Cardiovascular Effects of lyengar Yoga

描述（由申请人提供）：高血压影响约5000万美国人（占人口的24%）和全球10亿人。高血压是中风、心力衰竭、心肌梗死和肾脏疾病的一个强有力的、持续的和独立的危险因素。今年早些时候，全国联合委员会（JNC7）更新了其关于高血压评估和管理的建议。在JNC7的研究结果中，委员会强调了收缩压（SBP）的重要性，并确定了一种新的高血压前期患者类别，这些患者可以通过有效的生活方式治疗来降低心血管风险。在治疗高血压的生活方式疗法中，迄今为止的大部分研究都是关于饮食（低钠）和活动建议，以及膳食补充剂（大蒜、鱼油）。然而，身心疗法（MBT），如冥想和瑜伽，在控制血压升高方面越来越受欢迎。瑜伽特别有吸引力，因为它的受欢迎程度和可接受性在这个国家迅速增长，也因为它的多模式方法，结合姿势（体式），呼吸（调息）和冥想，莱engar瑜伽是一种特殊形式的经典治疗瑜伽，它依赖于可以标准化和容易复制的严格规范的体式。在这项研究中，我们建议通过一项随机临床试验，在3个特定区域使用强化常规护理比较组，严格和科学地调查结构化12周lyengar瑜伽计划（IYP）对高正常至I期高血压患者的安全性和有效性。1)本研究的主要终点将是量化IYP对通过24小时动态血压监测（ABPM）获得的平均日间收缩压的影响。2)次要终点是比较IYP对心率变异性（HRV）的影响，HRV是衡量心脏自主活动的指标，也是心血管风险的另一个重要替代指标。3)最后，我们将评估IYP对情绪、感知压力和健康相关生活质量的生理和心理指标的影响。通过使用黄金标准的血压和HRV测量方法，并与高技能认证的莱engar瑜伽练习者网络合作，我们将能够估计莱engar瑜伽对收缩压的真正影响，并开始阐明这种影响的机制。该试验还将为RO1提交提供充足的初步数据，以便直接比较莱engar瑜伽与其他非运动mbt（如超觉冥想）、已建立的生活方式建议（如DASH饮食）或积极的药物控制。

DESCRIPTION (provided by applicant): Hypertension affects approximately 50 million Americans (24% of the population) and 1 billion individuals worldwide. Hypertension is a potent, consistent and independent risk factor for stroke, heart failure, myocardial infarction and kidney disease. Earlier this year, the Joint National Committee (JNC7) updated its recommendation on the evaluation and management of hypertension. Among the findings of JNC7, the committee emphasized the importance of systolic blood pressure (SBP) and identified a new category of prehypertensive patients who are candidates for effective lifestyle therapies to reduce their cardiovascular risk. Among lifestyle therapies for elevated blood pressure, much of the research to date has been on dietary (low sodium) and activity advice, and dietary supplements (garlic, fish oils). However, mind-body therapies (MBT) such as mediation and yoga are gaining popularity in managing elevations in blood pressure. Yoga is particularly attractive since its popularity and acceptability is rapidly growing in this country, as well as because its multimodal approach, combining postures (asanas), breathing (pranayama) and meditation, lyengar yoga is a particular form of classical therapeutic yoga which relies on tightly scripted asanas which can be standardized, and easily replicated. For this study, we propose to rigorously and scientifically investigate the safety and efficacy of a structured 12 week lyengar Yoga program (IYP) in patients with high-normal to stage I hypertension via a randomized clinical trial using an enhanced usual care comparator group on 3 specific areas. 1) The primary endpoint of this study will be to quantify the effect of the IYP on mean daytime SBP obtained from 24 hour ambulatory blood pressure monitoring (ABPM). 2) The secondary endpoint will be to compare the effects of IYP on heart rate variability (HRV), a measure of cardiac autonomic activity and another important surrogate marker of cardiovascular risk. 3) Finally, we will assess the effects of IYP on physiologic and psychological measures of mood, perceived stress and health related quality of life. By using gold-standard measures of blood pressure and HRV, and collaborating with a network of highly skilled certified lyengar yoga practitioners, we will be able to estimate the true effect of lyengar yoga on SBP, and begin to elucidate mechanisms of this effect. This trial will also generate ample preliminary data for RO1 submissions to allow direct comparisons of lyengar yoga against other non-movement MBTs such as transcendental meditation, established lifestyle recommendations such as the DASH diet, or active pharmacologic control.