Alcohol Use Disorder study: Endurance Exercise
Official title Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism
ClinicalTrials.gov ID: NCT07824089
What this study is testing
- What it's testing
- The study wants to know whether regular endurance exercise can lower alcohol consumption and cravings, and improve liver and muscle health in people with alcohol‑related liver disease.
- Who it's for
- Adults who have alcohol use disorder and alcohol‑related liver disease.
- What's involved
- Participants are randomly assigned to either a supervised home‑based cycling program (about 60 minutes, three times a week) plus usual care, or to usual care alone. The exercise is monitored remotely, and health measurements are taken throughout the study.
- Time commitment
- The trial lasts 12 weeks and includes regular remote check‑ins and study visits for assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- MELD score less than 21.
- Able to safely participate in exercise testing and endurance exercise.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.