Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

描述（由申请人提供）：R21 AT 004234 -01“整体瑜伽对客观和主观月经潮热的有效性”的竞争性修订版是对NOT-OD-09-058的回应：NIH宣布恢复法案资金可用于竞争性修订申请。 资助R21试点赠款的主要目标是获得关于整体瑜伽减少更年期潮热疗效的初步数据。次要目的是确定瑜伽对客观潮热和其他结果的影响以及研究的可行性。我们的主要假设是，瑜伽组的主观潮热频率和严重程度比两个对照组有更大的降低。次要结果包括客观潮热频率的更大减少;潮热干扰的更大减少;瑜伽组的睡眠，其他症状，情绪和整体生活质量的更大改善。 总共招募了60名每天至少经历7次潮热的绝经后妇女，并随机分配参加每周一次的瑜伽课程，为期10周，教育对照组或候补对照组。在此期间，所有女性都会监测自己的主观潮热。女性将在试验期开始、中间和结束时佩戴动态潮热监测仪3天。 在这个竞争性修订中，我们计划增加生理测量作为额外的结果，以帮助解释瑜伽有效性的机制，并帮助确定瑜伽（也许还有其他身心）研究的适当对照组。通过下丘脑-垂体-肾上腺（HPA）轴介导的交感神经兴奋已被理论认为是压力和焦虑增加以及血管扩张症状的机制。在这次修订中，我们建议增加心率变异性（HRV）和皮质醇的措施，作为瑜伽对潮热影响的潜在生理介质。这些额外的数据也将增加我们对拟议的教育对照组与瑜伽组之间差异的了解。将在基线、治疗中期（5周）和治疗结束（10周）时评估心率变异性和唾液皮质醇。HRV将在诊所环境中采集，而皮质醇将在家中采集。对于每次皮质醇收集，女性将在两天内的4个预定时间点（醒来时，中午12点，下午5点和晚上10点）进行测量。将在干预后2个月进行随访，但不涉及任何生理数据收集。等待名单中的女性将在10周后被随机分配参加瑜伽或教育课程，但在此期间不会收集额外的生理数据。 这种竞争性的修订将加快与了解瑜伽的生理作用有关的科学研究的克里思，也将允许创造和保留就业机会。 公共卫生相关性：对于许多女性来说，潮热和/或盗汗可能是与更年期相关的令人不安的症状。目前唯一有效的治疗潮热的方法是激素治疗，许多妇女不愿意采取，因为潜在的风险和不良副作用。该项目旨在确定瑜伽是否可以成为减少潮热频率和/或严重程度的有效方法。

DESCRIPTION (provided by applicant): This competitive revision of R21 AT004234-01 "Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes" is in response to NOT-OD-09-058: NIH Announces the Availability of Recovery Act Funds for Competitive Revision Applications. The primary goal of the funded R21 pilot grant is to obtain preliminary data on the efficacy of Integral Yoga for reducing menopausal hot flashes. Secondary aims are to determine the impact of yoga on objective hot flashes and other outcomes and study feasibility. Our primary hypothesis is a greater reduction in subjective hot flash frequency and severity in the yoga group than two control groups. Secondary outcomes include a greater reduction in objective hot flash frequency; a greater decrease in hot flash interference; greater improvement in sleep, other symptoms, mood, and overall quality of life in the yoga group. A total of 60 peri or newly postmenopausal women experiencing at least 7 hot flashes per day are being recruited and randomly assigned to participate in weekly yoga sessions for 10 weeks, an educational control group, or a waitlist control group. During this time, all women will monitor their subjective hot flashes. Women will wear an ambulatory hot flash monitor for 3 days at the beginning, middle, and end of the trial period. In this competitive revision, we plan to add physiological measures as additional outcomes to help explain the mechanisms of yoga's effectiveness and to help identify appropriate control groups for yoga (and perhaps other mind-body) research. Sympathetic arousal mediated through the hypothalamic-pituitary-adrenal (HPA) axis has been theorized as the mechanism of increased stress and anxiety and vasomotor symptoms. In this revision, we propose adding measures of heart rate variability (HRV) and cortisol as potential physiological mediators of the effect of yoga on hot flashes. These additional data will also add to our knowledge of how the proposed educational control group differs from the yoga group. Heart rate variability and salivary cortisol will be assessed at baseline, mid-treatment (5 weeks) and end of treatment (10 weeks). HRV will be collected in the clinic setting while cortisol will be collected at home. For each cortisol collection, women will take measures at 4 predetermined timepoints for two days (upon awakening, 12 noon, 5 PM, and 10 PM). A follow-up will be conducted 2 months post-intervention, but will not involve any physiological data collection. Waitlist women will be randomly assigned to participate in yoga or educational sessions after 10 weeks, but no additional physiological data will be collected during this time. This competitive revision will accelerate the tempo of scientific research related to understanding the physiological effects of yoga and will also allow for job creation and retention. PUBLIC HEALTH RELEVANCE: For many women, hot flashes and/or night sweats can be troubling symptoms associated with menopause. The only currently effective treatment for hot flashes is hormone therapy, which many women are reluctant to take because of potential risks and adverse side effects. This project seeks to determine if yoga can be an effective method to reduce the frequency and/or severity of hot flashes.