Muscle FatigueUT4M2018NCT03712592
Physiological Constraints Associated With Trail Running
A study testing Pre and post running evaluations in people with Muscle Fatigue, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Pre and post running evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2018to 5 Sep 2018
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman
- 18-55 years
- Absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease
- > 3 years of trail running (at least 1 race> 40 km / year completed and a race> 100 km completed (trail group 160 km)
- Medical certificate of no contraindication to the practice of the trail
- Subjects available in Grenoble before and within 15 days after the race
- Subjects affiliated to a social security scheme
- Subjects able to sign informed consent.
Who cannot join
- Cardiorespiratory, metabolic and neurological diseases
- Non-Echogenic Subjects
- Subjects with chronic sleep disorders
- Psychiatric pathologies or ATCD of behavioral disorders
- Persons refusing to sign the information sheet and the participation agreement,
- persons under guardianship or not subject to a social security scheme,
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- Pregnant woman, parturient, breastfeeding mother
- Person deprived of liberty by judicial or administrative decision,
- Person subject to a legal protection measure, who can not be included in clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).
- Conditions
- Muscle Fatigue
- Being tested
- Pre and post running evaluations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and post running evaluationsOther
Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.
Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage.
| Study group | Role | What they receive |
|---|---|---|
| 160km | Experimental | Not described Receives: Other: Pre and post running evaluations |
| 40km | Experimental | Not described Receives: Other: Pre and post running evaluations |
| 100km | Experimental | Not described Receives: Other: Pre and post running evaluations |
| 4x40km | Experimental | Not described Receives: Other: Pre and post running evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the level of ankle extensors fatigue induced by trail
Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation
Measured: one month and 12 days
Quantification of the level of knee extensors fatigue induced by trail
Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation
Measured: one month and 12 days
Quantification of the level of ankle extensors fatigue induced by trail
Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography
Measured: one month and 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start23 Jul 2018
- Primary completion23 Aug 2018
- Study completion5 Sep 2018
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 Muscle FatigueStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712592
- Sponsor's protocol ID
- 38RC18.096
- Acronym
- UT4M2018
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Besson T, Rossi J, LE Roux Mallouf T, Marechal M, Doutreleau S, Verges S, Millet GY. Fatigue and Recovery after Single-Stage versus Multistage Ultramarathon Running. Med Sci Sports Exerc. 2020 Aug;52(8):1691-1698. doi: 10.1249/MSS.0000000000002303.
PubMed 32079919
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Constraints Associated With Trail Running
- ClinicalTrials.gov ID
- NCT03712592
- Acronym / sponsor ID
- UT4M2018 / 38RC18.096
- Conditions
- Muscle Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 19 Oct 2018 (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.
The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 160km | Experimental | Other: Pre and post running evaluations |
| 40km | Experimental | Other: Pre and post running evaluations |
| 100km | Experimental | Other: Pre and post running evaluations |
| 4x40km | Experimental | Other: Pre and post running evaluations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Man or woman
- 18-55 years
- Absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease
- > 3 years of trail running (at least 1 race> 40 km / year completed and a race> 100 km completed (trail group 160 km)
- Medical certificate of no contraindication to the practice of the trail
Key exclusion criteria (9 listed)
- Cardiorespiratory, metabolic and neurological diseases
- Non-Echogenic Subjects
- Subjects with chronic sleep disorders
- Psychiatric pathologies or ATCD of behavioral disorders
- Persons refusing to sign the information sheet and the participation agreement,
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 |
|---|---|---|
| Pre and post running evaluationsEach visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake. Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage. | Other | 100km, 160km, 40km, 4x40km |
Primary outcome
Quantification of the level of ankle extensors fatigue induced by trail
Time frame: one month and 12 days
Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation
Quantification of the level of knee extensors fatigue induced by trail
Time frame: one month and 12 days
Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation
Quantification of the level of ankle extensors fatigue induced by trail
Time frame: one month and 12 days
Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography
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 29 Dec 2025.
- Results publication: PubMed 32079919Besson T, Rossi J, LE Roux Mallouf T, Marechal M, Doutreleau S, Verges S, Millet GY. Fatigue and Recovery after Single-Stage versus Multistage Ultramarathon Running. Med Sci Sports Exerc. 2020 Aug;52(8):1691-1698. doi: 10.1249/MSS.0000000000002303.
- Individual participant dataSharing planned: No
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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?
A study testing Pre and post running evaluations in people with Muscle Fatigue, run by University Hospital, Grenoble 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 8 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 29 Dec 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?
Quantification of the level of ankle extensors fatigue induced by trail (time frame: one month and 12 days). The study lists 3 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 NCT03712592, 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 29 Dec 2025.