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

描述(申请人提供)：这项提案与MSI-FLASH网络(更年期症状倡议-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)在缓解血管舒缩症状方面的效果。两个运动组的目标运动费用都是16千卡/公斤/周，其中低剂量组的运动速度是预测最大心率(HRmax)的50%-55%，高剂量组的运动速度是预测最大心率(HRmax)的65%-70%。演习试验的参与者将从参加MSI-FLASH的4个现场地点中挑选出来：加利福尼亚州北部的Kaiser Permanente，西雅图的Group Health，宾夕法尼亚大学和印第安纳大学。两个运动组的参与者将在干预开始时与运动顾问面对面会面一次，然后在前两个月每周通过电话，在最后两个月每隔一周见面。咨询将强调符合社会认知理论的行为改变策略，如设定中间的小步目标，以及安全有效的运动训练所需的实践知识和技能。对照组每月通过电话接受书面健康教育材料和咨询。招募期将超过9个月，在此期间，450名符合资格标准的妇女将被随机分配到每支队伍中，人数大致相同，采用现场受阻、种族/族裔和更年期状态的设计。由于干预的性质，治疗任务不会被盲目分配。主观和客观测量的VMS频率将在干预开始、中期和结束时进行评估。其他共享的网络结果，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，以及重要的协议特定变量，如身体活动、身体健康和体型。MSI-Flash的总体目标是通过建立一个对更年期过渡有高度了解并在妇女健康试验方面有经验的科学家网络，加快确定缓解血管舒缩症状的有效药物，这是RFA-AG-08-004的主要目标。MSI-Flash数据协调中心(DCC)将由Andrea LaCroix和Garnet Anderson共同领导，他们共同担任妇女健康倡议临床协调中心(西雅图)的联合Printicpal调查员已有十多年。参加MSI-FLASH网络的五个临床现场站点分别位于波士顿(Lee Cohen博士和Hadine Joffe博士，PI)、印第安纳波利斯、印第安纳波利斯(Janet Carpenter博士，PI)、加利福尼亚州奥克兰(Barbara Sternfeld博士和Bette Caan博士，PI)、费城PN(Ellen Freeman博士，PI)和西雅图(凯瑟琳·牛顿和苏珊·里德博士，PI)。这个多学科研究小组提出了五项随机对照试验，测试一系列行为、精神-身体、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.