An interventional study of SNP and High Intensity Interval Training (HIIT) in Exercise, sponsored by University of Primorska. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by University of Primorska · Not applicable, Interventional, and Treatment
Among 22 studies in Motor Activity with a site in Slovenia — 4 open to participants now, 6 under way, none of them phase 3. Motor Activity · Slovenia.
Among the 22 studies in Motor Activity with a site in Slovenia, this one has the largest planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2017, is one of 14 with no phase, and was the 4th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →4 of the 22 studies in Motor Activity with a site in Slovenia are open now. Recruiting first, the newest first:
University Medical Centre Ljubljana · Sites in Slovenia
University Medical Centre Ljubljana · Sites in Slovenia
Nutrition Institute, Slovenia · Sites in Slovenia
University Hospital Schleswig-Holstein · Sites in Slovenia, Denmark, Georgia and 1 more country
A study can be open while its sites in Slovenia have not opened yet or have stopped. Only those recruiting at a site in Slovenia →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2017.
This study's planned enrollment of 500 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 45 across the 15 interventional studies, 217 across the 7 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 22 have an industry lead sponsor. The 10 most frequent:
University of Primorska is the lead sponsor of 56 studies on the registry; 7 are open to participants now.
University of Primorska has 5 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
4 of the studies in Motor Activity with a site in Slovenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06722989University Medical Centre LjubljanaThe Impact of Mobile Application-guided Physical Exercise on Physiological Parameters in Healthy Pregnant Women | 2026-12-31 |
| NCT06745817Nutrition Institute, SloveniaChallenges in Achieving Adequate Dietary Status of Women | 2026-12-31 |
| NCT07627022University Hospital Schleswig-HolsteinImpact of a Reminder App on Physical Activity During Radiation Therapy for Lung Cancer | 2027-02-15 |
| NCT07771023University Medical Centre LjubljanaEffects of Exercise in Patients With Repaired Coarctation of the Aorta | 2027-10 |
Among the 22 studies in Motor Activity with a site in Slovenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Athlete status is a heritable trait that could be explained with a number of potentially important DNA polymorphisms contributing to predisposition to success in certain types of sport.
The first aim of the study is to determine the genetic profile of Slovenian athletes. The associations of 30 common gene polymorphisms with aerobic and anaerobic athlete status will be investigated as a single and polygenic profile.
The second aim is to investigate the impact of the genetic variants contributing to different acute response to low vs. high intensity exercise. Physiological and biochemical measurements will be carried out. Variability in physiological adaptation in response to exercise will provides an opportunity to study the relationship between the molecular response to exercise and the extent of physiological changes in athletes. Currently, it is not yet clear whether different genetic variant associated with exercise responses remains uniform, with different exercise intensities, structure and duration of exercise.
Slovenian athletes (n = 300; 18-40 years) of regional or national competitive standard will be recruited from the endurance oriented and power oriented sports disciplines. Healthy unrelated individuals without any competitive sport experience will serve as controls (n= 200; 18-40 years). After completing the questionnaire (for athletes: covering demographics, geographic ancestry, sports classification, discipline, and history, as well as frequency and volume of training; for control group: demographics, geographic ancestry habits of daily living), genotyping analyses will be performed. The athletes and controls will be genotyped for 30 candidate gene polymorphisms considered likely to influence endurance performance. Molecular genetic analysis will be performed with DNA samples obtained from the capillary whole blood. Genotyping for 30 gene polymorphisms will be performed by Real-Time PCR on LightCycler® 96 Instrument (Roche) and KASP (Kompetitive Allele Specific PCR) genotyping technology.
In addition, 40 athletes with endurance genetic variant will be selected to participate in the acute exercise study. In order to investigate the acute effects of low and high intensity exercise the concentration of circulating myokines will be measured.
Three distinct experimental sessions scheduled 96 h apart, at the same time of the day and in random order will be applied to this sub-group of athletes.
In the first session, aerobic power will be determined using an incremental test to exhaustion on a cycling ergometer (Velodyn, Racermate ™, USA). Oxygen consumption (VO2) will be determined breath by breath using a Quark gas analysis system (Quark, Cosmed, Rim, Italy). The interventions during the other two experimental session will consist of cycling exercise with continuous 60 min cycling at 50% PPO (low intensity), and 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W) exercise (high intensity).
The participants will be asked to follow the prescribed diet regime, to avoid the intake of alcohol and to not perform any physical activity in the 24 hours prior to the experimental sessions. The experimental sessions will be performed from 8 to 11 am, in random order and scheduled 96 h apart.
Before each intervention, the individuals will remain seated in the laboratory for a period of 20 minutes with a room temperature between 22-24ºC. During this period, resting blood samples will be collected. Two more samples of blood will be collected, immediately post-exercise intervention and 2h post-exercise. Venous blood will be collected into EDTA tubes, centrifuge at 2500-3000g for 20 minutes, and a separate plasma will be stored at -80 ° C for the further analysis.
The quantification of biomarkers will be done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore). For the myokine analysis a commercial kit HMYOMAG-56K will be used.
Genotype distribution and allele frequencies between each of the two groups of athletes (endurance and power) and controls will be compared using χ2 tests. Endurance genotype score (EGS) will be construct. First, each genotype will be scored within each polymorphism. Thus, a genotype score (GS) of 2, 1 and 0 to each individual genotype theoretically associated to highest, medium or lowest potential of endurance phenotypes will be assigned. Second, the GS of each single genotype will be summed ∑(i=1)\^nSNPi. Third, the EGS will be transformed to a 0-100 scale for easier interpretation, as follows: EGS=(100/2n)∑_(i=1)\^nSNPi. An EGS of 100 represents an 'optimal' polygenic profile for endurance athlete-that is, that all GS are 2. In contrast, an EGS of 0 represents the 'worst' possible profile for endurance athlete, that is, all GS are 0. The mean the EGS obtained in the three study groups will be calculated. The EGS of endurance, power athletes and non-athletes (controls) will be compared with one-way analysis of variance (ANOVA), and Tukey post hoc test will be used for between-group comparisons. We will also performed ANOVA to compare the EGS between elite- and national-level athletes within each group of endurance and power athletes. Data normality was verified through an exploratory analysis using the Shapiro-Wilk test. Two-way mixed ANOVA will be applied to check the main interaction effects of time by exercise session (time*session) and of time (time) on myokine plasma concentration. For statistically significant effects, a post-hoc Tukey test will be adopted for multiple comparisons. All values will be expressed as mean and standard deviation (SD). P values of \<0.05 will be considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the first part the Case-control study design will be used to estimate the association between multiple single-nucleotide polymorphisms (SNPs) and the endurance/power athlete status.
Other: SNP
High intensity interval exercise on the cycling ergometer (Velodyn, Racermate ™, USA). Protocol: 8 x 5 min at 80% PPO (between intervals 1.5 min at 75 W). Baseline measurements will include the V̇O2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy).
Other: High Intensity Interval Training (HIIT)
Low intensity continuous exercise on the cycling ergometer (Velodyn, Racermate ™, USA). Protocol: continuous 60 min cycling at 50% PPO. Baseline measurements will include the V̇o2peak test and peak power output. Monitoring of physiological responses with spirometry and analysis of expired air (oxygen and carbon dioxide output) (Quark, Cosmed, Rim, Italy).
Other: Low Intensity Continuous Training
Screening 150 endurance, 150 power athletes, and 200 healthy control individuals for genetic variant associated to sport performance.
The subgroup (n = 40) of the athletes will participate in the acute exercises (HIIT Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory at least three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
The subgroup (n = 40) of the athletes will participate in the acute exercises (LIT Continuous Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
Genetic markers associated with endurance performance
Comparing the frequencies of the alleles of the candidate genes between endurance athletes and opposite cohorts (controls, power athletes).
Time frame: 12 weeks
Concentration of circulating myokines
The effect of exercise on expression of myokine between different exercise (high and low intensity exercise).
Time frame: 12 weeks
Plan to share: No
Start is estimated for Oct 2017; primary completion for Dec 2017, 2 months later.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 2 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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University of Primorska