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RECRUITING
NCT07824089
NA

Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-10-25

Completion Date

2031-12-31

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States