Dietary Management and Aerobic Exercise on 24-hour Ambulatory Blood Pressure in Subjects with Prehypertension and Drug-naïve Stage 1 Hypertension: Randomized, Single-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in 24-hour ambulatory systolic blood pressure
研究概览
简要总结
This is a multicenter, randomized, single-blinded clinical trial investigating the effect of dietary management and active aerobic exercise training on reduction of 24-hour ambulatory blood pressure in subjects with prehypertension and drug-naïve stage 1 hypertension.
详细描述
Most guidelines recommend lifestyle modifications such as exercise or dietary programs for stage 1 hypertension or prehypertension, before initiation of antihypertensive drug treatment. Epidemiological and observational studies have shown that cardiovascular risk increases progressively from blood pressure levels as low as 115/75 mmHg and that patients with prehypertension or stage 1 hypertension are likely to progress to hypertension requiring medications. From a previous clinical trial, a 12-week aerobic exercise program reduced 24-hour and daytime ambulatory blood pressure in patients with resistant hypertension. Aerobic exercise and DASH (Dietary Approaches to Stop Hypertension) diet are currently recommended in subjects with prehypertension and stage 1 hypertension without a clear randomized, controlled clinical trial. The present trial, thus, seeks to evaluate the effect of dietary management and active aerobic exercise training, preferably moderate-intensity exercise, on 24-hour ambulatory blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years
- •Prehypertension or grade 1 hypertension, defined as a systolic blood pressure of 130 to 159 mm Hg and/or a diastolic blood pressure of 85 to 99 mm Hg
- •Patients without previous use of anti-hypertensive medication
排除标准
- •Patients under anti-hypertensive medications
- •Patients with suspected or confirmed secondary hypertension
- •Patients with abnormal liver function tests (transaminases more than three times the upper limit of normal)
- •Patients without aerobic exercise tolerance
- •Patients under hormone replacement therapy or other steroids
- •Patients with peripheral edemas and/or baseline serum creatinine level above 2.0 mg/dL
- •Patients with medical conditions that potentially affect blood pressure, including neurological disorders, gastrointestinal diseases, or malignancy.
结局指标
主要结局
Change in 24-hour ambulatory systolic blood pressure
时间窗: from baseline to 12 weeks
Change in 24-hour ambulatory systolic blood pressure
Change in office systolic and diastolic blood pressure
时间窗: from baseline to 12 weeks
Change in office systolic and diastolic blood pressure
Change in daytime ambulatory systolic and diastolic blood pressure
时间窗: from baseline to 12 weeks
Change in daytime ambulatory systolic and diastolic blood pressure
Change in 24-hour ambulatory diastolic blood pressure
时间窗: from baseline to 12 weeks
Change in 24-hour ambulatory diastolic blood pressure
Change in nighttime ambulatory systolic and diastolic blood pressure
时间窗: from baseline to 12 weeks
Change in nighttime ambulatory systolic and diastolic blood pressure
次要结局
- Change in arterial stiffness(from baseline to 12 weeks)
- Change in serum renin level(from baseline to 12 weeks)
- Change in serum angiotensin converting enzyme (ACE) level(from baseline to 12 weeks)
- Change in circulating endothelial and inflammatory biomarkers(from baseline to 12 weeks)
研究者
Soon Jun Hong
Professor
Korea University Anam Hospital