Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

描述(由申请人提供)：R21 AT004234-01“综合瑜伽对客观和主观更年期潮热的有效性”的竞争性修订是对NOT-OD-09-058的回应：美国国立卫生研究院宣布恢复法资金可用于竞争性修订申请。资助R21试点基金的主要目标是获得有关积分瑜伽减少更年期潮热的疗效的初步数据。次要目标是确定瑜伽对客观潮热和其他结果的影响，并研究其可行性。我们的主要假设是，与两个对照组相比，瑜伽组的主观潮热频率和严重程度的下降幅度更大。次要结果包括客观潮热频率的更大减少；热潮热干扰的更大减少；瑜伽组在睡眠、其他症状、情绪和总体生活质量方面的更大改善。共有60名围绝经期或新近绝经后的女性每天至少出现7次潮热，并被随机分配到每周一次的瑜伽课程中，为期10周，作为教育对照组，或等待名单对照组。在此期间，所有女性都将监测她们的主观潮热。女性将在试验期开始、中期和结束时佩戴为期3天的动态潮热监测仪。在这一竞争性修订中，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，并帮助为瑜伽(也许还有其他身心)研究确定合适的控制组。通过下丘脑-垂体-肾上腺(HPA)轴介导的交感兴奋被认为是压力增加、焦虑和血管舒缩症状增加的机制。在这次修订中，我们建议增加心率变异性(HRV)和皮质醇的测量，作为瑜伽对潮热影响的潜在生理中介。这些额外的数据还将增加我们对拟议的教育控制组与瑜伽组的不同之处的了解。心率变异性和唾液皮质醇将在基线、治疗中期(5周)和治疗结束(10周)进行评估。HRV将在诊所收集，而皮质醇将在家中收集。对于每一次皮质醇采集，女性将在两天的4个预定时间点(醒来时、中午12点、下午5点和晚上10点)采取措施。干预后2个月将进行随访，但不涉及任何生理数据收集。等待名单上的女性将在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。这一竞争性修订将加快与了解瑜伽生理效应相关的科学研究的节奏，并将创造就业机会和留住就业机会。 与公共卫生相关：对许多女性来说，潮热和/或盗汗可能是与更年期有关的令人担忧的症状。目前治疗潮热的唯一有效方法是激素疗法，由于潜在的风险和副作用，许多女性不愿接受这种疗法。这个项目旨在确定瑜伽是否可以有效地减少潮热的频率和/或严重程度。

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.