Exercise intervention and health checks for middle-aged men with elevated cardiovascular risk: a randomized controlled trial.

OBJECTIVE: To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk. DESIGN: A randomized controlled trial. SETTING AND INTERVENTION: Primary care in Kirkkonummi municipality with 36 000 inhabitants. A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared. SUBJECTS: A total of 168 men aged 35 to 45 years with at least two cardiovascular risk factors and physical activity (PA) frequency < 3 times a week. MAIN OUTCOME MEASURES: Metabolic syndrome (MetS) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency. RESULTS: Overall, focusing on health increased physical activity frequency in middle-aged men. After one year, 19% had increased PA to ≥ 3 times a week (95% CI 12-26). All study groups increased PA to ≥ 3 times: 26% of men in the exercise intervention group, 15% of men in the health check group, and 16% of controls. The differences between the groups were not statistically significant. The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up. CONCLUSIONS: Physical activity increased in all study groups of middle-aged men in this health-promotion trial. The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants. The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise services.

Effectiveness of exercise intervention and health promotion on cardiovascular risk factors in middle-aged men: a protocol of a randomized controlled trial.

BACKGROUND: Although cardiovascular disease has decreased, there is still potential for prevention as obesity and diabetes increase. Exercise has a positive effect on many cardiovascular risk factors, and it can significantly reduce the components of metabolic syndrome. The main challenge with exercise in primary care is how to succeed in motivating the patients at risk to change and increase their exercise habits. The objective of this study is to modify the cardiovascular risk in middle-aged men, either through a health promotion intervention alone or combined with an exercise intervention. METHODS/DESIGN: During a two-year period we recruit 300 men aged from 35 to 45 years with elevated cardiovascular risk (> two traditional risk factors). The men are randomized into three arms: 1) a health promotion intervention alone, 2) both health promotion and exercise intervention, or 3) control with usual community care and delayed health promotion (these men receive the intervention after one year). The main outcome measures will be the existence of metabolic syndrome and physical activity frequency (times per week). The participants are assessed at baseline, and at 3, 6, and 12 months. The follow-up of the study will last 12 months. DISCUSSION: This pragmatic trial in primary health care aimed to assess the effect of a health promotion programme with or without exercise intervention on cardiovascular risk and physical activity in middle-aged men. The results of this study may help to plan the primary care interventions to further reduce cardiovascular mortality.The study was registered at the Controlled Trials ( http://www.controlled-trials.com). TRIAL NUMBER: ISRCTN80672011. The study received ethics approval from the Coordinating Ethics Committee at Helsinki University Hospital on 8 June 2009 (ref: 4/13/03/00/09).