Penyagolosa Trail Saludable Women
PTSW
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2019
CompletedFirst Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedJune 18, 2019
June 1, 2019
1 month
May 20, 2019
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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
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
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
Change in the power level
Squat Jump (high of the jump measured in centimeters)
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.
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.
12 hours before the race, and 15 minutes after the race
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
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
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
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.
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
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 Outcomes (9)
Self-reported questionnaire about social and health status
One month before the race day
Self-reported questionnaire about training habits
One month before the race day
Self-reported questionnaire about menstrual cycle (only for females)
One month before the race day
Assesment of physical condition by cardiopulmonary test
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)
12 hours before the race, and 15 minutes after the race,
- +4 more secondary outcomes
Study Arms (2)
Male
The male individuals of the study population
Female
The female individuals of the study population
Interventions
Eligibility Criteria
50 ultraendurance amateur runners, 19 females and 31 males.
You may qualify if:
- Healthy adults (\>18 years old)
- Volunteers should be finish at least one ultraendurance mountain race (\>60km).
You may not qualify if:
- Having heart disease
- Having kidney disease
- Taking a medication on an ongoing basis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitat Jaume Ilead
- Club Deportivo Marató i Mitja Castelló-Penyagolosacollaborator
- Fundación Vithas-Nisacollaborator
- Hospital Vithas-Nisa 9 de Octubrecollaborator
Study Sites (1)
Universitat Jaume I
Castellon, 12071, Spain
Related Publications (10)
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.
PMID: 16336006BACKGROUNDEichenberger 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.
PMID: 24198590BACKGROUNDGimenez 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.
PMID: 23524515BACKGROUNDHernando 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.
PMID: 30157271BACKGROUNDJoyner 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.
PMID: 28028816BACKGROUNDKnechtle 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.
PMID: 21642857BACKGROUNDKnechtle 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.
PMID: 22668199BACKGROUNDAhmetov 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.
PMID: 25729143BACKGROUNDBorghini 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.
PMID: 26001753BACKGROUNDMartinez-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.
PMID: 32538286DERIVED
Biospecimen
The genomic DNA was isolated from a saliva sample
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Hernando, PhD
Universitat Jaume I
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
June 18, 2019
Study Start
February 25, 2019
Primary Completion
April 4, 2019
Study Completion
April 16, 2019
Last Updated
June 18, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
It is not planned to share participant's data