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

MSI-FLASH：针对有更年期症状的女性的运动干预

基本信息

批准号：
7534207
负责人：
BARBARA STERNFELD
金额：
$ 30.82万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-15 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7534207
关键词：
African American Aging Alternative Medicine Asians Behavior Therapy Behavioral Bilateral oophorectomy Blinded Body Size Body Weight decreased Boston California Cancer Survivor Cardiovascular system Caring Caucasians Caucasoid Race Clinical Cognitive Commit Control Groups Counseling Data Coordinating Center Dementia Dose Education Eligibility Determination End Point Energy Metabolism Enrollment Estrogens Ethnic Origin Event Exercise Expenditure Fred Hutchinson Cancer Research Center Frequencies Goals Health Health education Hispanics Hormonal Hormonal Change Hot flushes Hysterectomy Indiana Innovative Therapy Institutes Intervention Intervention Studies Knowledge Living Wills Maximum Heart Rate Measures Menopausal Status Menopausal Symptom Menopausal hot flushes Menopause Menstruation Monitor Moods Nature Night Sweating Numbers Outcome Participant Patient Self-Report Pattern Pennsylvania Persons Pharmacologic Substance Philadelphia Physical Fitness Physical activity Placebos Population Postmenopause Prevalence Professional counselor Protocols documentation Publishing Quality of life Race Randomized Randomized Controlled Clinical Trials Randomized Controlled Trials Range Recruitment Activity Relative (related person)Reporting Request for Applications Research Research Personnel Respiration Rewards Risk Science Scientist Series Severities Site Sleep Stimulus Sweat Sweating Symptoms Telephone Testing Training United States Universities Upper arm Vasomotor Washington Week Weight Woman Women&apos s Health Writing Yoga base behavior change body-mind chemotherapy day design disorder later incidence prevention experience fitness hormone therapy innovation malignant breast neoplasm member middle age multidisciplinary response sedentary size skills social social cognitive theory symposium

项目摘要

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.

描述（由申请人提供）：该提案与 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）的效果）用于缓解血管舒缩症状。两个运动臂的目标运动消耗均为 16 kcal/kg/周，较低剂量组的运动强度为预计最大心率 (HRmax) 的 50-55%，较高剂量组的运动强度为预测最大心率 (HRmax) 的 65-70%。演习试验的参与者将从参与 MSI-FLASH 的 4 个现场站点中抽取：北加州 Kaiser Permanente、西雅图 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一次和最后两个月每隔一周通过电话一次。咨询将强调符合社会认知理论的行为改变策略，例如设定中间小步骤目标，以及安全有效的运动训练所需的实用知识和技能。对照组将每月收到书面健康教育材料和电话咨询。招募期将持续九个月以上，在此期间，450 名符合资格标准的女性将被随机分配到每组，人数大致相等，采用现场设计、种族/民族和更年期状况。由于干预的性质，治疗分配不会采用盲法。将在干预的开始、中点和结束时评估主观和客观测量的 VMS 频率。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，以及重要的协议特定变量，例如体力活动、身体健康、和车身尺寸。 MSI-FLASH 的总体目标是通过建立一个对更年期过渡有深入了解并在更年期过渡方面经验丰富的科学家网络，加速确定缓解血管舒缩症状的有效疗法，这也是 RFA-AG-08-004 的主要目标。进行妇女健康试验。 MSI-FLASH 数据协调中心 (DCC) 将由 Andrea LaCroix 和 Garnet Anderson 共同领导，他们十多年来一直担任临床协调中心（西雅图）妇女健康倡议的联合首席研究员。参与 MSI-FLASH 网络的五个临床现场站点位于波士顿（Lee Cohen 博士和 Hadine Joffe 博士，PI）、印第安纳州印第安纳波利斯（Janet Carpenter 博士，PI）、加利福尼亚州奥克兰（Barbara Sternfeld 博士和 Bette） Caan，PI）、费城，PN（Ellen Freeman 博士，PI）和西雅图，华盛顿州（Katherine Newton 和 Susan 博士）里德，PI）。这个多学科研究小组正在提出五项随机对照试验，测试一系列行为、身心、激素和药物干预措施。