Penyagolosa Trail Saludable 2025

NCT06969898 | Completed DMC

• 1 other identifier: PTS2025 CEISH/103/2024
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The research team leading this project frames it within the objective of advancing knowledge about what happens to this group of athletes who participate in Ultratrail events, with the particularity of studying them during the race itself. To achieve this, the study aims to address four key perspectives. First, it seeks to understand the training habits of male and female Ultratrail runners. Second, it aims to assess their physical condition and analyze how uphill and downhill segments affect their muscle performance, running efficiency, and strength levels. Third, it investigates the key factors that determine the prediction of race performance for both male and female runners. Finally, the fourth objective is to examine sex differences as a conditioning factor in physiological processes.

Conditions

Physical Exercise

Keywords

Ultramarathon; biomarkers; Muscle damage; recovery; runners; ultrasound

Outcome Measures

Primary Outcomes (5)

• Physiological Parameters

  Blood Analysis: Blood samples will be analyzed for the following parameters: * Number of red cells in a volume of blood in µL. (number of red cells x10\^6 / µL ) * Creatine Kinase (CK) in International Units in a volume of blood in litres. (U/L) * Lactate Dehydrogenase (LDH) in International Units in a volume of blood in litres. (U/L) * C-reactive Protein (CRP) in milligrams in a volume of blood in litres. (mg/L) * Sodium (Na) in millimoles in a volume of blood in litres (mmol/L) * Potassium (K) in millimoles in a volume of blood in litres (mmol/L) * Interleukin 6 (IL-6) in picograms in a volume of blood (pg/dL) Blood Sample Collection: Blood samples will be collected twice during the second laboratory session-once before starting the treadmill test (negative 15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additional blood samples will be taken at baseline before the race, at the finish line, 24 hours post-race, and 48 hours post-race.

  From the enrollment to 48 hours post-race (12 weeks). Baseline (4 weeks after enrollment), post-1-2-3 and 4, 11th week (11 weeks after baseline)

• Muscle Damage

  The knee extensors will be measured using ultrasound. Muscle fibre thickness of Rectus femoris and Vastus lateralis will be measured in cm. Pennation angle of muscle fibre of Rectus femoris and Vastus lateralis will be measured in degrees. The ankle extensors will be measured using ultrasound. Muscle fibre thickness of Medial gastrocnemius will be measured in cm. Pennation angle of muscle fibre of Medial gastrocnemius will be measured in degrees. Assessments will be conducted twice during the second laboratory session: once before starting the treadmill test (-15% incline for 5 km at VT1 speed) and again 30 minutes after completing the test. Additionally, measurements will be taken at baseline before the race start and at the finish line

  From the enrolment to 48 hours post-race (12 weeks). First measured of knee and ankle extensors will be in 5th week (4 weeks after baseline). Second, and third measured of knee and ankle extensors will be in 11th week (10 weeks after baseline).

• Strength levels

  Measurements: * Squat Jump (SJ): Jump height in centimetres will be measured during a vertical jump performed from a squat position without a countermovement. * Reactive Strength Index (RSI): The subject performs a sequence of 10 consecutive jumps, during which flight time (in milliseconds) and ground contact time (in milliseconds) are measured. These two variables are used to calculate the Reactive Strength Index (RSI), defined as the ratio of flight time to contact time (flight time in milliseconds / contact time in milliseconds). * Maximal Isometric Strength (MIS): The isometric strength of the knee and ankle extensors will be measured in Newtons (N). Collection of Measurements: • Squat Jump will be evaluated during the first laboratory session (first week), before and after cardiopulmonary test (two jumps per attempt). • Reactive Jump will be assessed during the first laboratory session (first week), before and after the 5 km at VT1 speed treadmill test (-15% incline)

  First SJ measured (first week), second SJ at day before the race (11th week) third SJ at the end of the race (11th week). RSI will be measured at the first laboratory session (1st week). MIS will be measured at the second laboratory session (5th week)

• Physical activity data

  Accelerometry: Physical activity (counts per minute, CPM) will be measured using an accelerometer placed on the non-dominant wrist. Activity levels will be classified into six categories: sedentary, light, moderate, vigorous, very vigorous, and extremely vigorous. Collection of Measurements: * Accelerometry will be recorded during laboratory assessments. * An accelerometer will be placed on the participant the day before the race to continuously collect physical activity data until 48 hours post-race.

  Laboratory 4 weeks before the race. During the race 96 hours (from the day before the race to 48hours post-race)

• Physiological Parameters

  Urine Samples: Urinary density (mg/dL) Urine samples will be collected at baseline before the race and at the finish line, with measurements of urinary density (Units: mg/dL).

  At the start line of the race (11th week) and at the end of the race (11th week)

Secondary Outcomes (5)

• Body Composition & Anthropometry

  Baseline (1st week)

• Physical Condition

  Baseline (1st week) and post baseline (5th week)

• Muscle Oxygenation Measurement

  Baseline (Day 1) and post baseline (4 weeks after baseline)

• Running Power Measurement

  Baseline (Day 1) and post baseline (4 weeks after baseline)

• Weight

  The start line of the race (11th week), during the intervention three times during the race (in km 32, in km 62 and in km 81) and at the end of the race (11th week)

Study Arms (1)

Single Ultramarathon runners

All participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours.

Other: Single Ultramarathon runners

Interventions

Single Ultramarathon runners OTHER

All participants underwent the same protocol: two laboratory assessments, a 106 km race, and post-race physiological parameter evaluations at 24 hours and 48 hours.

Single Ultramarathon runners

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Ultra-trail runners that will participate in the CSP2025 race (Castellón, Spain; 2025/04/11-12)

You may qualify if:

• Adults healthy with 18-60 years
• Must have completed at least two races of 65 km or longer.
• Must be registered as a participant in the CSP 2025 race

You may not qualify if:

• Having heart disease
• Having kidney disease
• Taking a medication on an ongoing basis

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Jaume I Univesity

Castellon, Castellón, 12071, Spain

Location

Related Publications (5)

• Hernando C, Hernando C, Collado EJ, Panizo N, Martinez-Navarro I, Hernando B. Establishing cut-points for physical activity classification using triaxial accelerometer in middle-aged recreational marathoners. PLoS One. 2018 Aug 29;13(8):e0202815. doi: 10.1371/journal.pone.0202815. eCollection 2018.

  PMID: 30157271 BACKGROUND

• Guerrero C, Collado-Boira E, Martinez-Navarro I, Hernando B, Hernando C, Balino P, Muriach M. Impact of Plasma Oxidative Stress Markers on Post-race Recovery in Ultramarathon Runners: A Sex and Age Perspective Overview. Antioxidants (Basel). 2021 Feb 27;10(3):355. doi: 10.3390/antiox10030355.

  PMID: 33673404 BACKGROUND

• Granero-Gallegos A, Gonzalez-Quilez A, Plews D, Carrasco-Poyatos M. HRV-Based Training for Improving VO2max in Endurance Athletes. A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2020 Oct 30;17(21):7999. doi: 10.3390/ijerph17217999.

  PMID: 33143175 BACKGROUND

• Baygutalp F, Buzdagli Y, Ozan M, Koz M, Kilic Baygutalp N, Atasever G. Impacts of different intensities of exercise on inflammation and hypoxia markers in low altitude. BMC Sports Sci Med Rehabil. 2021 Nov 22;13(1):145. doi: 10.1186/s13102-021-00375-0.

  PMID: 34809670 BACKGROUND

• Baird MF, Graham SM, Baker JS, Bickerstaff GF. Creatine-kinase- and exercise-related muscle damage implications for muscle performance and recovery. J Nutr Metab. 2012;2012:960363. doi: 10.1155/2012/960363. Epub 2012 Jan 11.

  PMID: 22288008 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Carlos Hernando

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: May 14, 2025
• Study Start: January 1, 2025
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

ES (1)