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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 10.1186/ISRCTN45977199
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym DR's EXTRA
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval The Joint ethical committee of the Kuopio University and Kuopio University Hospital has approved the protocol.
Study design Controlled randomised trial
Countries of recruitment Finland
Disease/condition/study domain Endothelial function, atherosclerosis
Participants - inclusion criteria A random population sample of the citizens in Kuopio, aged 55 to 74 years at the time of recruitment
Participants - 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.
Anticipated start date 15/01/2003
Anticipated end date 15/09/2010
Status of trial Completed
Patient information material
Target number of participants 1500
Interventions Participants are randomly allocated into:
1. Control group, or into one of the following intervention groups
2. Aerobic exercise
3. Resistance exercise, or
4. Diet
5. Combined aerobic exercise and diet
6. Combined resistance exercise and diet
Primary outcome measure(s) Changes in:
1. Atherosclerosis
2. Endothelial function
3. Cognitive function
Secondary outcome measure(s) Changes in:
1. Inflammatory status
2. Metabolic risk factors
3. Cardiovascular risk factors
Sources of funding 1. Ministry of Education in Finland (Finland) (refs: 125/722/2003; 116/722/2004; 134/627/2005)
2. Academy of Finland (Finland) (refs: 102318;104943)
3. Kuopio University Hospital (Finland) (refs: 13/2002; 24/2004)
4. Diabetes Research Foundation (Finland)
5. European Union (Belgium) - partner in EXGENESIS consortium (ref: EU 005272)
6. Finnish Foundation for Cardiovascular Research (Finland)
7. Paivikki and Sakari sohlberg Foundation (Finland)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20413523
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21186108
3. 2012 prediabetic states results in http://www.ncbi.nlm.nih.gov/pubmed/22415336
Contact name Prof  Rainer  Rauramaa
  Address Kuopio Research Institute of Exercise Medicine
Haapaniementie 16
  City/town Kuopio
  Zip/Postcode FIN-70100
  Country Finland
Sponsor Ministry of Education (Finland)
  Address P.O.Box 29
  City/town Helsinki
  Zip/Postcode 00023
  Country Finland
  Sponsor website: http://www.minedu.fi
Date applied 06/09/2006
Last edited 07/11/2012
Date ISRCTN assigned 13/09/2006
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