Penyagolosa Trail Saludable Women

Physical Exertion Clinical Trial

— PTSW  

Official title:

Penyagolosa Trail Saludable Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990259
• Other study ID #: UJI_PTSW001
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: April 16, 2019

Study information

• Verified date: June 2019
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 16, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adults (>18 years old)

• Volunteers should be finish at least one ultraendurance mountain race (>60km).

Exclusion Criteria:

• Having heart disease

• Having kidney disease

• Taking a medication on an ongoing basis

Related Conditions & MeSH terms

• Physical Exertion

Intervention

Other:
• Running the CSP Mountain Race
The runners completed a 107,6 km mountain race

Locations

Country	Name	City	State
Spain	Universitat Jaume I	Castellón De La Plana

Sponsors (4)

Lead Sponsor	Collaborator
Universitat Jaume I	Club Deportivo Marató i Mitja Castelló-Penyagolosa, Fundación Vithas-Nisa, Hospital Vithas-Nisa 9 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Ahmetov 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. — View Citation

Borghini 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. Erratum in: Mutagenesis. 2016 Mar;31(2):231. — View Citation

Cheuvront SN, Carter R, Deruisseau KC, Moffatt RJ. Running performance differences between men and women:an update. Sports Med. 2005;35(12):1017-24. Review. — View Citation

Eichenberger E, Knechtle B, Rüst 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. — View Citation

Gimenez P, Kerhervé H, Messonnier LA, Féasson 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. — View Citation

Hernando 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. — View Citation

Joyner 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. Review. — View Citation

Knechtle 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. — View Citation

Knechtle B, Knechtle P, Wirth A, Alexander Rüst 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Primary	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)	12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Primary	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)	12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
Primary	Change in the power level	Squat Jump (high of the jump measured in centimeters)	12 hours before the race, 15 minutes after the race
Primary	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.	12 hours before the race, and 15 minutes after the race
Primary	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.	12 hours before the race, and 15 minutes after the race
Primary	Change in the Strength level	Hand grip (pressure in kilograms)	12 hours before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Primary	Change in the Ventilatory Flow	Ventilatory Flow measurement (liters per minute)	60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Primary	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	60 minutes before the race and 15 minutes after the race
Primary	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.	From 9 hours before starting the race to 48 hours after crossing the finish line.
Primary	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.	12 hours before the race
Primary	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	12 hours before the race
Secondary	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.	One month before the race day
Secondary	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.	One month before the race day
Secondary	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).	One month before the race day
Secondary	Assesment of physical condition by cardiopulmonary test	Maximal oxygen consumption (milliliters of oxygen used in one minute per kilogram of body weight)	One month before the race day
Secondary	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)	12 hours before the race, and 15 minutes after the race,
Secondary	Heart rate	Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during the race	Through race completion (the time that a runner is performing the 107 kilometers of the race, an average of 25 hours)
Secondary	Evaluation of effort subjective perception	Borg ratings of perceived exertion (CR10). Scale with ten levels (0-Nothing at all, and 10-Extremely)	60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
Secondary	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)	12 hours before the race, 15 minutes after the race, and 48 hours after the race
Secondary	Change in the body mass	Body mass measurement (weight in kilograms)	60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,