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CompletedNCT02425345WHISHUpdated Jul 31, 2026Results posted

Women's Health Initiative Strong and Healthy Study

An interventional study of Physical Activity in Myocardial Infarction, Stroke and Cardiovascular Mortality, sponsored by Fred Hutchinson Cancer Center. Completed. Open to female participants aged 66 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
49,331
Allocation
Randomized
Ages
66 Years to 99 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 49,331 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
66 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Inability to walk
  • Dementia
  • Residing in a nursing home
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
49,331 participants (actual)

Study arms

  • Experimental
    Physical Activity Intervention

    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

    Behavioral: Physical Activity

  • No intervention
    Usual Activity Control

    Usual activity

Interventions

  • BehavioralPhysical Activity

    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.

06

What researchers measure

Primary outcomes

  1. Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality

    WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.

    Time frame: median 8.7 years

  2. Physical Function (Physical Function Score From Self-report, RAND-36)

    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.

    Time frame: 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.

  3. Non-Cardiovascular Disease Mortality

    Safety. WHI centrally adjudicated events and CMS FFS-identified events.

    Time frame: median 8.7 years

  4. Hip Fracture

    Safety. WHI centrally adjudicated events and CMS FFS-identified events.

    Time frame: median 8.7 years

  5. Falls / Year

    Safety; self-report

    Time frame: median 8.7 years

  6. Clinical (Non-hip) Fracture

    Safety. Self-report

    Time frame: median 8.7 years

Secondary outcomes

  1. Peripheral Artery Disease

    WHI centrally adjudicated events and CMS FFS-identified events.

    Time frame: median 8.7 years

  2. Venous Thromboembolic Event

    WHI centrally adjudicated events and CMS FFS-identified events.

    Time frame: median 8.7 years

  3. Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)

    Safety; adjudicated events

    Time frame: median 8.7 years

  4. Mobility Loss

    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.

    Time frame: median 8.7 years

  5. Short Physical Performance Battery (SPPB)

    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.

    Time frame: One time per participant analyzed during study year 7, 8, or 9.

  6. 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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

    Time frame: Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.

  7. 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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

    Time frame: Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.

07

Results

Posted May 13, 2026

Participant flow

Participant flow — Overall Study
MilestonePhysical Activity InterventionUsual Activity Control
Started2465724674
Completed2465724674
Not completed00

Outcome measures

PrimaryCardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality

WHI centrally adjudicated events and CMS FFS-identified events. CVD defined as (first event since enrollment in WHISH of) MI, stroke, cardiovascular (CV) death.

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
ParticipantsPhysical Activity InterventionUsual Activity Control
Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality52315324
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.49 (Differences in clinical outcomes by outcome source were assessed by proportional hazards models with each outcome as a function of trial arm, stratified within the proportional hazards model by age strata, census region, and prevalent disease.) · Hazard ratio (hr): 0.99 · 95% CI 0.95 to 1.02
PrimaryPhysical Function (Physical Function Score From Self-report, RAND-36)

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.

Time frame:
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.
Reported as:
Mean · Score
Physical Function (Physical Function Score From Self-report, RAND-36)
ScorePhysical Activity InterventionUsual Activity Control
Physical Function (Physical Function Score From Self-report, RAND-36)59.73 ± 26.7658.73 ± 26.82
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Linear · p = <0.001 (Least squares mean difference, 95% CI, and p-value computed from a linear model adjusted for age, region, and study cohort. In this relatively simple model, Means and SD are acceptable reporting measures.) · Mean difference (final values): 0.91 · 95% CI 0.46 to 1.37
PrimaryNon-Cardiovascular Disease Mortality

Safety. WHI centrally adjudicated events and CMS FFS-identified events.

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Non-Cardiovascular Disease Mortality
ParticipantsPhysical Activity InterventionUsual Activity Control
Non-Cardiovascular Disease Mortality63366310
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.85 · Hazard ratio (hr): 1.00 · 95% CI 0.97 to 1.04
PrimaryHip Fracture

Safety. WHI centrally adjudicated events and CMS FFS-identified events.

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Hip Fracture
ParticipantsPhysical Activity InterventionUsual Activity Control
Hip Fracture18091813
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.96 · Hazard ratio (hr): 1.00 · 95% CI 0.94 to 1.07
PrimaryFalls / Year

Safety; self-report

Time frame:
median 8.7 years
Reported as:
Mean · Falls / year
Falls / Year
Falls / yearPhysical Activity InterventionUsual Activity Control
Falls / Year0.55 ± 0.590.57 ± 0.60
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Poisson regression model (footnote 5 PF) · p = 0.004 (Calculated from annual self-reported falls per year; ≥ 3 is counted as 3. Least squares mean difference, 95% CI, and p-value from a Poisson model adjusted for age, region, and study cohort.) · Mean difference (final values): -0.03 · 95% CI -0.06 to -0.01Least squares mean difference, 95% CI, and p-value computed from a linear model adjusted for age, region, and study cohort. In this relatively simple model, Means and SD are acceptable reporting measures.
SecondaryPeripheral Artery Disease

WHI centrally adjudicated events and CMS FFS-identified events.

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Peripheral Artery Disease
ParticipantsPhysical Activity InterventionUsual Activity Control
Peripheral Artery Disease217211
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.67 · Hazard ratio (hr): 1.04 · 95% CI 0.86 to 1.26
SecondaryVenous Thromboembolic Event

WHI centrally adjudicated events and CMS FFS-identified events.

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Venous Thromboembolic Event
ParticipantsPhysical Activity InterventionUsual Activity Control
Venous Thromboembolic Event14931520
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.58 · Hazard ratio (hr): 0.98 · 95% CI 0.91 to 1.05
SecondaryCoronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)

Safety; adjudicated events

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
ParticipantsPhysical Activity InterventionUsual Activity Control
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)867868
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.90 · Hazard ratio (hr): 0.99 · 95% CI 0.90 to 1.09
SecondaryMobility Loss

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.

Time frame:
median 8.7 years
Reported as:
Number · Events
Mobility Loss
EventsPhysical Activity InterventionUsual Activity Control
Mobility Loss53045631
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.15 · Hazard ratio (hr): 0.97 · 95% CI 0.94 to 1.01
SecondaryShort Physical Performance Battery (SPPB)

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.

Time frame:
One time per participant analyzed during study year 7, 8, or 9.
Reported as:
Mean · Score
Short Physical Performance Battery (SPPB)
ScorePhysical Activity InterventionUsual Activity Control
Short Physical Performance Battery (SPPB)7.38 ± 2.707.37 ± 2.71
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Linear · p = 0.86 · Mean difference (final values): 0.02 · 95% CI -0.15 to 0.18
SecondarySleep 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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

Time frame:
Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.
Reported as:
Mean · Score
Sleep Disturbance
ScorePhysical Activity InterventionUsual Activity Control
Sleep Disturbance8.26 ± 3.098.23 ± 3.11
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Linear · p = 0.42 (Sleep Disturbance Construct ranges from 0 to 20 with a higher score indicating greater sleep disturbance, not collected prior to 1/6/2021.) · Mean difference (final values): 0.03 · 95% CI -0.04 to 0.10Least squares mean difference, 95% CI, and p-value computed from a linear model adjusted for age, region, and study cohort. In this relatively simple model, Means and SD are acceptable reporting measures.
PrimaryClinical (Non-hip) Fracture

Safety. Self-report

Time frame:
median 8.7 years
Reported as:
Count of participants · Participants
Clinical (Non-hip) Fracture
ParticipantsPhysical Activity InterventionUsual Activity Control
Clinical (Non-hip) Fracture68567088
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Cox · p = 0.27 · Hazard ratio (hr): 0.98 · 95% CI 0.95 to 1.01
SecondaryDepressive 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. Data not collected prior to 1/6/2021. The single value for this Outcome is based on the average of all collected measurements.

Time frame:
Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.
Reported as:
Mean · Score
Depressive Symptoms
ScorePhysical Activity InterventionUsual Activity Control
Depressive Symptoms0.034 ± 0.1080.036 ± 0.109
Statistical analysis
  • Physical Activity Intervention vs Usual Activity Control · Regression, Linear · p = 0.33 (Shortened CES-D/DIS Screening Instrument ranges from 0 to 1 with a higher score indicating a greater likelihood of depression, not collected prior to 1/6/2021. (foot 6 PF)) · Mean difference (final values): -0.001 · 95% CI -0.004 to 0.001Least squares mean difference, 95% CI, and p-value computed from a linear model adjusted for age, region, and study cohort. (foot 1 PF)

Adverse events

Collected over median 8.7 years. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Physical Activity Intervention9,614/24,657 (39%)0/24,657 (0%)0/24,657 (0%)
Usual Activity Control9,697/24,674 (39.3%)0/24,674 (0%)0/24,674 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years of age)Physical Activity InterventionUsual Activity ControlTotal
Mean79.8 ± 6.279.7 ± 6.279.7 ± 6.2
Sex: Female, Male
Sex: Female, Male(Participants)Physical Activity InterventionUsual Activity ControlTotal
Female246572467449331
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Physical Activity InterventionUsual Activity ControlTotal
American Indian or Alaska Native4856104
Asian452423875
Native Hawaiian or Other Pacific Islander162238
Black or African American219021614351
White213982143942837
More than one race291311602
Unknown or Not Reported262262524
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Physical Activity InterventionUsual Activity ControlTotal
Hispanic or Latino9159001815
Not Hispanic or Latino237002372947429
Unknown or Not Reported424587
US Census Region
US Census Region(Participants)Physical Activity InterventionUsual Activity ControlTotal
Northeast6010604012050
South7063704514108
Midwest5737575111488
West5847583811685
Education
Education(Participants)Physical Activity InterventionUsual Activity ControlTotal
<= High school / GED424941268375
School after high school8730867717407
>= College degree115231174623269
Missing155125280
Body Mass Index
Body Mass Index(kg/m2)Physical Activity InterventionUsual Activity ControlTotal
Mean28.0 ± 5.828.0 ± 5.828.0 ± 5.8
Physical Function
Physical Function(Score)Physical Activity InterventionUsual Activity ControlTotal
Mean69.8 ± 25.670.0 ± 25.669.9 ± 25.6

9 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 33433559 ↗
  • 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. PubMed 38344760 ↗
  • 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. PubMed 35691486 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 27, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02425345
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
University of California, San Diego, Stanford University, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
Apr 2, 2015
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Results posted
May 13, 2026
Last update
Jul 31, 2026

Study contacts

Charles L Kooperberg, PhD
principal investigator · Fred Hutchinson Cancer Center
Andrea Z LaCroix, PhD
principal investigator · University of California, San Diego
Marcia L Stefanick, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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