Dose-Responses to EXercise TRAining: a randomised controlled four year trial on the effects of regular physical exercise and diet on endothelial function, atherosclerosis and cognitive function
| ISRCTN | ISRCTN45977199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45977199 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/09/2006
- Registration date
- 13/09/2006
- Last edited
- 01/11/2016
- 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
Prof Rainer Rauramaa
Scientific
Scientific
Kuopio Research Institute of Exercise Medicine
Haapaniementie 16
Kuopio
FIN-70100
Finland
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Dose-Responses to EXercise TRAining: a randomised controlled four year trial on the effects of regular physical exercise and diet on endothelial function, atherosclerosis and cognitive function |
| Study acronym | DR's EXTRA |
| Study objectives | 1. Regular aerobic or resistance exercise causing an energy expenditure of 1000 - 1500 kcal/wk (4.2 - 6.3 MJ/wk) reduces the risk of developing metabolic syndrome and type two diabetes, attenuates inflammation, improves endothelial function, diminishes the progression of atherosclerosis, and decreases the risk of cognitive impairment, without additional benefit from higher exercise energy expenditures. 2. Regular aerobic or resistance exercise enhances Nitric Oxide (NO) bioavailability as a consequence of the down-regulation of the modified RiboNucleic Acid (mRNA) of inducible NO Synthase (iNOS), and this effect can be seen as an improved Flow-Mediated Dilatation (FMD) of the brachial artery. 3. Regular aerobic exercise generates muscle specific InterLeukin-6 (IL-6), which induces an anti-inflammatory response by elevating the levels of anti-inflammatory cytokines, reflected by lowering of high sensitivity C-Reactive Protein (hsCRP), and seen as improved FMD of the brachial artery. 4. Regular aerobic or resistance exercise enhance the levels of mitochondrial proteins and further enhance the expression of metabolic genes during acute exercise and thereby improves insulin sensitivity and glucose tolerance. 5. Low saturated fat, high unsaturated fat, high fiber diet, enriched with omega-3 fatty acids, attenuates inflammatory reaction by down-regulating the mRNA of iNOS and Heat Shock Protein HSP72 thereby improving endothelial function, diminishing the progression of atherosclerosis, and decreasing the risk of cognitive impairment. 6. Combined exercise and diet intervention is more powerful for attenuation of inflammatory reaction, improving endothelial function, diminishing the progression of atherosclerosis, and decreasing the risk of cognitive impairment than exercise or diet alone. |
| Ethics approval(s) | Joint ethics committee of Kuopio University and Kuopio University Hospital |
| Health condition(s) or problem(s) studied | Endothelial function, atherosclerosis |
| Intervention | Participants are randomly allocated into: 1. Control group 2. Aerobic exercise 3. Resistance exercise 4. Diet 5. Combined aerobic exercise and diet 6. Combined resistance exercise and diet |
| Intervention type | Behavioural |
| Primary outcome measure | Changes in: 1. Atherosclerosis 2. Endothelial function 3. Cognitive function |
| Secondary outcome measures | Changes in: 1. Inflammatory status 2. Metabolic risk factors 3. Cardiovascular risk factors |
| Overall study start date | 15/01/2003 |
| Completion date | 15/09/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1500 |
| Key inclusion criteria | A random population sample of the citizens in Kuopio, aged 55 to 74 years at the time of recruitment |
| Key exclusion criteria | Conditions that inhibit safe engagement in prescribed exercise training, malignant diseases and other conditions preventing co-operation, as judged by the research physicians. |
| Date of first enrolment | 15/01/2003 |
| Date of final enrolment | 15/09/2010 |
Locations
Countries of recruitment
- Finland
Study participating centre
Kuopio Research Institute of Exercise Medicine
Kuopio
FIN-70100
Finland
FIN-70100
Finland
Sponsor information
Ministry of Education (Finland)
Government
Government
PO Box 29
Helsinki
00023
Finland
| Website | http://www.minedu.fi |
|---|---|
"ROR" |
https://ror.org/02w52zt87 |
Funders
Funder type
Government
Ministry of Education in Finland (Finland) (refs: 125/722/2003; 116/722/2004; 134/627/2005)
No information available
Academy of Finland (Finland) (refs: 102318;104943)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Kuopio University Hospital (Finland) (refs: 13/2002; 24/2004)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Kuopio University Hospital, KYS
- Location
- Finland
Diabetes Research Foundation (Finland)
No information available
European Union (Belgium) - partner in EXGENESIS consortium (ref: EU 005272)
No information available
Sydäntutkimussäätiö
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Foundation for Cardiovascular Research
- Location
- Finland
Paivikki and Sakari Sohlberg Foundation (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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No | |
| Results article | prediabetic states results | 01/07/2012 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No | |
| Results article | results | 14/11/2014 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | results | 01/11/2015 | Yes | No |
Editorial Notes
01/11/2016: Publication reference added.
