Exercise Training Decreases Alcohol Consumption and Tissue Injury by an FGF21-dependent Mechanism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• Pedal edema above the ankle or grade 2 pedal edema.
Liver transplant.
Active malignancy.
Gastrointestinal bleed within the previous 4 weeks.
Trial design
Design model
Parallel
Treatments tested in this trial
Endurance Exercise
BehavioralStationary/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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Endurance ExerciseExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Alcohol Consumption Measured by Timeline Follow Back (TLFB)
Alcohol consumption will be assessed using the Timeline Follow Back (TLFB). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Time frame
Baseline to 12 weeksSecondary outcomes
1
Change in Alcohol Cravings Measured by the Penn Alcohol Cravings Scale (PACS)
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS). The primary comparison is change over 12 weeks between the EE+SOC and SOC groups.
Time frame
Baseline to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov