Stroke Clinical Trial
— WHISHOfficial title:
Women's Health Initiative Strong and Healthy Study
Verified date | March 2024 |
Source | Fred Hutchinson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 49331 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 66 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Center | National Heart, Lung, and Blood Institute (NHLBI), Stanford University, University of California, San Diego |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality | Adjudicated events | 9 years | |
Primary | Non-Cardiovascular Disease Mortality | Safety; adjudicated event | 9 years | |
Primary | Hip Fracture | Safety; adjudicated event | 9 years | |
Primary | Clinical (non-hip) Fracture | Safety | 9 years | |
Primary | Falls | Safety; self-report | 9 years | |
Secondary | Venous Thromboembolic Event | Adjudicated event | 9 years | |
Secondary | Peripheral Artery Disease | Adjudicated event | 9 years | |
Secondary | 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. | 9 years | |
Secondary | 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. | 9 years | |
Secondary | Coronary Revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention) | Safety; adjudicated events | 9 years | |
Secondary | 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. | 4 years | |
Secondary | 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. | 4 years | |
Secondary | 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. | 4 years |
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