Persistent effect at 30-month post intervention of a community-based randomized trial of KM2H(2) in reducing stroke and heart attack among senior hypertensive patients

BACKGROUND: The effect of the Keep Moving toward Healthy Heart and Healthy Brain (KM2H2) program at 6-month post intervention has been assessed. The purpose of this study is to evaluate the KM2H(2) program at 30-month post intervention. METHODS: A total of 450 senior hypertensive patients from 12 community health centers were randomized by center to either receive KM2H(2) plus standard care (6 centers, n = 232) or standard care only (6 centers, n = 218). Data for outcome measures at 30-month post intervention were analyzed. New cases of stroke and heart attack were verified with medical records; levels of physical activity were assessed using self-reported questionnaire. In addition to comparative analysis, adjusted incidence rate and program effects were determined using mixed effects modeling method. RESULTS: At the 30-month follow-up, the adjusted incidence rate [95% CI] of stroke was 11.81% [5.90, 17.72] for patients in the intervention group and 19.78% [14.07, 25.50] (p = 0.03) for the control group. The adjusted incidence rate of heart attack was 3.34% [1.91, 8.58] and 6.68% [1.64, 11.73] for the intervention and control groups (p = 0.16), respectively; the proportion and the duration of engaging in regular physical activity were significantly greater for the intervention group than the control group. The reductions in blood pressure between the intervention and the control was not statistically significant. CONCLUSIONS: The KM2H(2) program showed a persistent effect up to 30 months post intervention in enhancing physical activity and reducing the risk of cardio-cerebrovascular events, particularly stroke. These findings demonstrate the persistent effect of the KM2H(2) and suggest the need for a full-scale evaluation of the intervention program for practical use. TRIAL REGISTRATION: ISRCTN Register ISRCTN12608966. Registered 03 March 2015. Retrospectively registered.