Blood Flow Restriction Training After TIPS Placement in Liver Cirrhosis (MOVE-TIPS)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Nina Trinks, Dr.
- 電話番号：+49-211-33-82-514
- メール：nina.trinks@ddz.de
研究連絡先のバックアップ
- 名前：Sofia Gaitan
- 電話番号：+49-211-3382-253
- メール：sofia.gaitan@ddz.de
研究場所
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North Rhine-Westphalia
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Düsseldorf、North Rhine-Westphalia、ドイツ、40225
- German Diabetes Center
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コンタクト：
- Michael Roden, Prof. Dr.
- 電話番号：00492113382201
- メール：Michael.Roden@ddz.de
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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. |
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介入なし：Control group
The control group will receive standard care following TIPS placement, including routine clinical follow-up but without training. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in skeletal muscle function by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in skeletal muscle mass by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in handgrip strength by blood flow restriction training
時間枠：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
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Change in isometric muscle strength by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in submaximal strength by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in functional exercise capacity by blood flow restriction training
時間枠：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
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Change in lower extremity physical performancee by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in muscle strength-to-mass ratio
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in myocellular ATP Content
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in myocellular ATP Synthase Flux
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in waist circumference by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
|
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Change in fat mass by blood flow restriction training
時間枠：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
|
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Change in fat- free mass by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in adipose tissue distribution by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in liver volumen by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in liver stiffness by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in hepatic lipid content and fatty acid composition by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in hepatic ATP Content
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
|
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Change in liver disease-specific quality of life by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in quality of life by blood flow restriction training
時間枠：Before and after 12 weeks of training as well as after 12 weeks (24 weeks) of detraining
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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
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Change in hepatic ATP Synthase Flux
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Michael Roden, Prof. Dr.、Institute for Clinical Diabetology, German Diabetes Center (DDZ), Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany
- スタディディレクター：Tom Lüdde, Univ.-Prof. Dr、Department of Gastroenterology, Hepatology und Infektiology; University Hospital Düsseldorf; Germany
出版物と役立つリンク
一般刊行物
- European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
- Ebadi M, Bhanji RA, Mazurak VC, Montano-Loza AJ. Sarcopenia in cirrhosis: from pathogenesis to interventions. J Gastroenterol. 2019 Oct;54(10):845-859. doi: 10.1007/s00535-019-01605-6. Epub 2019 Aug 7.
- Hey P, Chapman B, Wong D, Gow P, Testro A, Terbah R, Sinclair M. Transjugular intrahepatic portosystemic shunt insertion improves muscle mass but not muscle function or frailty measures. Eur J Gastroenterol Hepatol. 2023 Sep 1;35(9):997-1003. doi: 10.1097/MEG.0000000000002592. Epub 2023 Jun 16.
- de Brito Nunes M, Delgado MG, Bosch J, Berzigotti A. Outcomes after TIPS in patients with cirrhosis and sarcopenia: A systematic review and meta-analysis. JHEP Rep. 2025 Nov 29;8(2):101699. doi: 10.1016/j.jhepr.2025.101699. eCollection 2026 Feb.
- Trinks N, Gancheva S, Putzer J, Schon M, Huttasch M, Pafili K, Mastrototaro L, Dewidar B, Kupriyanova Y, Herder C, Strassburger K, Zaharia OP, Ruppert PMM, Kersten S, Hoeks J, Trenkamp S, Schrauwen-Hinderling V, Schrauwen P, Roden M, Pesta DH. Blood-flow restriction resistance training improves skeletal muscle mitochondrial capacity and cardiovascular risk factors in type 2 diabetes. Cell Metab. 2026 Apr 7;38(4):812-823.e6. doi: 10.1016/j.cmet.2025.12.016. Epub 2026 Jan 28.
- Saatmann N, Zaharia OP, Loenneke JP, Roden M, Pesta DH. Effects of Blood Flow Restriction Exercise and Possible Applications in Type 2 Diabetes. Trends Endocrinol Metab. 2021 Feb;32(2):106-117. doi: 10.1016/j.tem.2020.11.010.
研究記録日
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研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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最初に提出
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