with a site in Germany are open now. Recruiting first, the newest first:
University Hospital Muenster · Sites in Germany
Ages 18+
University Medical Center Groningen · Sites in Germany, Austria, Belgium and 7 more countries
Ages 18+
Hannover Medical School · Sites in Germany
Ages 18–99 · Healthy volunteers
University Hospital Freiburg · Sites in Germany
Ages 18–80
Boehringer Ingelheim · Sites in Germany, United States, Argentina and 34 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 208 Liver Cirrhosis studies recruiting now, 101 (49%) set no upper age limit and 66 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 20 · Phase 3 8 · Phase 4 3
First in 2000; this study’s year is marked. 2 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 78 across 742 interventional studies indexed under Liver Cirrhosis.
Median enrollment 110 across the 43 interventional studies, 200 across the 37 observational. Of the 51 that completed or were terminated, 18 (35%) have results posted.
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35 of 82 have an industry lead sponsor. The 10 most frequent:
German Diabetes Center is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
German Diabetes Center has 2 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Liver Cirrhosis with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05500222Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) | 2026-12 |
| NCT07585890University Medical Center GroningenEstablishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe | 2026-12-31 |
| NCT04613921European Foundation for Study of Chronic Liver FailureLiver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs | 2026-12-31 |
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Among the 82 studies in Liver Cirrhosis with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
People with liver cirrhosis frequently develop complications such as refractory ascites and variceal bleeding, for which transjugular intrahepatic portosystemic shunt (TIPS) placement is an established therapeutic option to decompress portal hypertension and improve symptom burden. However, although TIPS addresses hemodynamic derangements, it does not reliably ameliorate the profound functional impairment and muscle wasting (sarcopenia) that characterize advanced chronic liver disease. Physical exercise and structured activity have emerged as promising non-pharmacological interventions to counteract sarcopenia, improve functional capacity, and enhance health-related quality of life in people with liver disease. Although observational studies suggest that skeletal muscle mass may increase in the months following TIPS placement, these changes are frequently not accompanied by proportional improvements in muscle strength or functional capacity. This dissociation highlights the concept of impaired muscle quality in advanced liver disease and indicates that hemodynamic improvement alone may be insufficient to restore physical function after TIPS. Given the unmet clinical need to address persistent functional decline after TIPS placement and the strong association of sarcopenia with adverse outcomes, there is a compelling rationale to investigate whether a structured, supervised exercise intervention initiated after TIPS placement can improve objective measures of functional capacity, muscle health, and clinical outcomes.
Of note, conventional resistance training (CREST) involves high mechanical loads (\~70% of one-repetition maximum [1-RM]) and may not be suitable for all people after TIPS placement, especially for those with advanced sarcopenia. In recent years, blood flow restriction training (BFRT) has emerged as a promising alternative training method in healthy individuals and athletes, resulting in muscular adaptations comparable to CREST, but at substantially lower training intensities (e.g., \~30% 1-RM). Specifically, during BFRT, a cuff is placed proximally on the exercising limb and inflated to an individualized pressure corresponding to up to \~80% arterial inflow restriction with complete venous occlusion.
Therefore, the present study aims to prove whether a 12-week BFRT intervention not only increases muscle mass but even more improves muscle function in people after TIPS placement. This will be done by evaluating both physiological and person-centered endpoints, thereby providing a scientific basis for integrating BFRT targeted physical activity into the standard care pathway for individuals with cirrhosis undergoing TIPS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Resistance training with low loads (30% 1-RM) in combination with a brief occlusion of venous blood flow using a tourniquet while exercising.
Other: Blood-flow restriction training (BFRT)
The control group will receive standard care following TIPS placement, including routine clinical follow-up but without training.
Training program: After 10 minutes of warm-up the participant performs four exercises with BFRT for the lower extremities. The intensity is about 30% of 1-RM.
Change in skeletal muscle function by blood flow restriction training
Assessed by the phosphocreatine (PCr) recovery half-time by phosphorus-31 magnetic resonance spectroscopy (³¹P-MRS) . The PCr recovery serves is an indicator of the skeletal muscle oxidative capacity, with shorter recovery times reflecting better muscle function.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in skeletal muscle mass by blood flow restriction training
Assessed by the skeletal muscle volume (cm\^3) of the thigh and lower leg by magnetic resonance imaging (MRI).
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in handgrip strength by blood flow restriction training
Handgrip strength (kg) will be assessed using a hand dynamometer. Measurements will be performed three times on each hand. The highest value obtained from the three trials for each hand will be used as the final outcome, reported separately for the right and left hand in kilograms (kg).
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in isometric muscle strength by blood flow restriction training
Isometric muscle strength will be assessed using a standardized strength assessment protocol and measured in Newtons (N). Two measurements will be performed, and the highest value will be used as the final outcome. Higher values indicate greater isometric muscle strength, with positive changes from baseline indicating improvements in muscle strength.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in submaximal strength by blood flow restriction training
Submaximal muscle strength (kg) will be assessed to evaluate changes in muscle function. Strength will be measured using a standardized submaximal strength test.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in functional exercise capacity by blood flow restriction training
Six-Minute Walk Test (6MWT; m) will be performed to assess functional exercise capacity. The total distance walked in six minutes on a standardized walking course will be recorded in meters, with longer distances indicating better functional capacity.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in lower extremity physical performancee by blood flow restriction training
Short Physical Performance Battery (SPPB; score: 0-12) will be performed to assess changes in lower extremity physical performance. The assessment comprises three components: standing balance, gait speed (4-meter walk test), and lower extremity strength (five-repetition chair stand test). Higher scores indicate better physical performance.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in muscle strength-to-mass ratio
The muscle strength-to-mass ratio will be calculated by dividing muscle strength (kg) by skeletal muscle volume (cm³). The resulting ratio (kg/cm³) represents muscle strength relative to skeletal muscle volume.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in myocellular ATP Content
The effect of blood flow restriction training on myocellular mitochondrial function will be assessed by measuring myocellular adenosine triphosphate (ATP) content (mM) using ³¹P-MRS.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in myocellular ATP Synthase Flux
The effect of blood flow restriction training on myocellular mitochondrial function will also be assessed by measuring myocellular ATP synthase flux (mM/min) using ³¹P-MRS.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in waist circumference by blood flow restriction training
Waist circumference (cm) will be assessed using a standardized measurement protocol. One measurement will be performed, and the value will be recorded as the final outcome in centimeters (cm).
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in fat mass by blood flow restriction training
Fat mass index (FMI; kg/m²) will be calculated by dividing total fat mass (kg), assessed using the BodPod, by height squared (m²). The resulting FMI value will be reported in kg/m².
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in fat- free mass by blood flow restriction training
Fat-free mass index (FFMI; kg/m²) will be calculated by dividing fat-free mass (kg), assessed using the BodPod, by height squared (m²). The resulting FFMI value will be reported in kg/m².
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in adipose tissue distribution by blood flow restriction training
Assessed by the whole-body, visceral and subcutaneous adipose tissue content (cm\^3) by MRI.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in liver volumen by blood flow restriction training
Liver volume (cm³) will be measured using MRI to assess volume changes over time.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in liver stiffness by blood flow restriction training
Liver stiffness (kPa) will be assessed using magnetic resonance elastography (MRE) to evaluate liver tissue stiffness as a non-invasive marker of hepatic fibrosis.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in hepatic lipid content and fatty acid composition by blood flow restriction training
Hepatic lipid content and fatty acid composition (%) will be assessed using MRI to quantify liver fat accumulation (MASLD) and characterize hepatic fatty acid composition.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in hepatic ATP Content
The effect of blood flow restriction training on hepatic mitochondrial function will be assessed by measuring hepatic ATP content (mM) using ³¹P-MRS.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in liver disease-specific quality of life by blood flow restriction training
Chronic Liver Disease Questionnaire (CLDQ), which evaluates liver disease-specific quality of life across six domains, with higher scores indicating better health-related quality of life.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in quality of life by blood flow restriction training
Short-Form (SF) 36 physical component score, which assesses health-related quality of life across eight domains-physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health-with scores transformed to a 0-100 scale, where higher scores indicate better health and functioning.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in hepatic ATP Synthase Flux
The effect of blood flow restriction training on hepatic mitochondrial function will also be assessed by measuring hepatic ATP synthase flux (mM/min) using ³¹P-MRS.
Time frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Start is estimated for Jan 2027; primary completion for Jun 2029, 29 months later.
Of 206 non-industry interventional studies with no phase under Liver Cirrhosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 73. This study's planned 29 months is below that.
Counting every sponsor, half of 215 studies reached it within 32 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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German Diabetes Center