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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06297317
Other study ID # Trailstiff
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2021
Est. completion date February 1, 2024

Study information

Verified date February 2024
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date February 1, 2024
Est. primary completion date November 13, 2021
Accepts healthy volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Ultrasound measurement of triceps surae muscle-tendon architecture
The resting plantar-flexors MTU architecture assessment was performed using a conventional B-mode and extended-field-of-view (EFOV) ultrasound imaging. Achille tendon cross-sectionnal area, Medial gastrocnemius thickness, pennation angle, fascicle length and muscle length were collected on the dominant lower limb.

Locations

Country Name City State
France CHU Caen Normandie Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Achille tendon cross sectional area Mid-portion Achille tendon cross sectional area was measured (in mm²) using B mode ultrasound imaging 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.
Primary Medial gastrocnemius thickness Medial gastrocnemius thickness was measured at the inferior third of muscle llength (in mm) using B mode ultrasound imaging 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.
Primary Medial gastrocnemius pennation angle Medial gastrocnemius pennation angle was measured at the inferior third of muscle llength (in °) using B mode ultrasound imaging 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.
Primary Medial gastrocnemius fascicle length Medial gastrocnemius fascicle length was calculated under the assumption of linearity as Fascicle Lnegth = Muscle Thickness / sin (Pennation angle) measured at the inferior third of muscle length (calculated in mm) using B mode ultrasound imaging 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.
Primary Medial gastrocnemius muscle length Medial gastrocnemius muscle length was measured using an extended-field-of-view (EFOV) ultrasound imaging 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 Finisher status Participants were classifioed as "Finishers" or "Did not finish" whether they completed the 156-km race, or not One time point, after the race
Secondary Average speed Average speed was calculated using the time per lap and distance for each lap 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.
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