Korean Life-Style Modification Effects on Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- changes of blood pressure after intervention
研究概览
简要总结
In hypertension, lifestyle modification has been proven to be effective in reducing blood pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal to adding one antihypertensive drug. However, as the dietary pattern is different in the Korean population, the investigators cannot implement the data from Western countries directly to the Korean population. For example, the consumption of dairy products is much smaller in the Korean population when compared to the western population. Therefore, the effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean population is not well defined. In this study, the investigators sought to determine the effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood pressure lowering. The study will be performed on untreated prehypertension patients and uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult age >20
- •If the subject not taken antihypertension, SBP and DBP must be the following result.
- •SBP: 120~159 mmHg , DBP: 80-99 mmHg
- •If the subject taken antihypertension, SBP and DBP must be the following result.
- •SBP: 140-159mmHg ,DBP: 90-99 mmHg
- •BMI 18.5kg/m²~44kg/m²
- •Patients voluntarily agreed to participate in this study
- •Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.
- •(not taking an oral contraceptive)
排除标准
- •If the subject not taken antihypertension, SBP and DBP must be the following result.
- •120>SBP>159 mmHg, 80>DBP>99 mmHg
- •If the subject taken antihypertension, the number of three or more antihypertensive
- •If the subject taken antihypertension, SBP and DBP must be the following result.
- •140>SBP>159 mmHg, 90>DBP>99 mmHg
- •having the target organ disease, the following disease.
- •Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
- •Brain disease: Stroke, TIA, Dementia
- •Kidney disease:
- •Pheripheral artery disease
- •Retinopathy Disease
- •Cancer, Liver disease
- •Regular drinking alcohol above 14 cup of during 1 week.
- •Pregnant women, Women of childbearing age tested positive in HCG result.
- •Pregnant women, Breastfeeding women
- •screening test result CS
- •illiteracy, a foreigner, the person who can't read the consent
- •the person who had participated other study in 3 months.
- •the person who inappropriate to participate
研究组 & 干预措施
general management
干预措施: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention. (Drug)
The treatment group1
Korean DASH diet with sodium reduction intervention
干预措施: Treatment group 1(Dietary intervention) (Dietary Supplement)
The treatment group2
Korean DASH diet with sodium reduction intervention and excersize intervention
干预措施: Treatment group 2(dietary and exercise intervention) (Other)
结局指标
主要结局
changes of blood pressure after intervention
时间窗: after 1 week, 4weeks, 8weeks intervention for each group intervention
The primary outcome will be the difference in sitting brachial systolic blood pressure after 8 weeks intervention. The study population was determined by treatment group 1 will have systolic BP lowering effect of 11.5mmHg with standard deviation of 10.0mmHg and group 2 will have systolic BP lowering effect of 18.0mmHg with standard deviation of 15.0mmHg. with statistical power of 80% and drop out rate of 25%, the number needed was determined to be 32 in the control group, 22 in group 1 and 22 in group 2.
次要结局
未报告次要终点