- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06297317
Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event (Trailstiff)
March 24, 2025 updated by: University Hospital, Caen
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen, France, 14000
- CHU Caen Normandie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
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/)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Achille tendon cross sectional area
Time Frame: 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.
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Mid-portion Achille tendon cross sectional area was measured (in mm²) using B mode ultrasound imaging
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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.
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Medial gastrocnemius thickness
Time Frame: 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.
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Medial gastrocnemius thickness was measured at the inferior third of muscle llength (in mm) using B mode ultrasound imaging
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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.
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Medial gastrocnemius pennation angle
Time Frame: 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.
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Medial gastrocnemius pennation angle was measured at the inferior third of muscle llength (in °) using B mode ultrasound imaging
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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.
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Medial gastrocnemius fascicle length
Time Frame: 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.
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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
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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.
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Medial gastrocnemius muscle length
Time Frame: 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.
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Medial gastrocnemius muscle length was measured using an extended-field-of-view (EFOV) ultrasound imaging
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Finisher status
Time Frame: One time point, after the race
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Participants were classifioed as "Finishers" or "Did not finish" whether they completed the 156-km race, or not
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One time point, after the race
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Average speed
Time Frame: 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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Average speed was calculated using the time per lap and distance for each lap
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2021
Primary Completion (Actual)
November 13, 2021
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 28, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Estimated)
March 26, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Trailstiff
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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