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临床试验/NCT03099889
NCT03099889Unknown不适用

Women's Health Initiative Strong and Healthy Exercise Trial-2-Prevent Heart Failure

Memorial Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 49,936 人开始时间: 2015年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
49,936
试验地点
2
主要终点
hospitalized heart failure

研究概览

简要总结

The WHISH-2-Prevent Heart Failure (HF) study is an ancillary study to the Women's Health Initiative Strong and Healthy (WHISH) exercise pragmatic trial. The WHISH-2-Prevent HF trial examines the intervention effect of physical activity (PA) on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF. The focus of the parent WHISH trial is on atherosclerotic cardiovascular disease and not heart failure.

详细描述

A recently funded large pragmatic PA trial, Women's Health Initiative Strong and Healthy (WHISH) trial based upon two decades of PA intervention experience using enhanced communication and behavioral techniques, has randomized 49,936 elderly women (average age 79) and will evaluate its intervention effect on the risk of atherosclerotic CVD. This translational intervention is aimed at reducing sedentary time and achieving or maintaining aerobic and strength enhancing PA levels currently recommended for cardiovascular benefit. The WHISH-2-Prevent HF, represents the first and largest primary prevention exercise trial ever performed focusing on HF and will examine the intervention effect of PA , on both incident HF and HF burden (recurrent HF and CVD death in those with HF) in a cost effective manner in elderly women. In addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of PA that leads to a reduced risk and burden of HF.

Aim 1: Test whether older women who are initially free of HF and randomized to a translational PA intervention will reduce the rate of incident HF compared to those not randomized to the translational PA intervention.

H1: Women free of HF randomized to the PA intervention will have reduced rates of incident HF compared to those not randomized.

Aim 2: Test whether older women with and without HF at baseline randomized to a translational PA intervention will reduce the HF burden (number of acute HF hospitalizations and CVD death in those with antecedent HF) compared to those not randomized to the translational PA intervention. H2: Women randomized to the PA intervention will have reduced HF Burden compared to those not randomized

Exploratory Aim 3: Analyze the type, intensity and frequency of physical activity including skeletal muscle strengthening associated with a reduced risk of HF and HF burden in elderly women. H3: Women who have low levels of sedentary behavior by either increasing or maintaining light intensity or moderate intensity physical activity will have reduced rates of HF compared to women who remain sedentary. Those that add skeletal muscle strengthening will have additional benefits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participant in intervention arm signed an informed consent umasking the exercise intervention, participants in the control arm have already consented to ongoing outcomes assessment and yearly surveys regarding physical activity and other lifestyle activities

入排标准

年龄范围
66 Years 至 102 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • alive, community dwelling,

排除标准

  • Dementia, need walking aide, reside in nursing home

研究组 & 干预措施

Physical Activity intervention arm

Experimental

Receive a tailored behavioral interventions for exercise and strength training via multiple channels including frequent mailings, integrated voice response and outreach phone calls, interactive website, and referral to local community exercise resources.

干预措施: Physical Activity (Behavioral)

Control arm

No Intervention

Receive general health mailings

结局指标

主要结局

hospitalized heart failure

时间窗: within 4 years of randomization

first acute decompensated hospitalized heart failure event

次要结局

  • Recurrent hospitalized heart failure(within 4 years of randomization)
  • Cardiovascular disease mortality(within 4 years of randomization)
  • Heart failure with preserved ejection fraction(within 4 years of randomization)
  • Heart failure with reduced ejection fraction(within 4 years of randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles B. Eaton

Principal Investigator

Memorial Hospital of Rhode Island

研究点 (2)

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