Abstract

Introduction: Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for the secondary prevention in patients with ischemic stroke (IS) is inadequately defined. We assessed the hypothesis that lifestyle intervention which comprised exercise, salt reduction and nutrition advice could reduce new onset of vascular events in patients with mild IS. Methods: We conducted a single-blind randomized controlled trial that enrolled 66 patients (45 men, 21 women; mean age, 63.5 yo) with acute mild ischemic stroke. The patients were randomly allocated to a lifestyle intervention group (n = 33) or control group (n = 33). We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. The primary endpoint was ospitalization due to stroke recurrence and new onset of coronary heart disease. We also evaluated blood pressure, serum lipid profile and hemoglobin A1c to compare the efficacy of the lifestyle modification intervention. Results: This trial was terminated earlier than expected because the prespecified early stopping rule for efficacy had been met. After 24 weeks intervention period, the intervention group showed a significant decrease in the clinic and home blood pressure and significant increase in the high density lipoprotein cholesterol (HDL-C) levels from the baseline to the 6-month assessment (clinic and home SBP, P <0.001; HDL-C, P =0.018), with significant differences between the randomized groups (clinic and home SBP, P <0.001; HDL-C, P =0.022). Median duration of follow-up was 2.9 years, 12 patients allocated the control group and 1 patient allocated the lifestyle intervention group had at least one major vascular event. A sequential plans analysis indicated that lifestyle intervention superior to control in interim analysis. Kaplan-Meier survival curves after log-rank test showed significant prognostic difference between randomized groups ( P =0.005). Conclusions: In conclusion, the results of this study indicate that lifestyle intervention is beneficial for preventing stroke recurrence and other vascular events.

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