Exercise for Liver Cirrhosis
Trial Summary
What is the purpose of this trial?
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 safe in cirrhosis however there is no set prescription for cirrhosis as there is for other disease. Endurance exercise is known to promote improved cardiovascular health, improve fatigue, and generates less ammonia build up than resistance exercise. In patients with low muscle mass it is possible that endurance exercise alone will be enough to improve muscle mass. There have been few studies on exercise and cirrhosis, those that exist have shown benefits with endurance exercise. However there are even more limited studies on resistance exercise and few to no studies on the molecular mechanisms behind exercise in cirrhosis. Study visits are described fully in the protocol and consent form. After passing a screening visit patients will undergo a maximal exercise/fitness test (pre-baseline test) and other body composition measurements. After the screening and pre-baseline visit randomization will occur (2:2:1 endurance, resistance, or SOC) arrangements will be made to have the appropriate exercise equipment given to patients. Once the exercise equipment has arrived a baseline study visit will occur. After the baseline visit the endurance exercise group will cycle 3 days per week for 60 minutes under the supervision of the study team. The resistance exercise group will perform a whole body resistance workout 2 days per week for approximately 60 minutes under the supervision of a study team member. Patients in all groups will have the fitness test repeated at weeks 4, 8 and 12. After the 12 weeks of exercise the baseline visits will be repeated and after 2 weeks patients will complete one final fitness test to examine the effects of de-training.
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications that affect muscle protein turnover, like corticosteroids, or medications used to prevent clotting. If you are on these medications, you may need to stop them to participate in the trial.
What data supports the effectiveness of the treatment for liver cirrhosis?
Research on people with multiple sclerosis (MS) shows that exercise, including resistance and endurance training, can improve muscle strength, quality of life, and reduce fatigue. While this is not directly about liver cirrhosis, it suggests that similar exercise programs might help improve physical health and well-being in other conditions.12345
Is exercise safe for people with liver cirrhosis?
How does the exercise treatment for liver cirrhosis differ from other treatments?
The exercise treatment for liver cirrhosis is unique because it focuses on improving physical capacity, muscle health, and quality of life through endurance and resistance training, rather than relying on medication. This approach is promising as it addresses issues like frailty and sarcopenia (muscle loss) that are common in cirrhosis, and it can be tailored to individual needs, making it a novel addition to standard care.67111213
Research Team
Eligibility Criteria
This trial is for adults aged 40-65 with cirrhosis who haven't drunk alcohol or used recreational drugs in the last 6 months. They should have a Child's score of 5-10, MELD score under 21, and no severe illnesses or medications that affect muscle mass. People with advanced heart/lung disease, recent heavy drinking, certain medication use, active cancer/infection/ascites/encephalopathy, poor clotting ability, end-stage kidney disease or those unlikely to complete the study are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-baseline
Participants undergo a maximal exercise/fitness test and body composition measurements
Treatment
Participants engage in 12 weeks of either endurance or resistance exercise
Follow-up
Participants complete a final fitness test to examine the effects of de-training
Treatment Details
Interventions
- Endurance Training (Behavioural Intervention)
- Resistance Exercise (Behavioural Intervention)
- Standard of Care (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
David Peter
The Cleveland Clinic
Chief Medical Officer
MD, board-certified in Hospice and Palliative Medicine
Tomislav Mihaljevic
The Cleveland Clinic
Chief Executive Officer since 2018
MD from University of Zagreb School of Medicine