Exercise intervention as compared to health promotion intervention in 35-45 year old men at elevated cardiovascular risk
| ISRCTN | ISRCTN80672011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80672011 |
| Secondary identifying numbers | NCTXXX |
- Submission date
- 16/02/2010
- Registration date
- 20/05/2010
- Last edited
- 29/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helena Liira
Scientific
Scientific
Kuninkaantie 4
Kirkkonummi
02400
Finland
| Phone | +358 (0)50 5771351 |
|---|---|
| helena.liira@helsinki.fi |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | More information may be found at http://www.kirkkonummi.fi/mies40. Patient information sheets will be available in Finnish and Swedish |
| Scientific title | Exercise intervention as compared to health promotion intervention in 35-45 year old men at elevated cardiovascular risk: a randomised controlled trial |
| Study acronym | EIHP |
| Study objectives | 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(s) | The coordinating ethics committee at Helsinki University Hospital, 08/06/2009, ref: 4/13/03/00/09 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 06/06/2009 |
| Completion date | 06/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 300 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 06/06/2009 |
| Date of final enrolment | 06/06/2011 |
Locations
Countries of recruitment
- Finland
Study participating centre
Kuninkaantie 4
Kirkkonummi
02400
Finland
02400
Finland
Sponsor information
University of Helsinki (Finland)
University/education
University/education
c/o Helena Liira
Kuninkaantie 4
02400 Kirkkonummi
Kirkkonummi
02400
Finland
| Phone | +358 (0)50 577 1351 |
|---|---|
| helena.liira@helsinki.fi | |
"ROR" |
https://ror.org/040af2s02 |
Funders
Funder type
University/education
University of Helsinki (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/02/2013 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No |
