Cirrhosis, LiverNCT05982769
Molecular Mechanism of Exercise in Cirrhosis
A study testing Endurance Training 3 times per week and Resistance Exercise in people with Cirrhosis, Liver, run by The Cleveland Clinic at 1 site in United States.
Trial 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 to liver dysfunction. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Endurance Training 3 times per week and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 10 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 22Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annette Bellar contact
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Annette Bellar
About this study
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.
- Conditions
- Cirrhosis, Liver
- Being tested
- Endurance Training 3 times per week, Resistance Exercise, Standard of Care
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance Training 3 times per weekBehavioural
endurance training will be performed from home 3 times per week under the supervision of the research team.
Resistance ExerciseBehavioural
resistance training will be performed from home 2 times per week under the supervision of the research team.
Standard of CareBehavioural
continue usual activity
| Study group | Role | What they receive |
|---|---|---|
| Endurance Arm | Experimental | Not described Receives: Behavioral: Endurance Training 3 times per week |
| Resistance | Experimental | Not described Receives: Behavioral: Resistance Exercise |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass over time
Measured: day 0 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jun 2023
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982769
- Sponsor's protocol ID
- 21-090
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanism of Exercise in Cirrhosis
- ClinicalTrials.gov ID
- NCT05982769
- Acronym / sponsor ID
- 21-090
- Conditions
- Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endurance Arm | Experimental | Behavioral: Endurance Training 3 times per week |
| Resistance | Experimental | Behavioral: Resistance Exercise |
| Standard of Care | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance Training 3 times per weekendurance training will be performed from home 3 times per week under the supervision of the research team. | Behavioural | Endurance Arm |
| Resistance Exerciseresistance training will be performed from home 2 times per week under the supervision of the research team. | Behavioural | Resistance |
| Standard of Carecontinue usual activity | Behavioural | Standard of Care |
Primary outcome
Change in muscle mass over time
Time frame: day 0 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annette Bellar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Training 3 times per week and Resistance Exercise in people with Cirrhosis, Liver, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srinivasan Dasarathy, MD (216-318-7010, dasaras@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass over time (time frame: day 0 and day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.