title: Effectiveness of exercise intervention and health promotion on cardiovascular risk factors in middle-aged men: a protocol of a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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).
  
  
  BACKGROUND
  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).
authors: Helsinki University Central Hospital, Unit of Primary Health Care and University of Helsinki, Department of General Practice and Primary Health Care, Helsinki, Finland. svetlana.from@helsinki.fi.
authors: Svetlana
authors: S
authors: From
authors: Helena
authors: H
authors: Liira
authors: Jenni
authors: J
authors: Leppävuori
authors: Taina
authors: T
authors: Remes-Lyly
authors: Heikki
authors: H
authors: Tikkanen
authors: Kaisu
authors: K
authors: Pitkälä
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D015444:Exercise; D005081:Exercise Therapy; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D024821:Metabolic Syndrome / Q000517:prevention & control*; D008875:Middle Aged; D009042:Motivation; D009765:Obesity / Q000517:prevention & control; D017063:Outcome Assessment, Health Care; D011320:Primary Health Care; D012107:Research Design; D012111:Residence Characteristics; D012307:Risk Factors
references: PLoS One. 2009;4(4):e5195
references: 19365563
references: Am J Cardiol. 2007 Dec 15;100(12):1759-66
references: 18082522
references: BMC Fam Pract. 2011 Sep 13;12:95
references: 21914190
references: Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003054
references: 18646086
references: BMC Public Health. 2007 Sep 19;7:249
references: 17877832
references: JAMA. 2011 May 4;305(17):1790-9
references: 21540423
references: J Nutr Health Aging. 2001;5(3):150-4
references: 11458284
references: Lancet. 2008 Jun 14;371(9629):1999-2012
references: 18555911
references: Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003817
references: 17054187
references: Cochrane Database Syst Rev. 2011 Jan 19;(1):CD001561
references: 21249647
references: Can Fam Physician. 2008 Dec;54(12):1706-13
references: 19074715
references: Circulation. 2009 Oct 20;120(16):1640-5
references: 19805654
references: CMAJ. 2009 Dec 8;181(12):E267-74
references: 19948811
references: N Engl J Med. 2001 May 3;344(18):1343-50
references: 11333990