Effects of exercise on patients with cirrhosis
Molecular Mechanism of Exercise in Cirrhosis
This study tests if a 12-week exercise program can help people with cirrhosis gain muscle and feel healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05982769 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21-65 with a diagnosis of cirrhosis and a Child's score between 5-10.
Not a fit: Patients with active alcohol consumption, recent GI bleeding, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance muscle mass and overall health in patients with cirrhosis, potentially improving their quality of life.
How similar studies have performed: While exercise has been shown to benefit muscle health in various conditions, this specific approach in cirrhosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Srinivasan Dasarathy, MD
- Email: dasaras@ccf.org
- Phone: 216-318-7010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.