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.
Trial 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. Read more about this study
- 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
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Stanford University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Charles L Kooperberg, PhD, Principal investigator, Fred Hutchinson Cancer CenterAndrea Z LaCroix, PhD, Principal investigator, University of California, San DiegoMarcia L Stefanick, PhD, Principal investigator, Stanford University
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 33433559Mendoza-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 38344760Stefanick 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