WAKE FOREST UNIVERSITY
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.