30 Participants NeededMy employer runs this trial

Endurance Exercise for Problem Drinking

AB
RC
Overseen ByResearch Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SD

Srinivasan Dasarathy, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults who have alcohol use disorder and alcohol-related liver disease. Participants should be able to safely exercise at home and follow a supervised program.

Inclusion Criteria

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
I have been diagnosed with alcohol use disorder or alcohol-related liver disease.
I do not have other serious illnesses that affect my muscle mass.
See 6 more

Exclusion Criteria

Considered unsafe for exercise in the opinion of the PI
Failure to pass the exercise stress test
I currently have an active cancer.
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • Endurance Exercise

Trial Overview

The study compares a 12-week, home-based endurance cycling program plus standard care versus standard care alone to see if exercise can reduce drinking and improve health in people with problem drinking and liver issues.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Endurance ExerciseExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+