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Trail Sciences Clecy: Markers of Performances

Primary Purpose

Sports Injury

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Physiological recordings

About this trial

This is an interventional basic science trial for Sports Injury focused on measuring Ultra trail, effort physiology, thermoregulation, tiredness, sleep deprivation, biology

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Clecy Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

group

Arm Description

Healthy trailer

Outcomes

Primary Outcome Measures

Core body temperature 1 changes from baseline

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

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)

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

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

Spatial cognition evaluations from baseline

Evaluation of spatial orientation through virtual reality orientation test (XMaze, VRMaze software)

Balance evaluations 1 from baseline

Evaluation of balance ability through posture measurments antero-posterior and lateral sway during eye open and closed condition

Balance evaluations 2 from baseline

Evaluation of balance ability through posture measurments through the stability score during eye open and closed condition

Sleep scoring changes from baseline

Sleep recordings with the somfit EEG device and quantification of wake, NREM and REM states duration.

Sleep scoring through actimetry

Continuous actimetric monitoring through a motion watch

Sleep scoring through heart frequency

Continuous monitoring of heart rate with a physiological suit

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

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)

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)

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)

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)

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)

shoes related biomechanic 2b changes from baseline

shoes related biomechanic 2c changes from baseline

shoes related biomechanic 3a changes from baseline

shoes related biomechanic 3b changes from baseline

shoes related biomechanic 3c changes from baseline

shoes related biomechanic 3d changes from baseline

shoes related biomechanic 3e changes from baseline

shoes related biomechanic 3f changes from baseline

Psychology and performances changes from baseline

Two computerized 2D tests (money risk test described in Schmidt et al. Plos biology 2012)

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05538442

First Posted

January 31, 2022

Last Updated

September 19, 2022

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT05538442

Brief Title

Trail Sciences Clecy: Markers of Performances

Official Title

Kinetics of the Determinants of Performance During an Ultra-trail

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 9, 2021 (Actual)

Primary Completion Date

November 14, 2021 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sports Injury

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group

Arm Type

Other

Arm Description

Healthy trailer

Intervention Type

Other

Intervention Name(s)

Physiological recordings

Intervention Description

Physiological, cognitive, biological measurments

Primary Outcome Measure Information:

Title

Core body temperature 1 changes from baseline

Description

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

Time Frame

continuous monitoring from Day 1 before (baseline) to Day 2 after the ultra-trail

Title

Biomechanical properties1

Description

Time Frame