Long-term of Remote Ischemic Preconditioning and Mindfulness in Patients With Mild Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mean diastolic blood pressure
研究概览
简要总结
According to the latest survey data of China hypertension annual meeting, there are about 300 million patients with hypertension in China, with 10 million new cases of hypertension each year, and there is an obvious trend of younger people. In particular, young and middle-aged people are in a state of mild hypertension for a long time, which causes great pressure on health and medical treatment. At present, the main clinical measures for mild hypertension are to change their eating habits, quit smoking and alcohol, exercise and other lifestyle changes, as well as drug control. For most patients with mild hypertension, drug control is not the best choice. It has been reported that remote ischemic preconditioning (RIPC) may play an effective role in reducing blood pressure .The purpose of this study was to investigate the extent of long-term application of RIPC to reduce blood pressure in patients with mild hypertension.
详细描述
A total of 200 patients with mild hypertension were enrolled in this study, using the method of open label and parallel grouping; 100 cases in the experimental group and 100 cases in the control group, The experimental group was divided into life intervention + drug group and life intervention + ripc group, with 50 patients in each group. The results of 24-hour ambulatory blood pressure monitoring (ABPM) of the three groups were observed before and 3 months after use, including HR, pulse pressure, 24-hour systolic blood pressure, 24-hour diastolic blood pressure, daytime systolic blood pressure, daytime diastolic blood pressure, nighttime systolic blood pressure and nighttime diastolic blood pressure. The changes of renalase, catecholamine, renin, angiotensin - Ⅱ, aldosterone, RhoA kinase, no, adenosine and bradykinin were observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Diagnosed patients with mild hypertension (SBP: 140~159mmHg; DBP: 90~99mmHg)
排除标准
- •Cannot tolerate RIPC
- •Non-essential hypertension
- •patients who have uncontrolled severe arrhythmia, diabetes, electrolyte disturbance
- •patients who have severe organic diseases such acute myocardial infarction, cardiac insufficiency, abnormal renal function, etc.
研究组 & 干预措施
CRIC+MFT
CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
MFT:Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness.
干预措施: CRIC (Device)
CRIC+MFT
CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
MFT:Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness.
干预措施: MFT (Behavioral)
sham CRIC+MFT
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
MFT: Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness.
干预措施: MFT (Behavioral)
sham CRIC+MFT
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
MFT: Twice daily guided audio sessions (synchronized with CRIC timing) emphasizing focused attention on breath and bodily sensations to foster mindful awareness.
干预措施: sham CRIC (Other)
CRIC+sham MFT
CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.
干预措施: CRIC (Device)
CRIC+sham MFT
CRIC :Twice daily for 12 weeks using an automated cuff device. Each 30-minute session consisted of 3 cycles of 6 min inflation (pressure individualized: resting SBP-based increments of +40/+30/+20 mmHg depending on baseline SBP level) followed by 4 min deflation (0 mmHg).
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.
干预措施: sham MFT (Other)
Sham CRIC+Sham MFT
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.
干预措施: sham CRIC (Other)
Sham CRIC+Sham MFT
Sham CRIC: Identical schedule and device; each cycle used fixed 5 min inflation at 60 mmHg (non-ischemic) followed by 5 min deflation.
Sham MFT: Twice daily equivalent-duration audio of looped neutral nature sounds (ocean waves, flowing water, birdsong) without mindfulness instructions.
干预措施: sham MFT (Other)
结局指标
主要结局
Mean diastolic blood pressure
时间窗: 3 months
24-hour Mean diastolic blood pressure measured by Ambulatory blood pressure monitoring
Mean systolic blood pressure
时间窗: 3 months
24-hour Mean systolic blood pressure measured by Ambulatory blood pressure monitoring
次要结局
- Concentration of Renalase(3 months)
- Concentration of adenosine(3 months)
- Concentration of renin(3 months)
- Concentration of catecholamine(3 months)
- Concentration of bradykinin(3 months)