Penyagolosa Trail Saludable Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Penyagolosa Trail Saludable Women

Conditions
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Physical Exertion

Intervention / Treatment
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* Other: Running the CSP Mountain Race


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male<br>The male individuals of the study population | Other: Running the CSP Mountain Race<br>* The runners completed a 107,6 km mountain race<br>|
| Female<br>The female individuals of the study population | Other: Running the CSP Mountain Race<br>* The runners completed a 107,6 km mountain race<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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, | 
| 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) | 
| 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 | 
| 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 | 
| 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, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultraendurance, Sex differences, Performance, Genetics, Physiological damage