Status:
RECRUITING
Molecular Mechanism of Exercise in Cirrhosis
Lead Sponsor:
The Cleveland Clinic
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05982769
Start Date
June 1 2023
End Date
August 10 2027
Last Update
November 25 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195