NCT06297317

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 26, 2025

Status Verified

February 1, 2024

Enrollment Period

2 days

First QC Date

February 19, 2024

Last Update Submit

March 24, 2025

Conditions

Achilles TendinopathyCalf InjurySport InjuryLower Limb Injury

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (2)

  • Finisher status

    One time point, after the race

  • Average speed

    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.

Study Arms (1)

Experienced long-distance trail runners

All the participants of the First 'Trail Scientifique de Clécy 2021". This was a multidisciplinary protocol to investigate the mechanisms that contribute to performance during an ultradistance trail race (156-km)

Diagnostic Test: Ultrasound measurement of triceps surae muscle-tendon architecture

Interventions

Ultrasound measurement of triceps surae muscle-tendon architectureDIAGNOSTIC_TEST

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.

Experienced long-distance trail runners

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the participants engaged in the First Trail Scientifique de Clécy 2021(https://pubmed.ncbi.nlm.nih.gov/35704381/)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

Related 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.

    PMID: 35704381BACKGROUND

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 7, 2024

Study Start

November 11, 2021

Primary Completion

November 13, 2021

Study Completion

February 1, 2024

Last Updated

March 26, 2025

Record last verified: 2024-02

Locations

FR(1)