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Open Access Highly Accessed Study protocol

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

Svetlana From1*, Helena Liira1, Jenni Leppävuori2, Taina Remes-Lyly3, Heikki Tikkanen2 and Kaisu Pitkälä1

Author Affiliations

1 Helsinki University Central Hospital, Unit of Primary Health Care and University of Helsinki, Department of General Practice and Primary Health Care, Helsinki, Finland

2 Department of Sports and Exercise Medicine, University of Helsinki and Foundation of Sports and Exercise Medicine, Helsinki, Finland

3 Kirkkonummi Health Center, Kirkkonummi, Finland

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BMC Public Health 2013, 13:125  doi:10.1186/1471-2458-13-125

Published: 11 February 2013

Abstract

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 webcite). 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).

Keywords:
Exercise intervention; Health promotion; Metabolic syndrome; Exercise activity