Physical ExertionPTSWNCT03990259
Penyagolosa Trail Saludable Women
An observational study of Physical Exertion, run by Universitat Jaume I at 1 site in Spain.
Trial summary
This study has as main objective to asses different genetic, biochemical and physiological biomarkers affecting performance and health status in ultraendurance runners according to individual's sex. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Exertion
- What is being tested?
- Running the CSP Mountain Race
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2019to 16 Apr 2019
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 ultraendurance amateur runners, 19 females and 31 males.
Who may be able to join
- Healthy adults (>18 years old)
- Volunteers should be finish at least one ultraendurance mountain race (>60km).
Who cannot join
- Having heart disease
- Having kidney disease
- Taking a medication on an ongoing basis
Trial locations and contacts
1 site in 1 country.
About this study
This study has as main objective to asses different genetic, biochemical and physiological biomarkers affecting performance and health status in ultraendurance runners according to individual's sex.
Read the detailed description
Ultraendurance races has been shown to impact on several health-related biomarkers, and therefore they may have detrimental effects on runners' health. In this study, we aim to analyze the impact of running a 107,6 km mountain race in ultraendurance runners splitting our sample by individual's sex.
To do this, baseline measurements of the runners have been collected through stress tests and biochemical analyses of blood and urine samples. Indeed, a saliva sample was collected to isolated a genomic DNA sample of each runner.
During the race anthropometrical, ventilatory and strength data was collected in three different moments and after crossing the finish line. Indeed, after completed the ultraendurance mountain race, blood and urine samples were taken at the finish line, as well as 24h and 48h post-race.
- Conditions
- Physical Exertion
- Being tested
- Running the CSP Mountain Race
- Keywords
- Ultraendurance, Sex differences, Performance, Genetics, Physiological damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running the CSP Mountain RaceOther
The runners completed a 107,6 km mountain race
| Study group | Role | What they receive |
|---|---|---|
| Male | The male individuals of the study population Receives: Other: Running the CSP Mountain Race | |
| Female | The female individuals of the study population Receives: Other: Running the CSP Mountain Race |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage
Blood concentration of estradiol, testosterone, progesterone, creatinine, troponin, C-reactive protein, hemoglobin, sodium, potassium, chlorine, iron, and ferritin. Concentration of all these parameters is expressed in mass per volume (i.e. nanograms per milliliter)
Measured: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Change in the biochemical parameters related to muscle damage
Blood concentration of lactate dehydrogenase and creatine kinase. The enzyme concentration is expressed in units per volume (enzyme units per milliliter)
Measured: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Change in the biochemical parameters related to immunological response
Blood concentration of erythrocytes, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet volume. The concentration of each cell type is expressed in number of cells per volume (cells per liter)
Measured: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Change in the power level
Squat Jump (high of the jump measured in centimeters)
Measured: 12 hours before the race, 15 minutes after the race
Change in the lung function
Pulmonary function test by spirometry. The parameters measured are vital capacity (VC), forced vital capacity (FVC), maximal mid-expiratory flow (MEF) and total lung capacity. Outcome data of all these parameters are expressed in liters.
Measured: 12 hours before the race, and 15 minutes after the race
Change in the lung function related to time
Pulmonary function test by spirometry. The parameters measured are forced expiratory volume in 1 second (FEV1) and in 6 seconds (FEV6) and peak expiratory flow (PEF). Outcome data of all these parameters are expressed in liters per second.
Measured: 12 hours before the race, and 15 minutes after the race
Change in the Strength level
Hand grip (pressure in kilograms)
Measured: 12 hours before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Change in the Ventilatory Flow
Ventilatory Flow measurement (liters per minute)
Measured: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Change in the biochemical parameters related to dehydration and kidney injury
Urine test to measure the concentration of sodium and creatinine, as well as urine density
Measured: 60 minutes before the race and 15 minutes after the race
Analysis of tne changes in the Physical activity data
Physical activity measured by wearing accelerometer devices. Physical activity defined as sedentary, light, moderate, vigorous, very vigorous and extremely vigorous. The aim to wear accelerometers devices is to monitor individuals.
Measured: From 9 hours before starting the race to 48 hours after crossing the finish line.
Analysis of the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery
Analysis of different polymorphisms in genomic DNA samples, which were isolated from the saliva sample of each participant.
Measured: 12 hours before the race
Telomere length, genetic marker related to biological aging
Analysis of the telomere length in genomic DNA samples, which were isolated from saliva samples of each participant
Measured: 12 hours before the race
Secondary outcomes (9)
Self-reported questionnaire about social and health status
Personal questionnaire asking for social status. Multiple-choice questions. Participants choose one of the different possible answers. Data is encoded as a factor variable with different levels.
Measured: One month before the race day
Self-reported questionnaire about training habits
Personal questionnaire asking for training habits. Multiple-choice questions. Participants choose one of the different possible answers. Data is encoded as a factor variable with different levels.
Measured: One month before the race day
Self-reported questionnaire about menstrual cycle (only for females)
Personal questionnaire asking for training habits. Open-ended questions. Females answer questions regarding menstrual cycle (duration, dates, regularity, quantity of bleeding, pregnancy history, dysmenorrhea).
Measured: One month before the race day
Assesment of physical condition by cardiopulmonary test
Maximal oxygen consumption (milliliters of oxygen used in one minute per kilogram of body weight)
Measured: One month before the race day
Analysis of body composition (proportion of body fat, fat-free mass and water) per body areas (trunk, arms and legs)
Bioimpedance analysis (percentage of body fat, fat-free mass and water)
Measured: 12 hours before the race, and 15 minutes after the race,
Heart rate
Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during the race
Measured: Through race completion (the time that a runner is performing the 107 kilometers of the race, an average of 25 hours)
Evaluation of effort subjective perception
Borg ratings of perceived exertion (CR10). Scale with ten levels (0-Nothing at all, and 10-Extremely)
Measured: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Evaluation of muscle damage subjective perception per body areas
Evaluation of perceived muscle damage in a 10-level scale. Scale with ten levels (0-Nothing at all, and 10-Extremely)
Measured: 12 hours before the race, 15 minutes after the race, and 48 hours after the race
Change in the body mass
Body mass measurement (weight in kilograms)
Measured: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start25 Feb 2019
- Primary completion4 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Physical ExertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Club Deportivo Marató i Mitja Castelló-Penyagolosa, Fundación Vithas-Nisa, Hospital Vithas-Nisa 9 de Octubre
- Responsible party
- Sponsor
- Investigators
- Carlos Hernando, PhD, Principal investigator, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990259
- Sponsor's protocol ID
- UJI_PTSW001
- Acronym
- PTSW
- Status last verified
- Jun 2019
- First submitted
- 20 May 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to share participant's data
Publications
Cheuvront SN, Carter R, Deruisseau KC, Moffatt RJ. Running performance differences between men and women:an update. Sports Med. 2005;35(12):1017-24. doi: 10.2165/00007256-200535120-00002.
PubMed 16336006Eichenberger E, Knechtle B, Rust CA, Rosemann T, Lepers R. Age and sex interactions in mountain ultramarathon running - the Swiss Alpine Marathon. Open Access J Sports Med. 2012 Jul 31;3:73-80. doi: 10.2147/OAJSM.S33836. eCollection 2012.
PubMed 24198590Gimenez P, Kerherve H, Messonnier LA, Feasson L, Millet GY. Changes in the energy cost of running during a 24-h treadmill exercise. Med Sci Sports Exerc. 2013 Sep;45(9):1807-13. doi: 10.1249/MSS.0b013e318292c0ec.
PubMed 23524515Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.
PubMed 30157271Joyner MJ. Physiological limits to endurance exercise performance: influence of sex. J Physiol. 2017 May 1;595(9):2949-2954. doi: 10.1113/JP272268. Epub 2017 Feb 9.
PubMed 28028816Knechtle B, Knechtle P, Rosemann T, Lepers R. Personal best marathon time and longest training run, not anthropometry, predict performance in recreational 24-hour ultrarunners. J Strength Cond Res. 2011 Aug;25(8):2212-8. doi: 10.1519/JSC.0b013e3181f6b0c7.
PubMed 21642857Knechtle B, Knechtle P, Wirth A, Alexander Rust C, Rosemann T. A faster running speed is associated with a greater body weight loss in 100-km ultra-marathoners. J Sports Sci. 2012;30(11):1131-40. doi: 10.1080/02640414.2012.692479. Epub 2012 Jun 6.
PubMed 22668199Ahmetov I, Kulemin N, Popov D, Naumov V, Akimov E, Bravy Y, Egorova E, Galeeva A, Generozov E, Kostryukova E, Larin A, Mustafina Lj, Ospanova E, Pavlenko A, Starnes L, Zmijewski P, Alexeev D, Vinogradova O, Govorun V. Genome-wide association study identifies three novel genetic markers associated with elite endurance performance. Biol Sport. 2015 Mar;32(1):3-9. doi: 10.5604/20831862.1124568. Epub 2014 Oct 21.
PubMed 25729143Borghini A, Giardini G, Tonacci A, Mastorci F, Mercuri A, Mrakic-Sposta S, Moretti S, Andreassi MG, Pratali L. Chronic and acute effects of endurance training on telomere length. Mutagenesis. 2015 Sep;30(5):711-6. doi: 10.1093/mutage/gev038. Epub 2015 May 22.
PubMed 26001753Martinez-Navarro I, Vicente-Mampel J, Lopez-Grueso R, Collado-Boira E, Recacha-Ponce P, Gomez-Sere T, Hernando C. Muscle Cramping in Ultra-Trail: Dehydration and Electrolyte Depletion versus Muscle Damage. J Strength Cond Res. 2026 Aug 1;40(8):e894-e900. doi: 10.1519/JSC.0000000000005440. Epub 2026 May 22.
PubMed 42172290Martinez-Navarro I, Aparicio I, Priego-Quesada JI, Perez-Soriano P, Collado E, Hernando B, Hernando C. Effects of wearing a full body compression garment during recovery from an ultra-trail race. Eur J Sport Sci. 2021 Jun;21(6):811-818. doi: 10.1080/17461391.2020.1783369. Epub 2020 Jun 30.
PubMed 32538286
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penyagolosa Trail Saludable Women
- ClinicalTrials.gov ID
- NCT03990259
- Acronym / sponsor ID
- PTSW / UJI_PTSW001
- Conditions
- Physical Exertion
- Keywords
- Ultraendurance, Sex differences, Performance, Genetics, Physiological damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Club Deportivo Marató i Mitja Castelló-Penyagolosa, Fundación Vithas-Nisa, Hospital Vithas-Nisa 9 de Octubre
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has as main objective to asses different genetic, biochemical and physiological biomarkers affecting performance and health status in ultraendurance runners according to individual's sex.
Detailed description
Ultraendurance races has been shown to impact on several health-related biomarkers, and therefore they may have detrimental effects on runners' health. In this study, we aim to analyze the impact of running a 107,6 km mountain race in ultraendurance runners splitting our sample by individual's sex.
To do this, baseline measurements of the runners have been collected through stress tests and biochemical analyses of blood and urine samples. Indeed, a saliva sample was collected to isolated a genomic DNA sample of each runner.
During the race anthropometrical, ventilatory and strength data was collected in three different moments and after crossing the finish line. Indeed, after completed the ultraendurance mountain race, blood and urine samples were taken at the finish line, as well as 24h and 48h post-race.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: Running the CSP Mountain RaceThe male individuals of the study population |
| Female | – | Other: Running the CSP Mountain RaceThe female individuals of the study population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 ultraendurance amateur runners, 19 females and 31 males.
Key inclusion criteria (2 listed)
- Healthy adults (>18 years old)
- Volunteers should be finish at least one ultraendurance mountain race (>60km).
Key exclusion criteria (3 listed)
- Having heart disease
- Having kidney disease
- Taking a medication on an ongoing basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Running the CSP Mountain RaceThe runners completed a 107,6 km mountain race | Other | Female, Male |
Primary outcome
Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage
Time frame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Blood concentration of estradiol, testosterone, progesterone, creatinine, troponin, C-reactive protein, hemoglobin, sodium, potassium, chlorine, iron, and ferritin. Concentration of all these parameters is expressed in mass per volume (i.e. nanograms per milliliter)
Change in the biochemical parameters related to muscle damage
Time frame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Blood concentration of lactate dehydrogenase and creatine kinase. The enzyme concentration is expressed in units per volume (enzyme units per milliliter)
Change in the biochemical parameters related to immunological response
Time frame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Blood concentration of erythrocytes, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet volume. The concentration of each cell type is expressed in number of cells per volume (cells per liter)
Change in the power level
Time frame: 12 hours before the race, 15 minutes after the race
Squat Jump (high of the jump measured in centimeters)
Change in the lung function
Time frame: 12 hours before the race, and 15 minutes after the race
Pulmonary function test by spirometry. The parameters measured are vital capacity (VC), forced vital capacity (FVC), maximal mid-expiratory flow (MEF) and total lung capacity. Outcome data of all these parameters are expressed in liters.
Change in the lung function related to time
Time frame: 12 hours before the race, and 15 minutes after the race
Pulmonary function test by spirometry. The parameters measured are forced expiratory volume in 1 second (FEV1) and in 6 seconds (FEV6) and peak expiratory flow (PEF). Outcome data of all these parameters are expressed in liters per second.
Change in the Strength level
Time frame: 12 hours before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Hand grip (pressure in kilograms)
Change in the Ventilatory Flow
Time frame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Ventilatory Flow measurement (liters per minute)
Change in the biochemical parameters related to dehydration and kidney injury
Time frame: 60 minutes before the race and 15 minutes after the race
Urine test to measure the concentration of sodium and creatinine, as well as urine density
Analysis of tne changes in the Physical activity data
Time frame: From 9 hours before starting the race to 48 hours after crossing the finish line.
Physical activity measured by wearing accelerometer devices. Physical activity defined as sedentary, light, moderate, vigorous, very vigorous and extremely vigorous. The aim to wear accelerometers devices is to monitor individuals.
Analysis of the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery
Time frame: 12 hours before the race
Analysis of different polymorphisms in genomic DNA samples, which were isolated from the saliva sample of each participant.
Telomere length, genetic marker related to biological aging
Time frame: 12 hours before the race
Analysis of the telomere length in genomic DNA samples, which were isolated from saliva samples of each participant
9 secondary outcomes
Self-reported questionnaire about social and health status
Time frame: One month before the race day
Self-reported questionnaire about training habits
Time frame: One month before the race day
Self-reported questionnaire about menstrual cycle (only for females)
Time frame: One month before the race day
Assesment of physical condition by cardiopulmonary test
Time frame: One month before the race day
Analysis of body composition (proportion of body fat, fat-free mass and water) per body areas (trunk, arms and legs)
Time frame: 12 hours before the race, and 15 minutes after the race,
Heart rate
Time frame: Through race completion (the time that a runner is performing the 107 kilometers of the race, an average of 25 hours)
Evaluation of effort subjective perception
Time frame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Evaluation of muscle damage subjective perception per body areas
Time frame: 12 hours before the race, 15 minutes after the race, and 48 hours after the race
Change in the body mass
Time frame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Background: PubMed 16336006Cheuvront SN, Carter R, Deruisseau KC, Moffatt RJ. Running performance differences between men and women:an update. Sports Med. 2005;35(12):1017-24. doi: 10.2165/00007256-200535120-00002.
- Background: PubMed 24198590Eichenberger E, Knechtle B, Rust CA, Rosemann T, Lepers R. Age and sex interactions in mountain ultramarathon running - the Swiss Alpine Marathon. Open Access J Sports Med. 2012 Jul 31;3:73-80. doi: 10.2147/OAJSM.S33836. eCollection 2012.
- Background: PubMed 23524515Gimenez P, Kerherve H, Messonnier LA, Feasson L, Millet GY. Changes in the energy cost of running during a 24-h treadmill exercise. Med Sci Sports Exerc. 2013 Sep;45(9):1807-13. doi: 10.1249/MSS.0b013e318292c0ec.
- Background: PubMed 30157271Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.
- Background: PubMed 28028816Joyner MJ. Physiological limits to endurance exercise performance: influence of sex. J Physiol. 2017 May 1;595(9):2949-2954. doi: 10.1113/JP272268. Epub 2017 Feb 9.
- Background: PubMed 21642857Knechtle B, Knechtle P, Rosemann T, Lepers R. Personal best marathon time and longest training run, not anthropometry, predict performance in recreational 24-hour ultrarunners. J Strength Cond Res. 2011 Aug;25(8):2212-8. doi: 10.1519/JSC.0b013e3181f6b0c7.
- Background: PubMed 22668199Knechtle B, Knechtle P, Wirth A, Alexander Rust C, Rosemann T. A faster running speed is associated with a greater body weight loss in 100-km ultra-marathoners. J Sports Sci. 2012;30(11):1131-40. doi: 10.1080/02640414.2012.692479. Epub 2012 Jun 6.
- Background: PubMed 25729143Ahmetov I, Kulemin N, Popov D, Naumov V, Akimov E, Bravy Y, Egorova E, Galeeva A, Generozov E, Kostryukova E, Larin A, Mustafina Lj, Ospanova E, Pavlenko A, Starnes L, Zmijewski P, Alexeev D, Vinogradova O, Govorun V. Genome-wide association study identifies three novel genetic markers associated with elite endurance performance. Biol Sport. 2015 Mar;32(1):3-9. doi: 10.5604/20831862.1124568. Epub 2014 Oct 21.
- Background: PubMed 26001753Borghini A, Giardini G, Tonacci A, Mastorci F, Mercuri A, Mrakic-Sposta S, Moretti S, Andreassi MG, Pratali L. Chronic and acute effects of endurance training on telomere length. Mutagenesis. 2015 Sep;30(5):711-6. doi: 10.1093/mutage/gev038. Epub 2015 May 22.
- Derived from this study: PubMed 42172290Martinez-Navarro I, Vicente-Mampel J, Lopez-Grueso R, Collado-Boira E, Recacha-Ponce P, Gomez-Sere T, Hernando C. Muscle Cramping in Ultra-Trail: Dehydration and Electrolyte Depletion versus Muscle Damage. J Strength Cond Res. 2026 Aug 1;40(8):e894-e900. doi: 10.1519/JSC.0000000000005440. Epub 2026 May 22.
- Derived from this study: PubMed 32538286Martinez-Navarro I, Aparicio I, Priego-Quesada JI, Perez-Soriano P, Collado E, Hernando B, Hernando C. Effects of wearing a full body compression garment during recovery from an ultra-trail race. Eur J Sport Sci. 2021 Jun;21(6):811-818. doi: 10.1080/17461391.2020.1783369. Epub 2020 Jun 30.
- Individual participant dataSharing planned: No. It is not planned to share participant's data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Hernando, PhD principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Exertion, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage (time frame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990259, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.