Clinical trial NCT06969898: Penyagolosa Trail Saludable 2025
Official title: Penyagolosa Trail Saludable 2025
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Physical Exercise
Keywords: Ultramarathon
biomarkers
Muscle damage
recovery
runners
ultrasound
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ultra-trail runners that will participate in the CSP2025 race (Castellón, Spain; 2025/04/11-12)

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.

Detailed description: There is a category of sporting events held in natural environments over very long distances, classified as Ultratrail races. These races have grown in popularity, attracting an increasing number of participants.

Such races induce states of exhaustion and fatigue, with performance being influenced by numerous factors (environmental conditions, terrain, course profile, etc.), in addition to the athlete's individual characteristics. Scientific interest in these events has surged, and the research community is closely monitoring the health status of participants and their involvement in such races. The aim is to identify the factors influencing performance in a 106 km race (Castelló-Penyagolosa of Penyagolosa Trails) and to assess the physiological impact of participating in this type of endurance event.

To conduct this study, data collection took place before the race, during the race, and within the 48-hour post-race recovery phase.

Before the race, two laboratory sessions were conducted to analyze the athlete's physical condition and assess muscle damage under conditions of both uphill and downhill running. Blood samples were taken before and after these tests.

On race day, measurements included strength loss, weight, dehydration levels, race nutrition, and the evolution of physiological parameters through blood and urine analyses conducted before and after the race.

Finally, blood samples were collected at 24-hours and 48-hours post-race to track the progression of physiological parameters during the recovery phase.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Physiological Parameters
timeFrame: 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)
measure: Muscle Damage
timeFrame: 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).
measure: Strength levels
timeFrame: 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)
measure: Physical activity data
timeFrame: Laboratory 4 weeks before the race. During the race 96 hours (from the day before the race to 48hours post-race)
measure: Physiological Parameters
timeFrame: At the start line of the race (11th week) and at the end of the race (11th week)
Secondary outcomes:
measure: Body Composition & Anthropometry
timeFrame: Baseline (1st week)
measure: Physical Condition
timeFrame: Baseline (1st week) and post baseline (5th week)
measure: Muscle Oxygenation Measurement
timeFrame: Baseline (Day 1) and post baseline (4 weeks after baseline)
measure: Running Power Measurement
timeFrame: Baseline (Day 1) and post baseline (4 weeks after baseline)
measure: Weight
timeFrame: 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)
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Jaume I Univesity
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: Carlos Hernando
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.