Condition category
Circulatory System
Date applied
16/02/2010
Date assigned
20/05/2010
Last edited
29/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kirkkonummi.fi/mies40

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

  1. 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.

  2. 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.

Additional files

Editorial Notes