Effects of exercise on patients with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of 12 weeks of resistance and endurance exercise on patients suffering from cirrhosis, a condition that often leads to muscle loss and ammonia buildup due to liver dysfunction. The research aims to determine how these exercise modalities can mitigate sarcopenia, a common complication in cirrhotic patients. Participants will engage in structured exercise programs three times a week while receiving standard care. The study will assess the physiological changes and potential benefits of exercise in improving muscle mass and overall health in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Srinivasan Dasarathy, MD
• Email: dasaras@ccf.org
• Phone: 216-318-7010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.