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

10 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Nina Trinks, Dr.
  • Número de telefone: +49-211-33-82-514
  • E-mail: nina.trinks@ddz.de

Estude backup de contato

Locais de estudo

  • Alemanha
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemanha, 40225
        • German Diabetes Center
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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.
Sem intervenção: Control group

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in skeletal muscle function by blood flow restriction training
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in handgrip strength by blood flow restriction training
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in waist circumference by blood flow restriction training
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

German Diabetes Center

Colaboradores

Heinrich-Heine University, Duesseldorf

Investigadores

  • Diretor de estudo: Michael Roden, Prof. Dr., Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany
  • Diretor de estudo: Tom Lüdde, Univ.-Prof. Dr, Department of Gastroenterology, Hepatology und Infektiology; University Hospital Düsseldorf; Germany

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

2 de janeiro de 2027

Conclusão Primária (Estimado)

30 de junho de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

21 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2026

Primeira postagem (Real)

13 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MOVE-TIPS

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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