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Completed

NCT Number: NCT03990259

Penyagolosa Trail Saludable Women

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.

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Key information

Conditions

Physical Exertion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitat Jaume I

Castellon, 12071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Running the CSP Mountain Race

Other

The runners completed a 107,6 km mountain race

Primary outcomes

  1. Change in the biochemical parameters related to kidney injury, dehydration, inflammation, and cardiac damage

    Time frame: 12 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)

  2. Change in the biochemical parameters related to muscle damage

    Time frame: 12 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)

  3. Change in the biochemical parameters related to immunological response

    Time frame: 12 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)

  4. Change in the power level

    Time frame: 12 hours before the race, 15 minutes after the race

    Squat Jump (high of the jump measured in centimeters)

  5. Change in the lung function

    Time frame: 12 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.

  6. Change in the lung function related to time

    Time frame: 12 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.

  7. Change in the Strength level

    Time frame: 12 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)

  8. Change in the Ventilatory Flow

    Time frame: 60 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)

  9. Change in the biochemical parameters related to dehydration and kidney injury

    Time frame: 60 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

  10. Analysis of tne changes in the Physical activity data

    Time frame: From 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.

  11. Analysis of the presence or absence of genetic markers related to endurance performance and ability to muscle damage recovery

    Time frame: 12 hours before the race

    Analysis of different polymorphisms in genomic DNA samples, which were isolated from the saliva sample of each participant.

  12. Telomere length, genetic marker related to biological aging

    Time frame: 12 hours before the race

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

Secondary outcomes

  1. Self-reported questionnaire about social and health status

    Time frame: One 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.

  2. Self-reported questionnaire about training habits

    Time frame: One 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.

  3. Self-reported questionnaire about menstrual cycle (only for females)

    Time frame: 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).

  4. Assesment of physical condition by cardiopulmonary test

    Time frame: One month before the race day

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

  5. Analysis of body composition (proportion of body fat, fat-free mass and water) per body areas (trunk, arms and legs)

    Time frame: 12 hours before the race, and 15 minutes after the race,

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

  6. Heart rate

    Time frame: Through 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

  7. Evaluation of effort subjective perception

    Time frame: 60 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)

  8. Evaluation of muscle damage subjective perception per body areas

    Time frame: 12 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)

  9. Change in the body mass

    Time frame: 60 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)

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Collaborators

  • Club Deportivo Marató i Mitja Castelló-Penyagolosa
  • Fundación Vithas-Nisa
  • Hospital Vithas-Nisa 9 de Octubre

Registry information

Acronym: PTSW

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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