An interventional study of Exercise Training and Alcohol Abstinence Intervention in Alcohol Drinking, Binge Drinking and Blood Pressure, sponsored by The University of Texas at Arlington. Recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by The University of Texas at Arlington · Not applicable, Interventional, and Prevention
This study has two phases:
Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers.
Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers
During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's planned enrollment of 55 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →The University of Texas at Arlington is the lead sponsor of 39 studies on the registry; 12 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Compared within Binge Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.
Behavioral: Exercise Training · Behavioral: Alcohol Abstinence Intervention
Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.
Behavioral: Alcohol Abstinence Intervention
Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.
Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.
Feasibility of high-intensity interval training
Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts
Time frame: Through out the study participation (~3 months)
Changes in microvascular function
A small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured.
Time frame: Baseline and after an 8-week intervention
Changes in sympathetic activity
A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).
Time frame: Baseline and after an 8-week intervention
Changes in urine catecholamine levels
Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)
Time frame: Baseline and after an 8-week intervention
Changes in blood pressure
Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.
Time frame: Baseline and after an 8-week intervention
Changes in alcohol intake
Questionnaires will be used to determine alcohol intake.
Time frame: Baseline and after an 8-week intervention
Plan to share: Yes — We will submit to the NIMH Data Archive human subjects' data that were collected as part of the "Research Project" including microvascular function, sympathetic activity, and blood pressure. These data will be made accessible to authorized users for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development.
Time frame: Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date (04/30/2026).
Access criteria: Submit a Data Access Request to NDA and get approval
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 49 months is above that.
How these figures are worked out, and which studies are left out of them.
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The University of Texas at Arlington