Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Официальное название

Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Alcohol Abstinence Intervention
  Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.

Первичные конечные точки

• Feasibility of high-intensity interval training [Срок оценки: Through out the study participation (~3 months)]

Вторичные конечные точки (5)

• Changes in microvascular function [Срок оценки: Baseline and after an 8-week intervention]
• Changes in sympathetic activity [Срок оценки: Baseline and after an 8-week intervention]
• Changes in urine catecholamine levels [Срок оценки: Baseline and after an 8-week intervention]
• Changes in blood pressure [Срок оценки: Baseline and after an 8-week intervention]
• Changes in alcohol intake [Срок оценки: Baseline and after an 8-week intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Texas at Arlington — Arlington

Идентификаторы

NCT: NCT05522075 · 2200-0189 · 4R00AA028537-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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