Sports InjuryNCT05538442
Trail Sciences Clecy: Markers of Performances
A study testing Physiological recordings in people with Sports Injury, run by University Hospital, Caen at 1 site in France.
Trial summary
The Scientific Trail Protocol of Clécy - Suisse Normande (TCS) is exploratory study including several specific protocols, on a real event of 156 km on hilly terrain (6000 m of difference in level), allowing to evaluate the constraints and immediate (6000 m of difference in altitude), allowing to evaluate the… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury
- What is being tested?
- Physiological recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 31 Jan 2022
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical certificate of no contraindication to the practice of the ultra trail of less than one year and having no abnormalities in the ECG nor in the cardiac echography realized in the 2 months preceding the race.
- Runners voluntarily participating in the Trail Scientifique de Clécy (156 Km / 6000D+)
- Experienced runners who have already completed 2 ultra trail races (+/- 160km), at least one of them in the last 24 months. The subjects will have to justify their event and their ranking.
- Be affiliated to a social security system or be a beneficiary of such a system Plan
- Free and informed information given to the participant
- French language spoken and read
Show all 12Show fewer
- Healthy volunteers from 25 years old to 60 years old.
- Ability to give written consent to participate in the study.
- Usual place of living: Greenwich meridian (GMT) ± 2 hours
- Be equipped with a cardio-gps watch (Suunto, Polar, Garmin, Coros) and a Android smartphone
- Subjects who have not run a trail of more than 80 km in the 3 weeks preceding the protocol
- All participants will have to present a health pass under the legislation in force on November 11
Who cannot join
- Subjects with a medical history (pulmonary pathology, cardiac pathology, hypertension) or with known inflammatory, renal, cardiac or neurological disease.
- History of joint surgery of the ankle (e.g. arthrodesis) or foot.
- Pathology / trauma of the lower limbs
- Joint stiffness corresponding to amplitudes of less than 15° of dorsal flexion (flexion) and 35° of plantar flexion (extension)
- Major sensory disorders in the foot (loss of sensitivity).
- Central and/or peripheral neurological pathology
Show all 19Show fewer
- Swallowing disorder.
- Chronic transit disorder (UC, Crohn's disease, digestive cancer...) Recent muscular and orthopedic injuries limiting running (less than 15 days)
- Participants who have experienced a time difference of more than 2 hours in the month preceding the event (jet lag)
- Subject having run an ultra-trail (160 Km) after the period of September 2 2021
- Pregnant or breastfeeding woman
- Minor subject
- Inclusion of the subject in another biomedical research protocol during the present study
- Patient under guardianship or curatorship
- Refusal of participation, impossibility to access or read the information letter
- MRI scheduled within 48 hours after the race
- Runner under medical treatment.
- Physical or mental inability to perform the isokinetic test
- Absence of a valid health pass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics of the Determinants of Performance During an Ultra-trail
The Scientific Trail Protocol of Clécy - Suisse Normande (TCS) is exploratory study including several specific protocols, on a real event of 156 km on hilly terrain (6000 m of difference in level), allowing to evaluate the constraints and immediate (6000 m of difference in altitude), allowing to evaluate the constraints and the immediate physiological adaptations under race conditions.
The evaluations will be performed by collecting biological and neurobiological variables before, during and after the race (inflammation, hydro-electrolytic, cardiac, renal and muscular balance), physiological parameters whose thermoregulatory processes (core temperature, skin temperature, hydration), neuromuscular fatigue, cognitive performances (motivation, attention, emotion) and sleep changes (before, during and after the race).
Read the detailed description
Running has deep evolutionary roots in human history. The ability and the ability and propensity to run long distances would have appeared about 2 million years ago when humans were hunting to exhaustion in order to feed themselves with meaty foods. Today, these exceptional endurance abilities are the modern manifestation of a unique human trait that helps make humans what they are.
For 20 years, the popularity of ultra-endurance disciplines (effort whose duration is greater than 6 hours) is exponential. Ultra-trail in particular has not escaped this popular worldwide craze. At the same time, the scientific community, particularly the medical community, is beginning to take an interest in this discipline. It is important to It is important to understand how a human organism is able to produce an effort of several tens of hours hours continuously. It is necessary to measure the short, medium and long term repercussions on the health of It is necessary to measure the short, medium and long term repercussions on the health of ultra-trail to ensure its development and its practice in complete safety, in a society that is becoming more and more sedentary.
The lack of data found in the literature on these issues is essentially related to the the difficulty of setting up scientific protocols during events, associated with the preponderant place of the trail discipline, on which the project in Clécy,Normandy is originated.
A consortium composed of several local research teams (Normandy Caen University Hospital), national and international research teams, propose to set up a common protocol to better explore and understand the time course of the psychophysiological mechanisms that contribute to performance during an ultra trail. For this purpose, measurements will be taken before, during and after the Ultra Trail (156 km) in 60 voluntary and experienced runners. This scientific study, so complete with a dedicated race, is the first of its type in ultra-trail.
This experimental study will include 60 subjects, men and women, experienced in ultra trail running events and with no contraindications to the practice of this discipline.
This experimental group will participate in a 156 km / 6000mD+ race (between 24 and 60 hours of running) and will take measurements at each lap (every 26 km). Hypothesis tested: The aim of this work is to evaluate the time course of parameters contributing to the performance/skills during a run of 156 km with a positive elevation difference of 6000 m.
- Conditions
- Sports Injury
- Being tested
- Physiological recordings
- Keywords
- Ultra trail, effort physiology, thermoregulation, tiredness, sleep deprivation, biology
- Medical subject headings
- Athletic Injuries, Fatigue, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological recordingsOther
Physiological, cognitive, biological measurments
| Study group | Role | What they receive |
|---|---|---|
| group | Other | Healthy trailer Receives: Other: Physiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature 1 changes from baseline
Continuous monitoring of Measurment of body core temperature with e-celcius device for circadien rythm measurments.
Measured: continuous monitoring from Day 1 before (baseline) to Day 2 after the ultra-trail
Biomechanical properties1
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques.
- Maximum tension interpreted by peak torque at 10° of dorsal flexion (peak torque: PT in Nm)
Measured: Comparison at the end of the race from baseline before race
Biomechanical properties2
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques.
- Stiffness interpreted by the Tension/Length ratio: ΔPT/ΔL at 0-10° of extension
Measured: Comparison at the end of the race from baseline before race
Biomechanical properties3
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques.
- Elastic potential energy (W) interpreted by the area under the PT-L curve 0-10° of extension
Measured: Comparison at the end of the race from baseline before race
Spatial cognition evaluations from baseline
Evaluation of spatial orientation through virtual reality orientation test (XMaze, VRMaze software)
Measured: Comparison at the end of the race from baseline before race
Balance evaluations 1 from baseline
Evaluation of balance ability through posture measurments antero-posterior and lateral sway during eye open and closed condition
Measured: Comparison at the end of the race from baseline before race
Balance evaluations 2 from baseline
Evaluation of balance ability through posture measurments through the stability score during eye open and closed condition
Measured: Comparison at the end of the race from baseline before race
Sleep scoring changes from baseline
Sleep recordings with the somfit EEG device and quantification of wake, NREM and REM states duration.
Measured: Comparison at the end of the race from baseline before race
Sleep scoring through actimetry
Continuous actimetric monitoring through a motion watch
Measured: Comparison at the end of the race from baseline before race
Sleep scoring through heart frequency
Continuous monitoring of heart rate with a physiological suit
Measured: Comparison at the end of the race from baseline before race
Cardio-vascular evaluations changes from baseline
Estimation of acute variations of left ventricular relaxation in echocardiography echocardiography by measuring left proto-diastolic intraventricular pressure gradients
Measured: Comparison at the end of the race from baseline before race
cognitive processes 1 changes from baseline
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance.
Test to measure attention: PVT (Vigilance, 3 min)
Measured: Comparison at the end of the race from baseline before race
cognitive processes 2 changes from baseline
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance.
DSST cognitive test (Complex Deciphering and Visual Tracking, 90 seconds)
Measured: Comparison at the end of the race from baseline before race
cognitive processes 3 changes from baseline
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance.
BART Cognitive Test (Risk Decision Making, 3 min)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 1 changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection of stated footwear preferences (questionnaire)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 2a changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Measurement of biomechanics (foot placement technique)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 2b changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Measurement of biomechanics ( stride frequency)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 2c changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Measurement of biomechanics (ground contact time)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3a changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (brand)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3b changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (model)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3c changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (size)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3d changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (sole thickness)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3e changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (drop)
Measured: Comparison at the end of the race from baseline before race
shoes related biomechanic 3f changes from baseline
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner)
- Collection and measurement of the characteristics of the shoes used (internal pressures)
Measured: Comparison at the end of the race from baseline before race
Psychology and performances changes from baseline
Two computerized 2D tests (money risk test described in Schmidt et al. Plos biology 2012)
Measured: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
glycemia regulation changes from baseline
Evaluate the impact of ultra trail on the glycemic balance of Runners through a continuous interstitial glucose sensor (FreeStyle Libre Pro, Abbott): continuous measurment of capillar glycemia
Measured: continuous monitoring from two days before the race up to one seven day after the race
Fatigue and biomechanics 1 changes from baseline
Study the effects of fatigue on the biomechanics of running :running kinematics, mainly the foot placement on the ground measured with high definition video camera
Measured: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
Fatigue and biomechanics 2 changes from baseline
Study the effects of fatigue on the biomechanics of running :running kinematics, mainly the pace of the steps measured with an optogait system.
Measured: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start9 Nov 2021
- Primary completion14 Nov 2021
- Study completion31 Jan 2022
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 Sports InjuryStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephane Besnard, MD, Principal investigator, CaenHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538442
- Sponsor's protocol ID
- 2021-A01765-36
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parent C, Mauvieux B, Lespagnol E, Hingrand C, Vauthier JC, Noirez P, Hurdiel R, Martinet Q, Delaunay PL, Besnard S, Heyman J, Gabel V, Baron P, Gamelin FX, Maboudou P, Rabasa-Lhoret R, Jouffroy R, Heyman E. Glycaemic Effects of a 156-km Ultra-trail Race in Athletes: An Observational Field Study. Sports Med. 2024 Aug;54(8):2169-2184. doi: 10.1007/s40279-024-02013-4. Epub 2024 Mar 30.
PubMed 38555307
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of the Determinants of Performance During an Ultra-trail
- ClinicalTrials.gov ID
- NCT05538442
- Acronym / sponsor ID
- 2021-A01765-36
- Conditions
- Sports Injury
- Keywords
- Ultra trail, effort physiology, thermoregulation, tiredness, sleep deprivation, biology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Sep 2022 (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 Scientific Trail Protocol of Clécy - Suisse Normande (TCS) is exploratory study including several specific protocols, on a real event of 156 km on hilly terrain (6000 m of difference in level), allowing to evaluate the constraints and immediate (6000 m of difference in altitude), allowing to evaluate the constraints and the immediate physiological adaptations under race conditions.
The evaluations will be performed by collecting biological and neurobiological variables before, during and after the race (inflammation, hydro-electrolytic, cardiac, renal and muscular balance), physiological parameters whose thermoregulatory processes (core temperature, skin temperature, hydration), neuromuscular fatigue, cognitive performances (motivation, attention, emotion) and sleep changes (before, during and after the race).
Detailed description
Running has deep evolutionary roots in human history. The ability and the ability and propensity to run long distances would have appeared about 2 million years ago when humans were hunting to exhaustion in order to feed themselves with meaty foods. Today, these exceptional endurance abilities are the modern manifestation of a unique human trait that helps make humans what they are.
For 20 years, the popularity of ultra-endurance disciplines (effort whose duration is greater than 6 hours) is exponential. Ultra-trail in particular has not escaped this popular worldwide craze. At the same time, the scientific community, particularly the medical community, is beginning to take an interest in this discipline. It is important to It is important to understand how a human organism is able to produce an effort of several tens of hours hours continuously. It is necessary to measure the short, medium and long term repercussions on the health of It is necessary to measure the short, medium and long term repercussions on the health of ultra-trail to ensure its development and its practice in complete safety, in a society that is becoming more and more sedentary.
The lack of data found in the literature on these issues is essentially related to the the difficulty of setting up scientific protocols during events, associated with the preponderant place of the trail discipline, on which the project in Clécy,Normandy is originated.
A consortium composed of several local research teams (Normandy Caen University Hospital), national and international research teams, propose to set up a common protocol to better explore and understand the time course of the psychophysiological mechanisms that contribute to performance during an ultra trail. For this purpose, measurements will be taken before, during and after the Ultra Trail (156 km) in 60 voluntary and experienced runners. This scientific study, so complete with a dedicated race, is the first of its type in ultra-trail.
This experimental study will include 60 subjects, men and women, experienced in ultra trail running events and with no contraindications to the practice of this discipline.
This experimental group will participate in a 156 km / 6000mD+ race (between 24 and 60 hours of running) and will take measurements at each lap (every 26 km). Hypothesis tested: The aim of this work is to evaluate the time course of parameters contributing to the performance/skills during a run of 156 km with a positive elevation difference of 6000 m.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group | Other | Other: Physiological recordingsHealthy trailer |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Medical certificate of no contraindication to the practice of the ultra trail of less than one year and having no abnormalities in the ECG nor in the cardiac echography realized in the 2 months preceding the race.
- Runners voluntarily participating in the Trail Scientifique de Clécy (156 Km / 6000D+)
- Experienced runners who have already completed 2 ultra trail races (+/- 160km), at least one of them in the last 24 months. The subjects will have to justify their event and their ranking.
- Be affiliated to a social security system or be a beneficiary of such a system Plan
- Free and informed information given to the participant
Key exclusion criteria (19 listed)
- Subjects with a medical history (pulmonary pathology, cardiac pathology, hypertension) or with known inflammatory, renal, cardiac or neurological disease.
- History of joint surgery of the ankle (e.g. arthrodesis) or foot.
- Pathology / trauma of the lower limbs
- Joint stiffness corresponding to amplitudes of less than 15° of dorsal flexion (flexion) and 35° of plantar flexion (extension)
- Major sensory disorders in the foot (loss of sensitivity).
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 |
|---|---|---|
| Physiological recordingsPhysiological, cognitive, biological measurments | Other | group |
Primary outcome
Core body temperature 1 changes from baseline
Time frame: continuous monitoring from Day 1 before (baseline) to Day 2 after the ultra-trail
Continuous monitoring of Measurment of body core temperature with e-celcius device for circadien rythm measurments.
Biomechanical properties1
Time frame: Comparison at the end of the race from baseline before race
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques. - Maximum tension interpreted by peak torque at 10° of dorsal flexion (peak torque: PT in Nm)
Biomechanical properties2
Time frame: Comparison at the end of the race from baseline before race
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques. - Stiffness interpreted by the Tension/Length ratio: ΔPT/ΔL at 0-10° of extension
Biomechanical properties3
Time frame: Comparison at the end of the race from baseline before race
To study the variation of passive myotendinous mechanical properties of the suro-spinal complex by elastography techniques. - Elastic potential energy (W) interpreted by the area under the PT-L curve 0-10° of extension
Spatial cognition evaluations from baseline
Time frame: Comparison at the end of the race from baseline before race
Evaluation of spatial orientation through virtual reality orientation test (XMaze, VRMaze software)
Balance evaluations 1 from baseline
Time frame: Comparison at the end of the race from baseline before race
Evaluation of balance ability through posture measurments antero-posterior and lateral sway during eye open and closed condition
Balance evaluations 2 from baseline
Time frame: Comparison at the end of the race from baseline before race
Evaluation of balance ability through posture measurments through the stability score during eye open and closed condition
Sleep scoring changes from baseline
Time frame: Comparison at the end of the race from baseline before race
Sleep recordings with the somfit EEG device and quantification of wake, NREM and REM states duration.
Sleep scoring through actimetry
Time frame: Comparison at the end of the race from baseline before race
Continuous actimetric monitoring through a motion watch
Sleep scoring through heart frequency
Time frame: Comparison at the end of the race from baseline before race
Continuous monitoring of heart rate with a physiological suit
Cardio-vascular evaluations changes from baseline
Time frame: Comparison at the end of the race from baseline before race
Estimation of acute variations of left ventricular relaxation in echocardiography echocardiography by measuring left proto-diastolic intraventricular pressure gradients
cognitive processes 1 changes from baseline
Time frame: Comparison at the end of the race from baseline before race
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance. Test to measure attention: PVT (Vigilance, 3 min)
cognitive processes 2 changes from baseline
Time frame: Comparison at the end of the race from baseline before race
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance. DSST cognitive test (Complex Deciphering and Visual Tracking, 90 seconds)
cognitive processes 3 changes from baseline
Time frame: Comparison at the end of the race from baseline before race
Determine how cognitive performance (decision making, alertness) is altered by the test and discriminate the effect of exercise and sleep disturbance. BART Cognitive Test (Risk Decision Making, 3 min)
shoes related biomechanic 1 changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection of stated footwear preferences (questionnaire)
shoes related biomechanic 2a changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Measurement of biomechanics (foot placement technique)
shoes related biomechanic 2b changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Measurement of biomechanics ( stride frequency)
shoes related biomechanic 2c changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Measurement of biomechanics (ground contact time)
shoes related biomechanic 3a changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (brand)
shoes related biomechanic 3b changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (model)
shoes related biomechanic 3c changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (size)
shoes related biomechanic 3d changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (sole thickness)
shoes related biomechanic 3e changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (drop)
shoes related biomechanic 3f changes from baseline
Time frame: Comparison at the end of the race from baseline before race
To study the relationship between the pair of shoes worn and the morphological, biomechanical and sensory characteristics of the ultra-endurance runner- Measurement of foot dimensions (scanner) - Collection and measurement of the characteristics of the shoes used (internal pressures)
Psychology and performances changes from baseline
Time frame: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
Two computerized 2D tests (money risk test described in Schmidt et al. Plos biology 2012)
glycemia regulation changes from baseline
Time frame: continuous monitoring from two days before the race up to one seven day after the race
Evaluate the impact of ultra trail on the glycemic balance of Runners through a continuous interstitial glucose sensor (FreeStyle Libre Pro, Abbott): continuous measurment of capillar glycemia
Fatigue and biomechanics 1 changes from baseline
Time frame: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
Study the effects of fatigue on the biomechanics of running :running kinematics, mainly the foot placement on the ground measured with high definition video camera
Fatigue and biomechanics 2 changes from baseline
Time frame: pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race
Study the effects of fatigue on the biomechanics of running :running kinematics, mainly the pace of the steps measured with an optogait system.
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 21 Sep 2022.
- Derived from this study: PubMed 38555307Parent C, Mauvieux B, Lespagnol E, Hingrand C, Vauthier JC, Noirez P, Hurdiel R, Martinet Q, Delaunay PL, Besnard S, Heyman J, Gabel V, Baron P, Gamelin FX, Maboudou P, Rabasa-Lhoret R, Jouffroy R, Heyman E. Glycaemic Effects of a 156-km Ultra-trail Race in Athletes: An Observational Field Study. Sports Med. 2024 Aug;54(8):2169-2184. doi: 10.1007/s40279-024-02013-4. Epub 2024 Mar 30.
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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.
stephane Besnard, MD principal investigator
CaenHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological recordings in people with Sports 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 12 inclusion and 19 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 21 Sep 2022. 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?
Core body temperature 1 changes from baseline (time frame: continuous monitoring from Day 1 before (baseline) to Day 2 after the ultra-trail). The study lists 28 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 NCT05538442, 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 21 Sep 2022.