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
Protocol serial number N/A
Sponsor Ministry of Education (Finland)
Funders Ministry of Education in Finland (Finland) (refs: 125/722/2003; 116/722/2004; 134/627/2005), Academy of Finland (Finland) (refs: 102318;104943), Kuopio University Hospital (Finland) (refs: 13/2002; 24/2004), Diabetes Research Foundation (Finland), European Union (Belgium) - partner in EXGENESIS consortium (ref: EU 005272), Sydäntutkimussäätiö, Paivikki and Sakari Sohlberg Foundation (Finland)
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

Kuopio Research Institute of Exercise Medicine
Haapaniementie 16
Kuopio
FIN-70100
Finland

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDose-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 acronymDR's EXTRA
Study objectives1. 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) studiedEndothelial function, atherosclerosis
InterventionParticipants 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 typeBehavioural
Primary outcome measure(s)

Changes in:
1. Atherosclerosis
2. Endothelial function
3. Cognitive function

Key secondary outcome measure(s)

Changes in:
1. Inflammatory status
2. Metabolic risk factors
3. Cardiovascular risk factors

Completion date15/09/2010

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexAll
Target sample size at registration1500
Key inclusion criteriaA random population sample of the citizens in Kuopio, aged 55 to 74 years at the time of recruitment
Key exclusion criteriaConditions 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 enrolment15/01/2003
Date of final enrolment15/09/2010

Locations

Countries of recruitment

  • Finland

Study participating centre

Kuopio Research Institute of Exercise Medicine
Kuopio
FIN-70100
Finland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

01/11/2016: Publication reference added.

BMC - Part of Springer Nature Springer Nature