Clinical trial NCT06297317: Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event
Official title: Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendinopathy
Calf Injury
Sport Injury
Lower Limb Injury
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the participants engaged in the First Trail Scientifique de Clécy 2021(https://pubmed.ncbi.nlm.nih.gov/35704381/)

Brief summary: This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12).


Eligibility criteria: Inclusion criteria

* Experienced runners voluntarily participating in the Trail Scientifique de Clécy (156 km/6000 D+)
* Participants who had already completed 2 ultratrail races (+160 km and -160 km), at least one of them in the past 24 months; the participants had to justify their events and rankings
* Participants affiliated with a social security system or those who were a beneficiary of such a system
* Participants who could speak and read the French language
* Participants with the ability to physically participate in the ultraendurance race
* Participants with the ability to provide written consent for participation in the study

Exclusion criteria

* Participants with cardiac or extracardiac contraindications to intense physical activity
* Participants who had run a mountain ultramarathon (160 km) after September 2, 2021
* Pregnant or breastfeeding women
* Minor participants
* Participants included in another biomedical research protocol during this study
* Participants with recent muscular and orthopedic injuries, limiting running for \<15 days
* Participants with a history of ankle joint surgery (eg, arthrodesis)
* Participants with a history of foot or ankle surgery
* Participants with lower-limb pathology or trauma

Primary outcomes:
measure: Achille tendon cross sectional area
timeFrame: Five time points: (1) at baseline, the day before the 156-km race, (2) during the race, at 52-km, (3) during the race, at 104-km, (4) immediately after the race, at 156-km and (5) at 12-hours after arrival.
measure: Medial gastrocnemius thickness
timeFrame: Five time points: (1) at baseline, the day before the 156-km race, (2) during the race, at 52-km, (3) during the race, at 104-km, (4) immediately after the race, at 156-km and (5) at 12-hours after arrival.
measure: Medial gastrocnemius pennation angle
timeFrame: Five time points: (1) at baseline, the day before the 156-km race, (2) during the race, at 52-km, (3) during the race, at 104-km, (4) immediately after the race, at 156-km and (5) at 12-hours after arrival.
measure: Medial gastrocnemius fascicle length
timeFrame: Five time points: (1) at baseline, the day before the 156-km race, (2) during the race, at 52-km, (3) during the race, at 104-km, (4) immediately after the race, at 156-km and (5) at 12-hours after arrival.
measure: Medial gastrocnemius muscle length
timeFrame: Five time points: (1) at baseline, the day before the 156-km race, (2) during the race, at 52-km, (3) during the race, at 104-km, (4) immediately after the race, at 156-km and (5) at 12-hours after arrival.
Secondary outcomes:
measure: Finisher status
timeFrame: One time point, after the race
measure: Average speed
timeFrame: Four time point (1) during the race, at 52-km, (2) during the race, at 104-km, (3) during the race, at 156-km and (4) for the whole race.
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References:
citation: Mauvieux B, Hingrand C, Drigny J, Hodzic A, Baron P, Hurdiel R, Jouffroy R, Vauthier JC, Pessiglione M, Wiehler A, Degache F, Pavailler S, Heyman E, Plard M, Noirez P, Dubois B, Esculier JF, Nguyen AP, Van Cant J, Roy Baillargeon O, Pairot de Fontenay B, Delaunay PL, Besnard S. Study of the Kinetics of the Determinants of Performance During a Mountain Ultramarathon: Multidisciplinary Protocol of the First Trail Scientifique de Clecy 2021. JMIR Res Protoc. 2022 Jun 15;11(6):e38027. doi: 10.2196/38027.