Plain English Summary
Background and study aims:
If cardiovascular risk factors are identified early, cardiovascular disease can be prevented. Exercise has positive effects on many cardiovascular risk factors, and it can significantly reduce the components of metabolic syndrome. The main challenge with exercise, is how to motivate the patients to change and increase their exercise habits. Our aim is to modify the exercise habits of men in early middle age.
Who can participate?
Men aged 35 to 45 years with a high cardiovascular risk (with at least two risk factors). We plan to recruit 300 participants in a two year period.
What does the study involve?
We aim to modify the exercise habits of men in early middle age. The men will be allocated to either health promotion led by a public health nurse, or group exercise with health promotion led by a general practitioner. We predict that the treatments will have a beneficial effect on cardiovascular risk level and physical activity of the men, which are the main outcomes of the study. We will examine the effect of the two treatments on the individual risk factors of metabolic syndrome (e.g. weight, waist circumference, blood cholesterol level) and on the physical activity factors. The results of this study will help to plan the treatments used in future to reduce cardiovascular mortality.
What are the possible benefits and risks of participating?
The possibility to start physical training in a socially convenient surrounding with same-aged men having similar type of health problems. Main risk is that present intervention may not be strong enough to induce health benefits.
Where is the study run from?
The study will be run in Vantaa city, Finland by University of Helsinki and health authorities of Vantaa city.
When is study starting and how long is it expected to run for?
The study will start on 01 August 2012 and it will end 2015.
Who is funding the study?
Vantaa City, University of Helsinki and Yrjö Jahnssons Foundation.
Who is the main contact?
Timo Kauppila
timo.kauppila@helsinki.fi
Trial website
Contact information
Type
Scientific
Primary contact
Dr Timo Kauppila
ORCID ID
Contact details
Finnish Medical Network
Liusketie 19 D 23
Helsinki
00710
Finland
+358 447 684 449
timo.kauppila@fimnet.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCT5099201109
Study information
Scientific title
An exercise intervention compared to a health promotion intervention in 35 - 45 year old men with elevated cardiovascular risk: a randomized controlled trial
Acronym
EFFEXINCARR40
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
Hospital District of Helsinki and Uusimaa (HUS) Ethics Committee, 31 October 2011, ref: 213/13/03/00/11
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
http://www.vantaa.fi/mies40 [Available in Finnish, English, Russia 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: A health promotion intervention of 1 hour by a physician, followed an exercise course of 12 sessions in a group of men.
2. Control group: Health promotion intervention by a nurse practitioner for 1 hour. 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
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Cardiovascular risk assessed as FINNrisk 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. Body composition 0, 3 and 12 months
4. Use of health services
Overall trial start date
01/08/2012
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 35 45 years
2. At least two cardiovascular risk factors of the following:
2.1. BMI 27.0 - 34.0 Kg/m²
2.2. Waist circumference > 94 cm
3. Fasting glucose < 6.1 mmHg/l
4.Total plasma cholesterol >4 mmHg/l
5. LDL-cholesterol > 3.0 mmHg/l
6. Triglycerides >2.0 mmHg/l
7. Blood pressure > 140/90 mmHg
8. Currently engaged with:
8.1. Smoking
8.2. Cholesterol-lowering medication
8.3. Blood pressure-lowering medication
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
300
Participant exclusion criteria
1. BMI over 34 (or any other physical barrier that prevents participation in the exercise intervention)
2. Active exerciser (exercises 3 times a week or more)
3. Carrier of an immediate health problem requiring treatment or a severe risk factor; for example, recently diagnosed or uncontrolled type I diabetes, or a symptomatic coronary artery disease.
Recruitment start date
01/08/2012
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Finland
Trial participating centre
Finnish Medical Network
Helsinki
00710
Finland
Sponsor information
Organisation
Finnish Medical Network (Finland)
Sponsor details
c/o Dr Timo Kauppila
Liusketie 19 D 23
Helsinki
00710
Finland
Sponsor type
Research organisation
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
Basic results (scientific)
Publication list