Recruiting

Endurance Exercise

Sponsor:

The Cleveland Clinic

Code:

NCT07824089

Conditions

Alcohol Use Disorder (AUD)

Alcohol Related Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endurance Exercise

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder (AUD)

Alcohol Related Liver Disease

Study ID

NCT07824089

Start date

Oct 25, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endurance Exercise

Participants will receive standard of care and complete a 12-week supervised home-based endurance exercise program using a recumbent exercise bike.

no intervention: Standard of Care

Participants will continue usual clinical care and their current pattern of physical activity and will not participate in the structured endurance exercise intervention

Interventions

Endurance Exercise

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.

Primary outcome measure

  • Change in Alcohol Consumption Measured by Timeline Follow Back (TLFB) [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Annette Bellar, PhD

216-445-6268bellara@ccf.org

Research Coordinator

216-445-6268

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Program Manager, PhD

216-445-6268bellara@ccf.org

Principal Investigator:

Srinivasan Dasarathy, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • endurance exercise
  • alcohol consumption
  • alcohol craving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-17.