Restorative Yoga for Therapy of the Metabolic Syndrome (RHYTHMS) study

描述（由申请人提供）：代谢异常，包括内脏肥胖、胰岛素抵抗、高血糖症、高血压和血脂异常，共同发生，并与热量摄入过多和体力活动不足相关。大约66%的美国成年人超重，几乎一半的肥胖者符合“代谢综合征”的标准，这大大增加了患糖尿病和心血管疾病的风险。生活方式和行为干预可以降低这些风险，但许多代谢风险增加的人发现很难实现和维持减肥和增加体力活动。瑜伽是一种古老的自我意识系统，结合了身体姿势，呼吸和精神焦点的使用。最近一项关于瑜伽对心血管危险因素影响的综述发现，代谢危险因素发生了有益的变化。我们已经完成了两个恢复性瑜伽的试点试验，这是一种使用支撑姿势来诱导完全放松状态而不会肌肉紧张的瑜伽。在一项针对超重和活动不足的代谢综合征患者的随机对照试点试验中，我们发现向代谢综合征患者教授恢复性瑜伽是可行的，并且坚持和保持都很好。每周进行10周的瑜伽训练后，瑜伽组的体重、腰围和血压都有改善的趋势。我们提出了一项严格的随机对照试验，由加州大学弗朗西斯科分校（UCSF）协调，有两个临床站点，UCSF和UC圣地亚哥，以确定恢复性瑜伽与拉伸对照组是否改善内脏肥胖，胰岛素敏感性，葡萄糖耐量，血脂异常和高血压142名活动不足的代谢综合征成年人。参与者将在每个研究中心随机分为两波，每组36名参与者，进行为期48周的试验。瑜伽组和对照组的参与者将在前6周每周参加两次集体课程，在第7-12周每周一次，在第13-24周每月两次。在6个月的评估后，两组将进入24周的维持期，并进行12个月的试验结束评估。我们提出以下具体目标：目的1：验证恢复性瑜伽减少内脏肥胖的假设（主要结局）并改善代谢综合征的特征：胰岛素抵抗、高血压、葡萄糖耐受不良和血脂异常（次要结局）与拉伸对照组相比，在24周干预后和额外的24周维持期后;目标2：测试与拉伸对照组相比，恢复性瑜伽减少压力（导致内脏肥胖和代谢综合征改善的潜在途径）的假设;目的3：测试减少内脏肥胖改善炎症因子和脂肪细胞因子的假设，这是改善代谢综合征的潜在机制。 公共卫生相关性：患有代谢综合征的人患2型糖尿病和心血管疾病的风险很高。我们提出了一项恢复性瑜伽的随机对照试验，这是一种放松形式的瑜伽，可以减少患有代谢综合征的成年人的代谢危险因素。如果瑜伽与改善代谢风险因素有关，这将提供一种廉价而安全的饮食和运动替代品，以延迟或预防糖尿病或心血管疾病。

DESCRIPTION (provided by applicant): Metabolic abnormalities, including visceral adiposity, insulin resistance, hyperglycemia, hypertension, and dyslipidemia, occur together and are associated with excess caloric intake and inadequate physical activity. Approximately 66% of American adults are overweight, and almost half of all obese persons meet criteria for the 'metabolic syndrome', which substantially increases risk of developing diabetes and cardiovascular disease. Lifestyle and behavioral interventions reduce these risks, but many individuals with increased metabolic risk find it difficult to achieve and maintain weight loss and increased physical activity. Yoga is an ancient self-awareness system that combines the use of body postures, breathing, and mental focus. A recent review of the effect of yoga on cardiovascular risk factors found beneficial changes in metabolic risk factors. We have completed two pilot trials of Restorative yoga, a type of yoga that uses supported poses to induce a state of total relaxation without muscular strain. In a randomized controlled pilot trial of overweight and underactive individuals with the metabolic syndrome, we found that teaching Restorative yoga to persons with the metabolic syndrome is feasible, and adherence and retention were excellent. After 10 weeks of weekly yoga training, there were trends toward improvements in weight, waist circumference, and blood pressure in the yoga group compared to the wait-list control group. We propose a rigorous randomized controlled trial coordinated by the University of California, San Francisco (UCSF) with two clinical sites, UCSF and UC San Diego, to determine whether Restorative yoga vs. a stretching control group improves visceral adiposity, insulin sensitivity, glucose tolerance, dyslipidemia, and hypertension among 142 underactive adults with the metabolic syndrome. Participants will be randomized in two waves of 36 participants at each site for a 48-week trial. Participants in the yoga and control groups will participate in group classes twice per week for the first 6 weeks, once per week during weeks 7-12, and twice per month during weeks 13-24. After evaluation at 6 months, both groups will enter a 24-week maintenance phase and undergo a 12-month end-of-trial evaluation. We propose the following specific aims: Aim 1: To test the hypotheses that Restorative yoga decreases visceral adiposity (primary outcome) and improves features of the metabolic syndrome: insulin resistance, hypertension, glucose intolerance, and dyslipidemia (secondary outcomes) compared to a stretching control group after a 24-week intervention and after an additional 24-week maintenance period; Aim 2: To test the hypotheses that Restorative yoga reduces stress (the potential pathway resulting in improved visceral adiposity and the metabolic syndrome) compared to the stretching control group; and Aim 3: To test the hypotheses that reduced visceral adiposity improves inflammatory factors and an adipocytokine, a potential mechanism for the amelioration of the metabolic syndrome. PUBLIC HEALTH RELEVANCE: Persons with the metabolic syndrome are at high risk of developing type 2 diabetes and cardiovascular disease. We propose a randomized, controlled trial of Restorative yoga, a relaxing form of yoga to reduce metabolic risk factors in adults with the metabolic syndrome. If yoga is associated with improved metabolic risk factors, this would offer an inexpensive and safe alternative to diet and exercise to delay or prevent diabetes or cardiovascular disease.