Reducing Blood Pressure in Mid-life Adult Binge Drinkers
2 other identifiers
interventional
55
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
June 1, 2026
May 1, 2026
4.1 years
August 22, 2022
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Through out the study participation (~3 months)
Secondary Outcomes (5)
Changes in microvascular function
Baseline and after an 8-week intervention
Changes in sympathetic activity
Baseline and after an 8-week intervention
Changes in urine catecholamine levels
Baseline and after an 8-week intervention
Changes in blood pressure
Baseline and after an 8-week intervention
Changes in alcohol intake
Baseline and after an 8-week intervention
Study Arms (3)
Exercise Group
EXPERIMENTALBinge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.
Non-exercise Group
ACTIVE COMPARATORBinge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.
Alcohol abstainer/moderate drinker group
NO INTERVENTIONAlcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink
- Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr).
- Subjects who can speak and understand English.
You may not qualify if:
- a history of diabetes, cardiovascular disease, liver, or renal disease
- current or history of smoking and illicit drug use
- blood pressure ≥160/100 mm Hg
- other known traditional cardiovascular disease risks: obesity (BMI≥35 kg/m2), or hyperlipidemia (total cholesterol\>230 mg/dl and/or LDL cholesterol\>160 mg/dl)
- active infection (in the past 2 months)
- a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid)
- unstable body weight (\>5% change during the past 6 months)
- regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week)
- current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at Arlington
Arlington, Texas, 76010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chueh-Lung Hwang, PhD
University of Texas at Arlington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 30, 2022
Study Start
November 21, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- 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
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.