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โ† Trials
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Molecular Mechanism of Exercise in Cirrhosis

RecruitingNAAges 21 Years - 65 YearsAllThe Cleveland Clinic
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In plain words

What the trial is, and whether it could suit you

This study aims to investigate the effects of 12 weeks of resistance or endurance exercise on patients with cirrhosis. Cirrhotic patients are prone to muscle loss (sarcopenia) and ammonia build up due to liver dysfunction. The liver which in healthy patients is able to process ammonia through ureagenesis is unable to do so in cirrhosis and ammonia is taken up either by the brain causing confusion or the skeletal muscle causing muscle loss or sarcopenia. Primary sarcopenia occurs in older individuals and can be mitigated by exercise. Secondary sarcopenia occurs in response to disease such as cancer, chronic kidney disease, multiple sclerosis, and cirrhosis of all etiologies. Resistance exercise is an excellent stimulator for muscle protein synthesis and is widely used to build muscle mass and strength but has little benefit to cardiovascular function. Endurance exercise has shown to be sa

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion * Adult patients age 21-65 years of both genders * Diagnosis of cirrhosis by either liver biopsy, clinical, biochemical or imaging criteria * Child's score 5-10 * Model for End Stage Liver Disease (MELD) score less than 21 * Abstinence from alcohol and/or other recreational drugs for at least 6 months * Absence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass, diabetes mellitus (avoid altered muscle protein metabolism), or use of anticoagulants. * abdominal or liver CT scan within 1 year of enrollment for stratification Exclusion * Active alcohol consumption within 6 weeks of enrollment * Pedal edema (grade 2) above the ankle will be excluded to avoid complications of the muscle biopsy. * Liver transplant * Active Malignancy * Recent GI bleed (4 weeks) * Hepatic Encephalopathy within previous 6 months * Grade 2 or greater active esophageal varices * Active infection * Large Ascites as defined by clinical imaging * Advanced disease cardiac or pulmonary disease * Use of medications affecting muscle protein turnover including corticosteroids or medications used to prevent clotting * Clinical lab values that indicate potential poor clotting as determined by the PI * Inability to obtain informed consent; judged likely to be unable to perform exercise or unlikely to complete the study in the opinion of the investigators * End stage kidney disease as determined by glomerular filtration rate (eGFR) \< 15 ml/min/1.73m2 or dialysis * Patients who in the opinion of the PI are unsafe for exercise (failure to pass stress test)
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What it tests

  • Endurance Training 3 times per week
  • Resistance Exercise
  • Standard of Care
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Where

1 site
Cleveland Clinic
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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