Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helena Liira
ORCID ID
Contact details
Kuninkaantie 4
Kirkkonummi
02400
Finland
+358 (0)50 5771351
helena.liira@helsinki.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCTXXX
Study information
Scientific title
Exercise intervention as compared to health promotion intervention in 35-45 year old men at elevated cardiovascular risk: a randomised controlled trial
Acronym
EIHP
Study hypothesis
Exercise is an effective method to control the cardiovascular risk in men. The challenge is to change the exercise habits of men. In this study we aim to modify the exercise habits by a exercise intervention in a group and by a health promotion intervention by a nurse. We hypothesize that the interventions have effect on the cardiovascular risk level of the men.
Ethics approval
The coordinating ethics committee at Helsinki University Hospital, 08/06/2009, ref: 4/13/03/00/09
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
More information may be found at http://www.kirkkonummi.fi/mies40. Patient information sheets will be available in Finnish and Swedish
Condition
Men at elevated cardiovascular risk (at least two risk factors, please see above)
Intervention
Participants will be randomised into one of two groups:
1. Exercise intervention: First a health promotion intervention of 1 h by a nurse practitioner, followed an exercise course of 12 sessions in a group of men.
2. Control group: Health promotion intervention by a nurse practitioner of 1 h. Cardiovascular and diabetes risks are assessed and the consultation focuses on perceived risk behaviour.
The control group will receive the exercise intervention after one year.
All groups are followed up after 12 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Cardiovascular risk assessed as Framingham risk based on lab analysis of HDL, LDL-Cholesterol, relative risk (RR) and smoking habits measured at 0, 3 and 12 months
2. Exercise habits surveyed as exercise sessions per week at 0, 3, 6, and 12 months
Secondary outcome measures
1. Walking test, standardised UKK-walking test performed at 0, 3 and 12 months
2. Subjective well-being and health are measured on a continuous visual analogue scale (VAS) of 100mm at 0, 3, 6 and 12 months
3. Use of health services
Overall trial start date
06/06/2009
Overall trial end date
06/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male
2. Age 35 - 45 years
3. At least two cardiovascular risk factors of the following
3.1. BMI 27.0 - 34.0 kg/m²
3.2. Waist circumference > 94 cm
3.3. Fasting glucose < 6,1 mmHg/l
3.4. Total plasma cholesterol >4 mmHg/l
3.5. LDL-cholesterol > 3,0 mmHg/l
3.6. Triglycerides >2,0 mmHg/l
3.7. Blood pressure < 140/90 mm Hg
3.8. Currently engaging in/taking all of the following:
3.8.1. Smoking
3.8.2. Cholesterol-lowering medication
3.8.3. Blood pressure-lowering medication
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
300
Participant exclusion criteria
1. Exercise more then 3 times per week
2. BMI >34 kg/m²
3. Chronic conditions (alcoholism, unstable heart problem, severe mental problems)
Recruitment start date
06/06/2009
Recruitment end date
06/06/2011
Locations
Countries of recruitment
Finland
Trial participating centre
Kuninkaantie 4
Kirkkonummi
02400
Finland
Sponsor information
Organisation
University of Helsinki (Finland)
Sponsor details
c/o Helena Liira
Kuninkaantie 4
02400 Kirkkonummi
Kirkkonummi
02400
Finland
+358 (0)50 577 1351
helena.liira@helsinki.fi
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Helsinki (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23398957
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25434409
Publication citations
-
Protocol
From S, Liira H, Leppävuori J, Remes-Lyly T, Tikkanen H, Pitkälä K, Effectiveness of exercise intervention and health promotion on cardiovascular risk factors in middle-aged men: a protocol of a randomized controlled trial., BMC Public Health, 2013, 13, 1, 125, doi: 10.1186/1471-2458-13-125.
-
Results
Liira H, Engberg E, Leppävuori J, From S, Kautiainen H, Liira J, Remes-Lyly T, Tikkanen H, Pitkälä K, Exercise intervention and health checks for middle-aged men with elevated cardiovascular risk: a randomized controlled trial, Scand J Prim Health Care, 2014 , 32, 4, 156-162, doi: 10.3109/02813432.2014.984967.