An interventional study of Endurance Exercise in Alcohol Use Disorder (AUD) and Alcohol Related Liver Disease, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
This randomized study will examine whether a 12-week supervised home-based endurance exercise program can reduce alcohol use and alcohol craving in adults with alcohol use disorder (AUD) and alcohol-related liver disease (ALD). Thirty participants will be assigned in a 1:1 ratio to endurance exercise plus standard of care or standard of care alone. Participants in the exercise group will cycle at home three days per week for approximately 60 minutes per session with remote supervision. The study will also evaluate effects of exercise on FGF21, liver injury markers, exercise capacity, physical function, body composition, fatigue, skeletal muscle and mitochondrial function, and exploratory molecular and microbiome measures. The investigators hypothesize that endurance exercise will reduce alcohol use and craving while improving liver and skeletal muscle outcomes, potentially through an FGF21-related mechanism.
Alcohol use disorder is a major driver of continued liver injury in alcohol-related liver disease. Patients with ALD also commonly develop sarcopenia, impaired skeletal muscle function, fatigue, mitochondrial dysfunction, reduced exercise capacity, and physical frailty. Exercise may improve muscle and metabolic function and may also reduce alcohol craving and consumption. FGF21 has been proposed as a mechanistic link among exercise, skeletal muscle, liver injury, metabolism, and alcohol-related behavior.
This is a randomized, controlled, unblinded study of 30 adults with AUD/ALD. Participants will be randomized 1:1 to endurance exercise plus standard of care (EE+SOC) or standard of care alone (SOC). Participants assigned to EE+SOC will complete a 12-week home-based supervised cycling program three days per week, with a target of approximately 60 minutes per session and intensity adjusted for safety, tolerance, and beta-blocker use. Exercise sessions will be remotely monitored, and fitness testing will occur at Cleveland Clinic. Participants in the SOC arm will continue usual clinical care and their usual physical activity without the structured exercise intervention.
The study will assess alcohol consumption and craving; circulating and skeletal muscle FGF21; liver injury measures; exercise capacity and physical performance; body composition; fatigue; skeletal muscle metabolism and mitochondrial function; and exploratory transcriptomic, proteomic, metabolomic, microbiome, amino acid, protein synthesis, TCA intermediate, and cell-signaling responses.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 30 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults age 18 years or older, of either sex.
Exclusion Criteria:
Pedal edema above the ankle or grade 2 pedal edema.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard of care and complete a 12-week supervised home-based endurance exercise program using a recumbent exercise bike.
Behavioral: Endurance Exercise
Participants will continue usual clinical care and their current pattern of physical activity and will not participate in the structured endurance exercise intervention
Stationary/recumbent cycling three days per week for approximately 60 minutes per session for 12 weeks. Exercise intensity is targeted at approximately 60-70% heart rate reserve and adjusted for safety, tolerance, and beta-blocker use. Sessions are remotely monitored by the study team. Participants who cannot exercise continuously may use rest breaks and complete the prescribed exercise within the limits described in the protocol.
Change in Alcohol Consumption Measured by Timeline Follow Back (TLFB)
Alcohol consumption will be assessed using the Timeline Follow Back (TLFB). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Time frame: Baseline to 12 weeks
Change in Alcohol Cravings Measured by the Penn Alcohol Cravings Scale (PACS)
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Time frame: Baseline to 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2031, 62 months later.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 62 months is above that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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