Trail Sciences Clecy: Markers of Performances

NCT05538442 | Completed

• 1 other identifier: 2021-A01765-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Sports Injury

Keywords

Ultra trail; effort physiology; thermoregulation; tiredness; sleep deprivation; biology

Outcome Measures

Primary Outcomes (28)

• Core body temperature 1 changes from baseline

  Continuous monitoring of Measurment of body core temperature with e-celcius device for circadien rythm measurments.

  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)

  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

  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

  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)

  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

  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

  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.

  Comparison at the end of the race from baseline before race

• Sleep scoring through actimetry

  Continuous actimetric monitoring through a motion watch

  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

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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.

  pre day 1 before, per (lap 1 to 6) and post measurments day 1 after the race

Study Arms (1)

group

OTHER

Healthy trailer

Other: Physiological recordings

Interventions

Physiological recordings OTHER

Physiological, cognitive, biological measurments

group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• Patient under guardianship or curatorship
• Refusal of participation, impossibility to access or read the information letter
• MRI scheduled within 48 hours after the race

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Clecy Center

Clécy, France

Location

Related Publications (1)

• 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.

  PMID: 38555307 DERIVED

MeSH Terms

Conditions

Athletic Injuries; Fatigue; Sleep Deprivation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• stephane Besnard, MD

  CaenHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: September 13, 2022
• Study Start: November 9, 2021
• Primary Completion: November 14, 2021
• Study Completion: January 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-01

Locations

FR (1)