Reducing Blood Pressure in Mid-life Adult Binge Drinkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Training, Alcohol Abstinence Intervention.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Binge Drinking, Blood Pressure, Alcohol Abstinence. Basic parameters: 50 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity
Overview
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
Detailed description
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.
Interventions
- Behavioral Exercise Training
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. - Behavioral Alcohol Abstinence Intervention
Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.
Primary outcome measures
- Feasibility of high-intensity interval training [Time frame: Through out the study participation (~3 months)]
Secondary outcome measures (5)
- Changes in microvascular function [Time frame: Baseline and after an 8-week intervention]
- Changes in sympathetic activity [Time frame: Baseline and after an 8-week intervention]
- Changes in urine catecholamine levels [Time frame: Baseline and after an 8-week intervention]
- Changes in blood pressure [Time frame: Baseline and after an 8-week intervention]
- Changes in alcohol intake [Time frame: Baseline and after an 8-week intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Texas at Arlington — Arlington
Identifiers
NCT: NCT05522075 · 2200-0189 · 4R00AA028537-03