Clinical trial NCT03990259: Penyagolosa Trail Saludable Women
Official title: Penyagolosa Trail Saludable Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Exertion
Keywords: Ultraendurance
Sex differences
Performance
Genetics
Physiological damage
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Club Deportivo Marató i Mitja Castelló-Penyagolosa
name: Fundación Vithas-Nisa
name: Hospital Vithas-Nisa 9 de Octubre
First posted: 2019-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 50 ultraendurance amateur runners, 19 females and 31 males.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage
timeFrame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
measure: Change in the biochemical parameters related to muscle damage
timeFrame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
measure: Change in the biochemical parameters related to immunological response
timeFrame: 12 hours before the race, 15 minutes after the race, 24 hours after the race and 48 hours after the race
measure: Change in the power level
timeFrame: 12 hours before the race, 15 minutes after the race
measure: Change in the lung function
timeFrame: 12 hours before the race, and 15 minutes after the race
measure: Change in the lung function related to time
timeFrame: 12 hours before the race, and 15 minutes after the race
measure: Change in the Strength level
timeFrame: 12 hours before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
measure: Change in the Ventilatory Flow
timeFrame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
measure: Change in the biochemical parameters related to dehydration and kidney injury
timeFrame: 60 minutes before the race and 15 minutes after the race
measure: Analysis of tne changes in the Physical activity data
timeFrame: From 9 hours before starting the race to 48 hours after crossing the finish line.
measure: Analysis of the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery
timeFrame: 12 hours before the race
measure: Telomere length, genetic marker related to biological aging
timeFrame: 12 hours before the race
Secondary outcomes:
measure: Self-reported questionnaire about social and health status
timeFrame: One month before the race day
measure: Self-reported questionnaire about training habits
timeFrame: One month before the race day
measure: Self-reported questionnaire about menstrual cycle (only for females)
timeFrame: One month before the race day
measure: Assesment of physical condition by cardiopulmonary test
timeFrame: One month before the race day
measure: Analysis of body composition (proportion of body fat, fat-free mass and water) per body areas (trunk, arms and legs)
timeFrame: 12 hours before the race, and 15 minutes after the race,
measure: Heart rate
timeFrame: Through race completion (the time that a runner is performing the 107 kilometers of the race, an average of 25 hours)
measure: Evaluation of effort subjective perception
timeFrame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race
measure: Evaluation of muscle damage subjective perception per body areas
timeFrame: 12 hours before the race, 15 minutes after the race, and 48 hours after the race
measure: Change in the body mass
timeFrame: 60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
Study officials:
affiliation: Universitat Jaume I
name: Carlos Hernando, PhD
role: PRINCIPAL_INVESTIGATOR
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