妇女健康倡议强壮健康研究 (WHISH)
2026年7月6日 更新者:Fred Hutchinson Cancer Center
WHISH 试验应用最先进的科学行为原理和当前可用的技术,为约 25,000 名预计同意的美国老年妇女提供无需面对面接触的身体活动干预。
它包括国家老龄化研究所 (NIA) Go4Life® 运动和身体活动材料 3 以及 WHISH 基于 Go4Life® 开发的针对性材料,以提供关于如何达到国家推荐的 PA 水平和克服运动障碍的鼓舞人心的技巧和建议,以及自我监控和设定个人目标的手段。
该干预措施建立在循证行为科学原则和干预措施的基础上,这些原则和干预措施已被证明可有效增加老年妇女的体力活动,并采用创新的适应性方法来定制分娩以满足个人(个人)需求。
研究概览
地位
完全的
干预/治疗
研究类型
介入性
注册 (实际的)
49331
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
66年 至 99年 (年长者)
接受健康志愿者
是的
描述
纳入标准:
- 目前正在参加妇女健康倡议 (WHI) 扩展研究
- 已知还活着
- 心血管结果将可用(在 WHI 医疗记录队列中注册或链接到 Medicare 数据)
排除标准:
- 无法行走
- 失智
- 住在疗养院
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:身体活动干预
身体活动干预小组将接受有关身体活动的指导,包括有氧运动、灵活性、平衡、力量和减少久坐时间。
主要资源是国家老年研究所 Go4Life 运动和身体活动材料。
这些材料基于美国国家老年人体育活动指南
|
PA 干预将包括有氧运动、平衡、力量和灵活性的多模式活动计划。
干预将包括鼓励参与者全天增加各种形式的体力活动,并减少久坐时间,例如坐着。
这可能包括休闲运动、园艺、使用楼梯代替自动扶梯、与朋友悠闲散步以及减少使用遥控设备等活动。干预主要通过邮件进行,并提供网站支持和可用资源。
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无干预:日常活动控制
平时活动
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
大体时间:median 8.7 years
|
WHI centrally adjudicated events and CMS FFS-identified events.
CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.
|
median 8.7 years
|
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Physical Function (Physical Function Score From Self-report, RAND-36)
大体时间:Annually each year of the 9 years of the trial. The single value for this Outcome is based on the average of all collected measurements.
|
Rand-36 Physical Function Scale.
Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
The single value for this Outcome is based on the average of all collected measurements.
|
Annually each year of the 9 years of the trial. The single value for this Outcome is based on the average of all collected measurements.
|
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Non-Cardiovascular Disease Mortality
大体时间:median 8.7 years
|
Safety.
WHI centrally adjudicated events and CMS FFS-identified events.
|
median 8.7 years
|
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Hip Fracture
大体时间:median 8.7 years
|
Safety.
WHI centrally adjudicated events and CMS FFS-identified events.
|
median 8.7 years
|
|
Falls / Year
大体时间:median 8.7 years
|
Safety; self-report
|
median 8.7 years
|
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Clinical (Non-hip) Fracture
大体时间:median 8.7 years
|
Safety. Self-report
|
median 8.7 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peripheral Artery Disease
大体时间:median 8.7 years
|
WHI centrally adjudicated events and CMS FFS-identified events.
|
median 8.7 years
|
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Venous Thromboembolic Event
大体时间:median 8.7 years
|
WHI centrally adjudicated events and CMS FFS-identified events.
|
median 8.7 years
|
|
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
大体时间:median 8.7 years
|
Safety; adjudicated events
|
median 8.7 years
|
|
Mobility Loss
大体时间:median 8.7 years
|
Self-report of ability to climb one flight of stairs or ability to walk one block. Scored 1, 2 or 3 with 1=limited a lot, 2=limited a little, 3=not limited at all. Either stairs or walk with score of 2 or 3 is defined as being able to be mobile. Mobility Loss: Defined as Yes if a participant self-reports being limited a lot (score =1) in both climbing one flight of stairs and walking one block. Mobility loss defined as Yes is reported as an Event. |
median 8.7 years
|
|
Short Physical Performance Battery (SPPB)
大体时间:One time per participant analyzed during study year 7, 8, or 9.
|
SPPB collected one time during second funding period for WHISH, within the 4-year trial period, as part of the Women's Health Initiative in-home visit, the Long Life Study 2 during 2022-2024.
The Established Populations for the Epidemiologic Studies of the Eldery (EPESE) Short Physical Performance Battery (SPPB) ranges from 0 to 12, with higher scores indicating better physical performance.
|
One time per participant analyzed during study year 7, 8, or 9.
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Sleep Disturbance
大体时间:Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.
|
Self-report of sleep patterns such as falling asleep, waking during the night, quality of night's sleep.
Score scale: 0 - 20; a higher score indicates greater sleep disturbance.
Levine DW, Kaplan RM, Kripke DF, Naughton MJ, Shumaker SA.
Factor structure and measurement invariance of the Women's Health Initiative Insomnia Rating Scale.
Psycho Assess.
2003 Jun; 15(2):123-36.
Data not collected prior to 1/6/2021.
The single value for this Outcome is based on the average of all collected measurements.
|
Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.
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Depressive Symptoms
大体时间:Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.
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Shortened version of the Center for Epidemiological Studies Depression Scale (CES- D).
Score (probability) for depression.
Score scale: 0 - 1; a higher score indicates a greater likelihood of depression.
Burman M, Wells K, Leake B, Landsverk J. Development of a brief screening instrument for detecting depressive disorders.
Medical care 1988; 26: 8, 775-789.
Data not collected prior to 1/6/2021.
The single value for this Outcome is based on the average of all collected measurements.
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Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Charles L Kooperberg, PhD、Fred Hutchinson Cancer Center
- 首席研究员:Marcia L Stefanick, PhD、Stanford University
- 首席研究员:Andrea Z LaCroix, PhD、University of California, San Diego
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Stefanick ML, King AC, Mackey S, Tinker LF, Hlatky MA, LaMonte MJ, Bellettiere J, Larson JC, Anderson G, Kooperberg CL, LaCroix AZ. Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):725-734. doi: 10.1093/gerona/glaa325.
- Stefanick ML, Kooperberg C, LaCroix AZ. Women's Health Initiative Strong and Healthy (WHISH): A pragmatic physical activity intervention trial for cardiovascular disease prevention. Contemp Clin Trials. 2022 Aug;119:106815. doi: 10.1016/j.cct.2022.106815. Epub 2022 Jun 9.
- Mendoza-Vasconez AS, King AC, Chandler G, Mackey S, Follis S, Stefanick ML. Engagement With Remote Delivery Channels in a Physical Activity Intervention for Senior Women in the US. Am J Health Promot. 2024 Jun;38(5):692-703. doi: 10.1177/08901171241229537. Epub 2024 Feb 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月2日
初级完成 (实际的)
2024年12月31日
研究完成 (实际的)
2024年12月31日
研究注册日期
首次提交
2015年4月16日
首先提交符合 QC 标准的
2015年4月23日
首次发布 (估计的)
2015年4月24日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 4R33HL151885-02 (美国 NIH 拨款/合同)
- 1U01HL122280-01A1 (美国 NIH 拨款/合同)
- 1U01HL122273-01A1 (美国 NIH 拨款/合同)
- RG1001184 (其他标识符:Fred Hutchinson Cancer Center)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.