Can a bike ride curb drinking and heal the liver?
NCT ID NCT07824089
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether a 12-week home cycling program can help adults with alcohol use disorder and alcohol-related liver disease drink less and crave alcohol less. Thirty participants join either the exercise program plus standard care or standard care alone. The study also tracks liver injury markers, fitness, fatigue, and a hormone called FGF21 to see if exercise works through that pathway.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- supervised home endurance exercise on a stationary bike
- What this could lead to
- If exercise helps, it could offer a low-cost, drug-free way to support people cutting back on alcohol and protect their livers.
- What could go wrong
- This is a small 30-person study, so results may not hold up in larger groups. Exercise alone may not be enough to change drinking habits, and some participants may struggle to stick with the program.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * • Adults age 18 years or older, of either sex. * Clinical diagnosis of alcohol use disorder (AUD) / alcohol-related liver disease (ALD). * Meets NIAAA hazardous-drinking criteria: at least 7 drinks/week for women or 14 drinks/week for men for more than 6 months, with ongoing alcohol use within 2 months of evaluation. * MELD score less than 21. * Able to safely participate in exercise testing and endurance exercise. * Able to provide informed consent. * No concurrent renal, cardiac, pulmonary, cerebrovascular, or malignant illness that affects skeletal muscle mass; no diabetes mellitus; and no use of medications that affect skeletal muscle mass/protein turnover as described in the protocol, including anabolic steroids, high-dose corticosteroids, or anticoagulants. Exclusion Criteria: * • Pedal edema above the ankle or grade 2 pedal edema. * Liver transplant. * Active malignancy. * Gastrointestinal bleed within the previous 4 weeks. * Hepatic encephalopathy within the previous 6 months. * Grade 2 or greater active esophageal varices. * Active infection. * Large ascites by clinical and/or imaging criteria. * Advanced cardiac disease (NYHA class 3 or 4) or advanced pulmonary disease (GOLD class 3 or 4). * Use of medications affecting muscle protein turnover, including corticosteroids, or medications used to prevent clotting. * Prior orthopedic surgery or chronic joint pain that, in the opinion of the PI, may inhibit participation. * INR greater than 1.7 or platelet count less than 60,000/mL. * Unable to provide 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 defined as eGFR less than 15 mL/min/1.73 m² or dialysis. * Considered unsafe for exercise in the opinion of the PI. * Failure to pass the exercise stress test.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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