Myocardial InfarctionWHISHNCT02425345

Women's Health Initiative Strong and Healthy Study

A study testing Physical Activity in people with Myocardial Infarction and Stroke, run by Fred Hutchinson Cancer Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 66 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Myocardial Infarction, Stroke, Cardiovascular Mortality
What is being tested?: Physical Activity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49,331 participants
Where: No sites listed yet
Study dates: 2 Apr 2015to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 66 to 99 years
Women only
Healthy volunteers accepted
Older adult

Who may be able to join

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)

Who cannot join

Inability to walk
Dementia
Residing in a nursing home

About this study

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.

Conditions: Myocardial Infarction, Stroke, Cardiovascular Mortality, Hip Fractures, Falls, Mortality
Being tested: Physical Activity
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
Medical subject headings: Myocardial Infarction, Stroke, Hip Fractures, Peripheral Arterial Disease, Fractures, Bone, Depression, Motor Activity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical ActivityBehavioural
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.

Study groups in NCT02425345
Study group	Role	What they receive
Physical Activity Intervention	Experimental	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 Receives: Behavioral: Physical Activity
Usual Activity Control	No intervention	Usual activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: median 8.7 years
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.
Measured: 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.
Non-Cardiovascular Disease Mortality
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Measured: median 8.7 years
Hip Fracture
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Measured: median 8.7 years
Falls / Year
Safety; self-report
Measured: median 8.7 years
Clinical (Non-hip) Fracture
Safety. Self-report
Measured: median 8.7 years

Secondary outcomes (7)

Peripheral Artery Disease
WHI centrally adjudicated events and CMS FFS-identified events.
Measured: median 8.7 years
Venous Thromboembolic Event
WHI centrally adjudicated events and CMS FFS-identified events.
Measured: median 8.7 years
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
Safety; adjudicated events
Measured: median 8.7 years
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.
Measured: median 8.7 years
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.
Measured: One time per participant analyzed during study year 7, 8, or 9.
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.
Measured: Annually during study years 6, 7, 8, and 9. The single value for this Outcome is based on the average of all collected measurements.
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.
Measured: Annually during study years 6, 7, 8, 9. The single value for this Outcome is based on the average of all collected measurements.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 201531 Dec 2024

First posted24 Apr 2015 (estimated)
Study start2 Apr 2015
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 49,331 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425345
Sponsor's protocol ID: 4R33HL151885-02
Other IDs: 1U01HL122280-01A1, 1U01HL122273-01A1, RG1001184
Acronym: WHISH
Status last verified: Apr 2026
First submitted: 16 Apr 2015
Last updated: 31 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
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Not yet recruitingObservational study
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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Women's Health Initiative Strong and Healthy Study
ClinicalTrials.gov ID: NCT02425345
Acronym / sponsor ID: WHISH / 4R33HL151885-02
Conditions: Myocardial Infarction, Stroke, Cardiovascular Mortality, Hip Fractures, Falls, Mortality
Keywords: Physical Activity, National Institute of Aging Go4Life, Postmenopausal Women, Balance, Strength, Exercise, Cardiovascular Disease, Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 49,331 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: University of California, San Diego, Stanford University, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 2 Apr 2015 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 24 Apr 2015 (estimated)
Results: Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Physical Activity Intervention	Experimental	Behavioral: Physical ActivityThe 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 Control	No intervention	–Usual activity

Who may qualify

Ages: 66 to 99 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (3 listed)

Inability to walk
Dementia
Residing in a nursing home

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical ActivityThe 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.	Behavioural	Physical Activity Intervention

Primary outcome

Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality
Time frame: 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.
Physical Function (Physical Function Score From Self-report, RAND-36)
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.
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.
Non-Cardiovascular Disease Mortality
Time frame: median 8.7 years
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Hip Fracture
Time frame: median 8.7 years
Safety. WHI centrally adjudicated events and CMS FFS-identified events.
Falls / Year
Time frame: median 8.7 years
Safety; self-report
Clinical (Non-hip) Fracture
Time frame: median 8.7 years
Safety. Self-report

7 secondary outcomes

Peripheral Artery Disease
Time frame: median 8.7 years
Venous Thromboembolic Event
Time frame: median 8.7 years
Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention)
Time frame: median 8.7 years
Mobility Loss
Time frame: median 8.7 years
Short Physical Performance Battery (SPPB)
Time frame: One time per participant analyzed during study year 7, 8, or 9.
Sleep Disturbance
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.
Depressive Symptoms
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.

Results and safety

Results posted to the registry on 13 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Physical Activity Intervention	24,657	24,657
Usual Activity Control	24,674	24,674

Primary outcome: Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality

Time frame: median 8.7 years. Count of participants. Unit: Participants

Measure	Physical Activity Intervention n = 24657	Usual Activity Control n = 24674
Value	5231	5324

Physical Activity Intervention vs Usual Activity Control: Hazard Ratio (HR): 0.99 (95% CI 0.95 to 1.02), p = 0.49, Regression, Cox

Primary outcome: Physical Function (Physical Function Score From Self-report, RAND-36)

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.. Mean (Standard Deviation). Unit: Score

Measure	Physical Activity Intervention n = 24657	Usual Activity Control n = 24674
Value	59.73 (26.76)	58.73 (26.82)

Physical Activity Intervention vs Usual Activity Control: Mean Difference (Final Values): 0.91 (95% CI 0.46 to 1.37), p <0.001, Regression, Linear

Primary outcome: Non-Cardiovascular Disease Mortality

Time frame: median 8.7 years. Count of participants. Unit: Participants

Measure	Physical Activity Intervention n = 24657	Usual Activity Control n = 24674
Value	6336	6310

Physical Activity Intervention vs Usual Activity Control: Hazard Ratio (HR): 1.00 (95% CI 0.97 to 1.04), p = 0.85, Regression, Cox

Primary outcome: Hip Fracture

Time frame: median 8.7 years. Count of participants. Unit: Participants

Measure	Physical Activity Intervention n = 24657	Usual Activity Control n = 24674
Value	1809	1813

Physical Activity Intervention vs Usual Activity Control: Hazard Ratio (HR): 1.00 (95% CI 0.94 to 1.07), p = 0.96, Regression, Cox

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: median 8.7 years. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Physical Activity Intervention	0 of 24,657 (0%)	0 of 24,657 (0%)	9,614 of 24,657
Usual Activity Control	0 of 24,674 (0%)	0 of 24,674 (0%)	9,697 of 24,674

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33433559Stefanick 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.
Derived from this study: PubMed 38344760Mendoza-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.
Derived from this study: PubMed 35691486Stefanick 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.
Women's Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline CharacteristicsLink provided by the sponsor.

Related trials for Myocardial Infarction

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity in people with Myocardial Infarction and Stroke, run by Fred Hutchinson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality (time frame: median 8.7 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425345, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.