Penyagolosa Trail Saludable Women (PTSW)

June 17, 2019 updated by: Universitat Jaume I
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Castellón De La Plana, Spain, 12071
        • Universitat Jaume I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50 ultraendurance amateur runners, 19 females and 31 males.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male
The male individuals of the study population
Other: Running the CSP Mountain Race
The runners completed a 107,6 km mountain race
Female
The female individuals of the study population
Other: Running the CSP Mountain Race
The runners completed a 107,6 km mountain race

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
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
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)
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
Time Frame: 12 hours before the race, 15 minutes after the race
Squat Jump (high of the jump measured in centimeters)
12 hours before the race, 15 minutes after the race
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.
12 hours before the race, and 15 minutes after the race
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.
12 hours before the race, and 15 minutes after the race
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)
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
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)
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
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
60 minutes before the race and 15 minutes after the race
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.
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
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 hours before the race
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
12 hours before the race

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month before the race day
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.
One month before the race day
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).
One month before the race day
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)
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)
Time Frame: 12 hours before the race, and 15 minutes after the race,
Bioimpedance analysis (percentage of body fat, fat-free mass and water)
12 hours before the race, and 15 minutes after the race,
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
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
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)
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
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)
12 hours before the race, 15 minutes after the race, and 48 hours after the race
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)
60 minutes before the race, in three moments during the race (after running 33km, 65km and 94 km), and 15 minutes after the race,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Collaborators

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

Investigators

  • Principal Investigator: Carlos Hernando, PhD, Universitat Jaume I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2019

Primary Completion (ACTUAL)

April 4, 2019

Study Completion (ACTUAL)

April 16, 2019

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (ACTUAL)

June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UJI_PTSW001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not planned to share participant's data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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