PURPOSE: The effects of exercise in subjects with multiple cardiovascular risk factors (RF) have never been tested in a large-scale randomized controlled trial. The favorable results from our observational study led to this randomized controlled trial. METHODS: The participants, recruited from a community, were overweight, with two of the following three risk factors: hypertension, hyperlipidemia, or glucose intolerance (n = 561; 44% male; mean age (SD) 67 (6); mean BMI 26.4 (2.0)). All participants received a standard health exam with counseling, followed by randomization. The intervention group (INT) was to exercise two to four times per week for 6 months at a fitness club. RESULTS: Dropout rate was 11% for INT and 10% for the controls. INT exercised an average of 2.6 times per week. Among primary outcome measures, there was a marginally significant between-group difference in changes in systolic blood pressure (intervention minus control, -2.46 mmHg). Reductions in LDL cholesterol (-1.9 mgdL) and hemoglobin A1c (-0.042%) were not significant. Among secondary outcomes, between-group differences were significantly greater (p < 0.05) for INT in mean body weight (-1.60 kg), waist circumference (-1.8 cm), triglyceride (-7 mgdL), hsCRP (-0.063 mgL), and estimated VO2peak (2.0 mL/kg/min). All directional mean RF changes consistently favored INT. A cardiovascular risk reduction estimated from the changes in RF was about 24%. A greater improvement was also found in health-related quality-of-life measures (SF-36) in INT. No difference was found in the adverse event rate. CONCLUSIONS: Exercising an average of 2.6 times per week for 6 months produced a significant improvement in cardiovascular risk profile in subjects with multiple cardiovascular risk factors through cumulative results of modest yet pervasive changes in all conventional risk factors, without increased adverse effects.

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