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：
7682060
负责人：
BARBARA STERNFELD
金额：
$ 30.75万
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/7682060
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 Caucasians Caucasoid Race Clinical Cognitive Commit Control Groups Counseling Data Coordinating Center Dementia Dose Education Eligibility Determination 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 Menopause Menstruation Monitor Moods Nature Night Sweating 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 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 Weight Woman Women&apos s Health Writing Yoga alternative treatment base behavior change body-mind chemotherapy comparative efficacy design disorder later incidence prevention effective therapy experience fitness hormone therapy innovation malignant breast neoplasm meetings member middle age multidisciplinary response sedentary skills social social cognitive theory symposium treatment as usual

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 Network结合（绝经症状启动 - 寻找汗水和潮热的激光答案），将比较两种不同剂量的运动对常规护理（更年期教育）减轻血管运动症状的疗效。两个运动臂的目标运动支出为16 kcal/ kg/ wk，较低剂量组的表现为预测最大心率（HRMAX）的50-55％，而较高剂量组则以65-70％的hrmax进行。参加运动试验的参与者将从参加MSI-Flash的4个现场：Kaiser Permanente North California，Seattle，西雅图，宾夕法尼亚大学的集团健康和印第安纳大学。两个锻炼小组的参与者将在干预开始时与一名运动辅导员面对面见面，然后在过去两个月的前两个月通过电话通过电话。咨询将强调与社会认知理论一致的行为改变策略，例如中间小步骤目标的设定，以及安全有效的运动培训所需的实践知识和技能。对照组将每月通过电话获得书面健康教育材料和咨询。招聘期限将延长9个月，在此期间，符合资格标准的450名妇女将使用现场，种族/种族和绝经状态的设计，以大约相等的数量与每个手臂分配。由于干预的性质，治疗任务不会蒙蔽。 VM的频率，主观和客观地测量的频率将在干预的开始，中点和结尾进行评估。在干预之前和之后，还将评估其他共享的网络结果，包括困扰，严重程度和干扰，情绪，睡眠和生活质量，以及重要的特定于方案特定的变量，例如体育活动，身体健康和身体大小。 MSI-Flash的总体目标是加快鉴定有效补救措施以缓解血管舒缩症状，这是RFA-AG-08-004的主要目标，是通过建立一个科学家网络的网络，这些科学家网络对更年期过渡并在妇女健康试验的行为方面具有丰富的知识。 MSI-Flash数据协调中心（DCC）将由Andrea Lacroix和Garnet Anderson共同领导，他们曾担任妇女健康计划，临床协调中心（西雅图）的共同计划，已有十多年了。参与MSI-Flash网络的五个临床场地位于波士顿（李·科恩（Lee Cohen Cohen和Hadine Joffe博士），PIS，PIS），印第安纳波利斯，位于加利福尼亚州奥克兰（Janet Carpenter，pi）（珍妮特·卡彭特（Janet Carpenter），PI）（博士）和苏珊·里德（Susan Reed），pis）。这个多学科研究者组提出了五项随机对照试验，测试一系列行为，思维，荷尔蒙和药理干预措施。