NCT05397535已完成不适用
Traditional Exercise as Convenient Approach to Improve Health 1-Baduanjin Lower Elevated Blood PreSsure Study
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2022年6月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week
研究概览
简要总结
The aim of this study is to evaluate the effects of Baduanjin on blood pressure in individuals with high normal blood pressure (SBP 130-139 mmHg, and/or DBP 85-89 mmHg), as well as on glucose and lipid metabolism, quality of life, psychology, exercise, immune inflammation, endothelial function, and arterial stiffness.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40 years or older;
- •Systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) <90 mmHg
- •SBP 130-139 mmHg, and/or DBP 85-89 mmHg
排除标准
- •Diagnosis of hypertension (SBP≥140 mmHg, and/or DBP ≥90mmHg）
- •History of cardiovascular diseases, such as coronary heart disease, heart failure, stroke, and peripheral vascular disease
- •Diagnosis of chronic kidney disease, primary aldosteronism, Cushing's syndrome, or pheochromocytoma
- •Newly diagnosed cancer or cancer metastasis within 5 years
- •History of autoimmune disease
- •Having taken antihypertensive drugs or immunoregulators within 2 weeks
- •A long-term need for antihypertensive drugs or immunomoregulators
- •Unable to maintain moderate intensity exercise due to illness or other reasons
- •Pregnant, breastfeeding, or planning to become pregnant within the next 1 year
- •Currently taking regular exercise (at least 30 minutes of moderate-intensity exercise at least three times a week)
- •Allergic to sports bracelets
- •Having participated or been participating in other clinical trials within the last 3 months
- •Unable to use smartphones
- •Other factors that may affect the follow-up, such as alcohol or substance abuse in the last 12 months, planing to live out of town for a long time, or diagnosis of dementia or cognitive impairment which indicates incapability of completing the study
- •Unable to accurately measure blood pressure using the sphygmomanometer provided by the study due to a too large or too small arm circumference
结局指标
主要结局
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 12 week
时间窗: Baseline, 12 week
Change form Baseline ambulatory 24-h systolic blood pressure at 12 week will be measured by ambulatory blood pressure monitoring to investigate the short-term antihypertensive effect of Baduanjin.
Change from baseline ambulatory 24-h systolic blood pressure (mmHg) at 52 week
时间窗: Baseline, 52 week
Change from baseline ambulatory 24-h systolic blood pressure at 52 week will be measured by ambulatory blood pressure monitoring to investigate the long-term antihypertensive effect of Baduanjin.
次要结局
- FBG(mmol/L)(Baseline,12 week,52 week)
- HbA1c(%)(Baseline,12 week,52 week)
- Total scores of The Short-Form-36 Health Survey (SF-36)(Baseline,12 week,52 week)
- SBP(mmHg)(Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week)
- Total scores of Pittsburgh Sleep Quality Index(PSQI)(Baseline,12 week,52 week)
- C-peptide(Baseline,12 week,52 week)
- Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L)(Baseline,12 week,52 week)
- Total scores of Generalized Anxiety Disorder-7(GAD-7)(Baseline,12 week,52 week)
- DBP(mmHg）(Baseline,4 week,8 week,12 weeks,24 week,32 week,52 week)
- Insulin(Baseline,12 week,52 week)
- Total scores of Neck Disability Index(NDI)(Baseline,12 week,52 week)
- Other blood pressure indicators: daytime mean SBP(mmHg), nighttime mean SBP(mmHg), 24-h DBP(mmHg), daytime mean DBP(mmHg), nighttime mean DBP(mmHg)(Baseline,12 week,52 week)
- Total scores of Patient Health Questionnaire-9 items(PHQ-9)(Baseline,12 week,52 week)
- Sit and reach test(cm)(Baseline,12 week,52 week)
研究者
研究点 (1)
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