Achilles TendinopathyTrailstiffNCT06297317
Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event
An observational study of Achilles Tendinopathy and Calf Injury, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Achilles Tendinopathy, Calf Injury, Sport Injury
- What is being tested?
- Ultrasound measurement of triceps surae muscle-tendon architecture
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Adult, Older adult
Study population: All the participants engaged in the First Trail Scientifique de Clécy 2021(https://pubmed.ncbi.nlm.nih.gov/35704381/)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Achilles Tendinopathy, Calf Injury, Sport Injury, Lower Limb Injury
- Being tested
- Ultrasound measurement of triceps surae muscle-tendon architecture
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Ultrasound measurement of triceps surae muscle-tendon architecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achille tendon cross sectional area
Mid-portion Achille tendon cross sectional area was measured (in mm²) using B mode ultrasound imaging
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Participants were classifioed as "Finishers" or "Did not finish" whether they completed the 156-km race, or not
Measured: One time point, after the race
Average speed
Average speed was calculated using the time per lap and distance for each lap
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Nov 2021
- Primary completion13 Nov 2021
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297317
- Sponsor's protocol ID
- Trailstiff
- Acronym
- Trailstiff
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35704381
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event
- ClinicalTrials.gov ID
- NCT06297317
- Acronym / sponsor ID
- Trailstiff / Trailstiff
- Conditions
- Achilles Tendinopathy, Calf Injury, Sport Injury, Lower Limb Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced long-distance trail runners | – | Diagnostic Test: Ultrasound measurement of triceps surae muscle-tendon architectureAll 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) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the participants engaged in the First Trail Scientifique de Clécy 2021(https://pubmed.ncbi.nlm.nih.gov/35704381/)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound measurement of triceps surae muscle-tendon architectureThe 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. | Diagnostic test | Experienced long-distance trail runners |
Primary outcome
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.
Mid-portion Achille tendon cross sectional area was measured (in mm²) using B mode ultrasound imaging
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.
Medial gastrocnemius thickness was measured at the inferior third of muscle llength (in mm) using B mode ultrasound imaging
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.
Medial gastrocnemius pennation angle was measured at the inferior third of muscle llength (in °) using B mode ultrasound imaging
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.
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
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.
Medial gastrocnemius muscle length was measured using an extended-field-of-view (EFOV) ultrasound imaging
2 secondary outcomes
Finisher status
Time frame: One time point, after the race
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 35704381Mauvieux 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendinopathy and Calf Injury, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.