MSI-FLASH: An Exercise Intervention for Women with Menopausal Symptoms

描述（由申请人提供）：本提案与MSI-FLASH网络（月经症状倡议-寻找出汗和潮热的激光答案）一起提交，将比较两种不同剂量的运动与常规护理（更年期教育）缓解血管痉挛症状的疗效。两个运动组的目标运动消耗均为16 kcal/ kg/ wk，低剂量组的运动消耗为预测最大心率（HRmax）的50- 55%，高剂量组的运动消耗为HRmax的65-70%。运动试验的参与者将来自参与MSI-FLASH的4个现场：北方加州的Kaiser Permanente、西雅图的Group Health、宾夕法尼亚大学和印第安纳州大学。两个运动组的参与者将在干预开始时与运动顾问会面一次，然后在前两个月每周通过电话，在最后两个月每隔一周通过电话。咨询将强调与社会认知理论相一致的行为改变策略，例如设定中间小步目标，以及安全有效的运动训练所需的实用知识和技能。对照组每月接受书面健康教育材料和电话咨询。招募期将持续9个月，在此期间，将使用研究中心、人种/种族和绝经状态区组设计，随机分配450名符合合格标准的女性，每组人数大致相等。由于干预的性质，治疗分配将不设盲。将在干预开始、中间点和结束时评估VMS的频率（主观和客观测量）。其他共享网络结果，包括VMS的困扰，严重程度和干扰，情绪，睡眠和生活质量，也将在干预前后进行评估，以及重要的方案特定变量，如体力活动，身体健康和体型。MSI-FLASH的总体目标是通过创建一个由对更年期过渡有丰富知识且在开展女性健康方面经验丰富的科学家组成的网络，加速确定缓解血管舒缩症状的有效疗法，这是RFA-AG-08-004的主要目标。试验。MSI-FLASH数据协调中心（DCC）将由Andrea LaCroix和Garnet安德森共同领导，他们曾共同担任妇女健康倡议临床协调中心（西雅图）的联合主要研究员十多年。参与MSI-FLASH网络的5个临床现场研究中心位于波士顿（Lee Cohen和Hadine Joffe博士，PI）、印第安纳波利斯（Janet Carpenter博士，PI）、加利福尼亚州奥克兰（Barbara Sternfeld和Bette Caan博士，PI）、费城（Ellen Freeman博士，PI）和华盛顿州西雅图（凯瑟琳牛顿和Susan Reed博士，PI）。这个多学科的研究小组提出了五项随机对照试验，测试一系列的行为，身心，激素和药物干预。

DESCRIPTION (provided by applicant): This proposal, submitted in conjunction with the MSI-FLASH network (Menopausal Symptoms Initiative- Finding Lasing Answers to Sweats and Hot Flashes), will compare the efficacy of two different doses of exercise against usual care (menopause education) for alleviating vasomotor symptoms. Both exercise arms will have a target exercise expenditure of 16 kcal/ kg/ wk, with the lower dose group performing at 50- 55% of predicted maximum heart rate (HRmax), and the higher dose group performing at 65-70% HRmax. The participants in the exercise trial will be drawn from 4 of the field sites participating in MSI-FLASH: Kaiser Permanente Northern California, Group Health in Seattle, University of Pennsylvania, and University of Indiana. The participants in the two exercise groups will meet once in-person with an exercise counselor at the start of the intervention and then by phone every week for the first two months and every other week for the last two months. The counseling will emphasize behavioral change strategies consistent with social cognitive theory, such as the setting of intermediate small-step goals, as well as practical knowledge and skills necessary for safe and effective exercise training. The control group will receive written health education material and counseling monthly by telephone. The recruitment period will extend over nine months, during which 450 women, who meet eligibility criteria, will be randomly assigned, in approximately equal numbers to each arm, using a design blocked on site, race/ethnicity and menopausal status. Because of the nature of the intervention, treatment assignments will not be blinded. Frequency of VMS, measured both subjectively and objectively will be assessed at the beginning, mid-point, and end of the intervention. Other shared network outcomes, including bother, severity, and interference of VMS, mood, sleep, and quality of life, will also be assessed before and after the intervention, as will important protocol-specific variables, such as physical activity, physical fitness, and body size. The overall goal of MSI-FLASH is to accelerate the identification of effective remedies to relieve vasomotor symptoms, the main objective of RFA-AG-08-004, by creating a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials. The MSI-FLASH Data Coordinating Center (DCC) will be jointly led by Andrea LaCroix and Garnet Anderson who have served together as Co-Prinicpal Investigators of the Women's Health Initiative, Clinical Coordinating Center (Seattle) for more than a decade. The five clinical field sites participating in the MSI-FLASH network are located in Boston (Drs. Lee Cohen and Hadine Joffe, PIs),Indianapolis, IN (Dr. Janet Carpenter, PI),Oakland, CA (Drs. Barbara Sternfeld and Bette Caan, PIs), Philadelphia, PN (Dr. Ellen Freeman, PI) and Seattle, WA (Drs. Katherine Newton and Susan Reed, PIs). This multidisciplinary investigator group is proposing five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions.