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 mm Hg). Reductions in LDL cholesterol (−1.9 mg·dL−1) 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 mg·dL−1), hsCRP (−0.063 mg·L−1), and estimated V˙O2peak (2.0 mL·kg−1·min−1). 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.
1Sapporo Health Promotion Center, Sapporo, JAPAN; and 2Asai Hokusho University, Ebetsu, JAPAN
Address for correspondence: Hirotaka Nishjjima, MD, PhD, Sapporo Health Promotion Center, Minami-3 Nishi 11, Chuoku, Sapporo 060-0063, Japan; E-mail: email@example.com.
Submitted for publication September 2006.
Accepted for publication January 2007.