Blood Flow Restriction Training After TIPS Placement in Liver Cirrhosis (MOVE-TIPS)

November 10, 2026 updated by: German Diabetes Center

Can Blood Flow Restriction Training Counteract Sarcopenia After TIPS in People With Liver Cirrhosis?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • German Diabetes Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blood-flow restriction training (BFRT)

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)

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.
No Intervention: Control group

The control group will receive standard care following TIPS placement, including routine clinical follow-up but without training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in skeletal muscle function by blood flow restriction training
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Assessed by the skeletal muscle volume (cm^3) of the thigh and lower leg by magnetic resonance imaging (MRI).
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in handgrip strength by blood flow restriction training
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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).
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Submaximal muscle strength (kg) will be assessed to evaluate changes in muscle function. Strength will be measured using a standardized submaximal strength test.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in muscle strength-to-mass ratio
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in myocellular ATP Content
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in myocellular ATP Synthase Flux
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in waist circumference by blood flow restriction training
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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).
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Assessed by the whole-body, visceral and subcutaneous adipose tissue content (cm^3) by MRI.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Liver volume (cm³) will be measured using MRI to assess volume changes over time.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Liver stiffness (kPa) will be assessed using magnetic resonance elastography (MRE) to evaluate liver tissue stiffness as a non-invasive marker of hepatic fibrosis.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Hepatic lipid content and fatty acid composition (%) will be assessed using MRI to quantify liver fat accumulation (MASLD) and characterize hepatic fatty acid composition.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in hepatic ATP Content
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

The effect of blood flow restriction training on hepatic mitochondrial function will be assessed by measuring hepatic ATP content (mM) using ³¹P-MRS.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
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
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
Change in hepatic ATP Synthase Flux
Time Frame: Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

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.
Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Diabetes Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Heinrich-Heine University, Duesseldorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Roden, Prof. Dr., Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany
  • Study Director: Tom Lüdde, Univ.-Prof. Dr, Department of Gastroenterology, Hepatology und Infektiology; University Hospital Düsseldorf; Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOVE-TIPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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