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
- 1
- 主要终点
- Change in daytime ambulatory systolic and diastolic 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.
研究组 & 干预措施
Active management group
Active dietary management and aerobic exercise training. Subjects will receive assessment and education of DASH diet (0, 4, and 8 weeks), with active aerobic exercise training (1 hour everyday exercise, at least 5 times per week for 12 weeks) (aerobic exercise education at baseline, 4, and 8 weeks after randomization). Each set of aerobic exercise consists of 10 minutes warm-up, 40 minutes moderate-intensity treadmill trotting, and 10 minutes cooldown. Telephone counseling at 2, 6, and 10 weeks after randomization.
干预措施: Active dietary management and aerobic exercise training. (Other)
Control group
Subjects will not receive education and recommendation of dietary management and aerobic exercise training.
结局指标
主要结局
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 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 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 circulating endothelial and inflammatory biomarkers(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)
研究者
Soon Jun Hong
Professor
Korea University Anam Hospital