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Women's Health Initiative Strong and Healthy Study (WHISH)

Primary Purpose

Myocardial Infarction, Stroke, Cardiovascular Mortality

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Physical Activity, National Institute of Aging Go4Life, Postmenopausal Women, Balance, Strength, Exercise, Cardiovascular Disease, Stroke, Mortality, Myocardial Infarction, Falls, Venous Thromboembolic Event, Peripheral Artery Disease, Physical Function, Mobility and Independence, Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Intervention (PCI), Hip Fractures, Cardiovascular Mortality, Clinical (non-hip) Fractures, Sleep, Depressive Symptoms

Eligibility Criteria

66 Years - 99 Years (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Currently enrolled in the Women's Health Initiative (WHI) Extension Study
  • Known to be alive
  • Cardiovascular outcomes will be available (enrolled in the WHI Medical Records Cohort or linked to Medicare Data)

Exclusion Criteria:

  • Inability to walk
  • Dementia
  • Residing in a nursing home

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Physical Activity Intervention

    Usual Activity Control

    Arm Description

    The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults

    Usual activity

    Outcomes

    Primary Outcome Measures

    Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
    Adjudicated events
    Non-Cardiovascular Disease Mortality
    Safety; adjudicated event
    Hip Fracture
    Safety; adjudicated event
    Clinical (non-hip) Fracture
    Safety
    Falls
    Safety; self-report

    Secondary Outcome Measures

    Venous Thromboembolic Event
    Adjudicated event
    Peripheral Artery Disease
    Adjudicated event
    Physical Function (Physical Function Score from self-report)
    Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
    Mobility and Independence (Physical Function Score from self-report)
    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.
    Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
    Safety; adjudicated events
    Short Physical Performance Battery (SPPB)
    Short Performance Battery (SPPB). Scoring uses the Look AHEAD methods that were based on Health ABC (Simonsick EM, Newman AB, Nevitt MC, et al. Measuring higher level physical function in well-functioning older adults: expanding familiar approaches in the Health ABC Study. J Gerontol Med Sci. 2001;56A,M644-M649.) The SPPB score is sum of three ratios, the Standing Balance Ratio (SBRatio), the Chair Stand Ratio (CSRatio), and the Usual Walk Ratio (UWRatio). The results are in a continuous score ranging from 0 to 3. s (balance, gait speed, stair stand) are each scored 0 or 1 with the three scores summed for an SPPB score of 0 to 3 from lowest to highest physical function. Implemented in a subset.
    Sleep Disturbance
    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.
    Depressive Symptoms
    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.

    Full Information

    First Posted
    April 16, 2015
    Last Updated
    September 22, 2023
    Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    University of California, San Diego, Stanford University, National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02425345
    Brief Title
    Women's Health Initiative Strong and Healthy Study
    Acronym
    WHISH
    Official Title
    Women's Health Initiative Strong and Healthy Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    April 2, 2015 (Actual)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    University of California, San Diego, Stanford University, National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The WHISH trial applies state-of-the science behavioral principles and currently available technologies to deliver a physical activity intervention without face-to-face contact to ~25,000 older U.S. women expected to consent. It includes the National Institute of Aging (NIA) Go4Life® Exercise & Physical Activity materials 3 and WHISH developed targeted materials based on Go4Life® to provide inspirational tips and recommendations about how to achieve nationally recommended levels of PA and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. The intervention builds upon evidence-based behavioral science principles and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive approaches to tailoring the delivery to meet individual (personal) needs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction, Stroke, Cardiovascular Mortality, Hip Fractures, Falls, Mortality, Venous Thromboembolic Event, Peripheral Artery Disease, Physical Function, Coronary Revascularization, Mobility and Independence, Clinical (Non-hip) Fractures, Sleep, Depressive Symptoms
    Keywords
    Physical Activity, National Institute of Aging Go4Life, Postmenopausal Women, Balance, Strength, Exercise, Cardiovascular Disease, Stroke, Mortality, Myocardial Infarction, Falls, Venous Thromboembolic Event, Peripheral Artery Disease, Physical Function, Mobility and Independence, Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Intervention (PCI), Hip Fractures, Cardiovascular Mortality, Clinical (non-hip) Fractures, Sleep, Depressive Symptoms

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    49331 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Activity Intervention
    Arm Type
    Experimental
    Arm Description
    The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults
    Arm Title
    Usual Activity Control
    Arm Type
    No Intervention
    Arm Description
    Usual activity
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Activity
    Intervention Description
    The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
    Primary Outcome Measure Information:
    Title
    Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
    Description
    Adjudicated events
    Time Frame
    9 years
    Title
    Non-Cardiovascular Disease Mortality
    Description
    Safety; adjudicated event
    Time Frame
    9 years
    Title
    Hip Fracture
    Description
    Safety; adjudicated event
    Time Frame
    9 years
    Title
    Clinical (non-hip) Fracture
    Description
    Safety
    Time Frame
    9 years
    Title
    Falls
    Description
    Safety; self-report
    Time Frame
    9 years
    Secondary Outcome Measure Information:
    Title
    Venous Thromboembolic Event
    Description
    Adjudicated event
    Time Frame
    9 years
    Title
    Peripheral Artery Disease
    Description
    Adjudicated event
    Time Frame
    9 years
    Title
    Physical Function (Physical Function Score from self-report)
    Description
    Rand-36 Physical Function Scale. Score 0-100; a higher score indicates a more favorable health state in regards to physical functioning.
    Time Frame
    9 years
    Title
    Mobility and Independence (Physical Function Score from self-report)
    Description
    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.
    Time Frame
    9 years
    Title
    Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
    Description
    Safety; adjudicated events
    Time Frame
    9 years
    Title
    Short Physical Performance Battery (SPPB)
    Description
    Short Performance Battery (SPPB). Scoring uses the Look AHEAD methods that were based on Health ABC (Simonsick EM, Newman AB, Nevitt MC, et al. Measuring higher level physical function in well-functioning older adults: expanding familiar approaches in the Health ABC Study. J Gerontol Med Sci. 2001;56A,M644-M649.) The SPPB score is sum of three ratios, the Standing Balance Ratio (SBRatio), the Chair Stand Ratio (CSRatio), and the Usual Walk Ratio (UWRatio). The results are in a continuous score ranging from 0 to 3. s (balance, gait speed, stair stand) are each scored 0 or 1 with the three scores summed for an SPPB score of 0 to 3 from lowest to highest physical function. Implemented in a subset.
    Time Frame
    4 years
    Title
    Sleep Disturbance
    Description
    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.
    Time Frame
    4 years
    Title
    Depressive Symptoms
    Description
    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.
    Time Frame
    4 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    66 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Currently enrolled in the Women's Health Initiative (WHI) Extension Study Known to be alive Cardiovascular outcomes will be available (enrolled in the WHI Medical Records Cohort or linked to Medicare Data) Exclusion Criteria: Inability to walk Dementia Residing in a nursing home
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles L Kooperberg, PhD
    Organizational Affiliation
    Fred Hutchinson Cancer Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Andrea Z LaCroix, PhD
    Organizational Affiliation
    University of California, San Diego
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marcia L Stefanick, PhD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33433559
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35691486
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/33433559/
    Description
    Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics

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