Trial results for a physical activity intervention in older women, including data on Peripheral Artery Disease, were posted on 2026-05-13. The study found no significant difference in Peripheral Artery Disease incidence, with a Hazard Ratio of 1.04 (p=0.67), between the physical activity intervention and usual activity control groups.
Background
Peripheral Artery Disease (PAD) is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs. It can lead to pain, numbness, and other complications, increasing the risk of heart attack and stroke. Lifestyle interventions, including physical activity, are often recommended for managing PAD and improving overall cardiovascular health. This trial, the Women's Health Initiative Strong and Healthy Study (WHISH), broadly aimed to assess the impact of a physical activity intervention on various health outcomes in a large cohort of older U.S. women, including cardiovascular events, physical function, and bone health. The intervention sought to deliver physical activity guidance using behavioral principles and technology without face-to-face contact.
Trial design
This completed study, identified as Phase NA, enrolled 49331 participants. The trial investigated a physical activity intervention in older U.S. women, focusing on outcomes such as Myocardial Infarction, Stroke, Cardiovascular Mortality, Hip Fractures, and Falls. Peripheral Artery Disease was also a key outcome measured. The intervention involved providing physical activity materials and recommendations, including NIA Go4Life® Exercise & Physical Activity materials, to achieve nationally recommended levels of physical activity and overcome barriers to exercise, with a means for self-monitoring and setting personal goals. This was compared against a Usual Activity Control group. Primary outcomes were not specified in the posted results.
Key results
The trial results indicate the following for key measured outcomes:
- Peripheral Artery Disease: In the Physical Activity Intervention group, 217 participants experienced Peripheral Artery Disease, compared to 211 participants in the Usual Activity Control group. The Cox Regression analysis showed a Hazard Ratio of 1.04 (95% Confidence Interval: 0.86 to 1.26), with a p-value of 0.67, indicating no statistically significant difference.
- Physical Function (Self-report, RAND-36): Participants in the Physical Activity Intervention group had a mean physical function score of 59.73 (Standard Deviation: 26.76), while the Usual Activity Control group had a mean score of 58.73 (Standard Deviation: 26.82). Linear Regression analysis showed a Mean Difference of 0.91 (95% Confidence Interval: 0.46 to 1.37), with a p-value of 0.001, suggesting a statistically significant improvement in physical function with the intervention.
- Falls / Year: The Physical Activity Intervention group reported a mean of 0.55 falls per year (Standard Deviation: 0.59), compared to 0.57 falls per year (Standard Deviation: 0.60) in the Usual Activity Control group. A Poisson regression model indicated a Mean Difference of -0.03 (95% Confidence Interval: -0.06 to -0.01), with a p-value of 0.004, suggesting a statistically significant reduction in falls.
- Cardiovascular Events (Composite Myocardial Infarction, Stroke, Cardiovascular Mortality): There were 5231 events in the Physical Activity Intervention group and 5324 in the Usual Activity Control group. The Hazard Ratio was 0.99 (95% Confidence Interval: 0.95 to 1.02), with a p-value of 0.49, showing no statistically significant difference.
- Non-Cardiovascular Disease Mortality: 6336 participants in the Physical Activity Intervention group experienced non-cardiovascular disease mortality, compared to 6310 in the Usual Activity Control group. The Hazard Ratio was 1.0 (95% Confidence Interval: 0.97 to 1.04), with a p-value of 0.85, indicating no statistically significant difference.
- Hip Fracture: 1809 participants in the Physical Activity Intervention group experienced hip fracture, compared to 1813 in the Usual Activity Control group. The Hazard Ratio was 1.0 (95% Confidence Interval: 0.94 to 1.07), with a p-value of 0.96, showing no statistically significant difference.
What this means
For patients with Peripheral Artery Disease, these results suggest that the specific physical activity intervention studied did not significantly alter the incidence of PAD. However, the trial did demonstrate statistically significant benefits in improving overall physical function and reducing the rate of falls among older women. These broader findings are important for public health recommendations, highlighting the potential for physical activity interventions to enhance quality of life and reduce injury risk in older adults, even if a direct impact on PAD incidence was not observed in this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT02425345, titled "Women's Health Initiative Strong and Healthy Study", were posted on 2026-05-13 on clinicaltrials.gov.