Condition category
Oral Health
Date applied
03/01/2011
Date assigned
28/07/2011
Last edited
31/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

http://www.kirkkonummi.fi/mies40

Contact information

Type

Scientific

Primary contact

Dr Helena Liira

ORCID ID

Contact details

University of Helsinki
Kuninkaantie 4
Kirkkonummi
02400
Finland
+358 (0)50 577 1351

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Association of periodontal infection with cardiovaskular risks

Acronym

EHP

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 dental periodontal health of the men.

Ethics approval

The coordinating ethics committee at Helsinki University Hospital approved on the 8th June 2009, ref: 4/13/03/00/09

Study design

Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

http://www.kirkkonummi.fi/mies40. Patient information sheets will be available in Finnish and Swedish

Condition

Men's general health and dental periodontal health

Intervention

Participants will be randomised into one of two groups:
1. Exercise intervention: First a health promotion intervention of 1h 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 1h
Cardiovascular and diabetes risks are assessed and the consultation focuses on perceived risk behaviour
3. The control group will receive the exercise intervention after one year
4. All groups are followed up after 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Exercise activity and general health indicators and periodontal health’s indicators

Secondary outcome measures

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

University of Helsinki
Kirkkonummi
02400
Finland

Sponsor information

Organisation

Universty of Helsinki (Finland)

Sponsor details

c/o Dr Helena Liira
Kuninkaantie 4
Kirkkonummi
02400
Finland
+358 (0)50 577 1351
helena.liira@helsinki.fi

Sponsor type

University/education

Website

http://www.helsinki.fi/university/

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

Publication citations

Additional files

Editorial Notes