NCT04267471Unknown不适用
Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial
Chengdu University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- average 24-h Systolic Blood Pressure (SBP)
研究概览
简要总结
Several studies investigating Tai Chi for hypertension have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of Tai Chi for essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants aged between 45 to 80 years;
- •participants diagnosed with mild to moderate hypertension, and meet the diagnostic criteria of mild to moderate hypertension according to 2018 Chinese guidelines for the management of hypertension (140≤SBP≤169 and/or 90≤DBP≤109);
- •participants with or without antihypertensive medication;
- •participants with no regular exercise in the past 3 months;
- •participants willing to comply with the study protocol;
- •participants willing to sign informed consent form.
排除标准
- •participants diagnosed with secondary hypertension or refractory hypertension;
- •participants with severe medical visceral condition and chronic diseases, such as diabetes, epilepsy, severe depression or anxiety, psychosis;
- •participants with severe bone and joint diseases or motor dysfunction limit ability to participant exercise;
- •participants with severe cognitive decline (Mini-Mental State Examination score, ≤ 20)
- •participants with weak muscle, poor balance or limited vision that would impede full participation in the study;
- •patients participate in other clinical trials at the same time.
结局指标
主要结局
average 24-h Systolic Blood Pressure (SBP)
时间窗: change from baseline to 12 weeks after intervention
次要结局
- average SBP and average Diastolic Blood Pressure (DBP)(baseline, after intervention(12 week), after follow-up(24 week))
- change of serum concentrations of Nitric Oxide(baseline, after intervention(12 week))
- change of serum concentrations of vascular endothelial growth factor(baseline, after intervention(12 week))
- change of serum concentrations of endothelin(baseline, after intervention(12 week))
- blood pressure measured at home with an upper arm electronic sphygmomanometer(baseline, after intervention(12 week), after follow-up(24 week))
- change of serum concentrations of thromboxane A2(baseline, after intervention(12 week))
- Medical Outcomes Study 36-Item Short Form(baseline, after intervention(12 week))
研究者
研究点 (1)
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