MedPath

Penyagolosa Trail Saludable Women

Completed
Conditions
Physical Exertion
Interventions
Other: Running the CSP Mountain Race
Registration Number
NCT03990259
Lead Sponsor
Universitat Jaume I
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
FemaleRunning the CSP Mountain RaceThe female individuals of the study population
MaleRunning the CSP Mountain RaceThe male individuals of the study population
Primary Outcome Measures
NameTimeMethod
Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage12 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 power level12 hours before the race, 15 minutes after the race

Squat Jump (high of the jump measured in centimeters)

Change in the Ventilatory Flow60 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)

Analysis of tne changes in the Physical activity dataFrom 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.

Change in the lung function12 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 biochemical parameters related to immunological response12 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 biochemical parameters related to muscle damage12 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 Strength level12 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 lung function related to time12 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 biochemical parameters related to dehydration and kidney injury60 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 the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery12 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 aging12 hours before the race

Analysis of the telomere length in genomic DNA samples, which were isolated from saliva samples of each participant

Secondary Outcome Measures
NameTimeMethod
Self-reported questionnaire about training habitsOne month before the race day

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.

Self-reported questionnaire about menstrual cycle (only for females)One month before the race day

Personal questionnaire asking for training habits. Open-ended questions. Females answer questions regarding menstrual cycle (duration, dates, regularity, quantity of bleeding, pregnancy history, dysmenorrhea).

Assesment of physical condition by cardiopulmonary testOne month before the race day

Maximal oxygen consumption (milliliters of oxygen used in one minute per kilogram of body weight)

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,

Bioimpedance analysis (percentage of body fat, fat-free mass and water)

Evaluation of effort subjective perception60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race

Borg ratings of perceived exertion (CR10). Scale with ten levels (0-Nothing at all, and 10-Extremely)

Heart rateThrough race completion (the time that a runner is performing the 107 kilometers of the race, an average of 25 hours)

Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during the race

Self-reported questionnaire about social and health statusOne month before the race day

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.

Evaluation of muscle damage subjective perception per body areas12 hours before the race, 15 minutes after the race, and 48 hours after the race

Evaluation of perceived muscle damage in a 10-level scale. Scale with ten levels (0-Nothing at all, and 10-Extremely)

Change in the body mass60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,

Body mass measurement (weight in kilograms)

Trial Locations

Locations (1)

Universitat Jaume I

🇪🇸

Castellón De La Plana, Spain

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