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

2026年11月10日 更新者：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.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

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.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
30

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

研究联系人备份

学习地点

  • 德国
    • North Rhine-Westphalia
      • Düsseldorf、North Rhine-Westphalia、德国、40225
        • German Diabetes Center
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：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.
其他：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.
无干预：Control group

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

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Change in skeletal muscle function by blood flow restriction training
大体时间：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
大体时间：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

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Change in handgrip strength by blood flow restriction training
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

其他结果措施

其他结果措施

对于临床试验，协议中描述的计划测量用于确定干预/治疗对参与者的影响。对于观察性研究，用于描述疾病或特征模式或与暴露、风险因素或治疗的关联的测量或观察。结果测量的类型包括主要结果测量和次要结果测量。
结果测量
措施说明
大体时间
Change in waist circumference by blood flow restriction training
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
German Diabetes Center

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
Heinrich-Heine University, Duesseldorf

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 研究主任：Michael Roden, Prof. Dr.、Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany
  • 研究主任：Tom Lüdde, Univ.-Prof. Dr、Department of Gastroenterology, Hepatology und Infektiology; University Hospital Düsseldorf; Germany

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2027年1月2日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2029年6月30日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2029年12月31日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年10月21日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月10日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年11月13日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月13日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月10日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • MOVE-TIPS

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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