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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06282341
Other study ID # 23CH132
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 28, 2023
Est. completion date September 2025

Study information

Verified date January 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Leonard FEASSON, MD PhD
Phone 04 77 12 03 83
Email leonard.feasson@chu-saint-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert…) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.


Description:

Some studies focused on fatigue and recovery following 30-to-40-km trail races or marathon but no direct comparison between both disciplines have been done yet. A direct comparison between marathon and trail would aim to better understand if the occurrence of fatigue is more important or if the recovery is longer in one of the two disciplines. The comparison is also a way to better understand mechanisms involved in fatigue and recovery following a trail and a marathon. Then, this research could be applied to improve specificity of training and prevent risk of injuries. This project aims to compare fatigue and recovery following a trail and a marathon.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 2025
Est. primary completion date August 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: Common for MARASIM, TRAILSIM and TRAILNAT: - Male or female - 18-55 years old - Endurance runners who run at least one running session of 20 km per week - Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years - Refrain from participating to a competition one month before the first visit and during the duration of the study - To have a medical certificate of no contraindication of running practise in competition - Registered with a social security scheme - Having given the written consent freely Specific for the 3 groups : - Specialist of trail running (TRAILSIM and TRAILNAT) - Specialist of road running (MARASIM) Exclusion Criteria: - Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems) - Subjects who present chronic or central neurological pathologies - Subjects deprived of liberty or who should be legally deprived - Subjects who report to take forbidden products by the World Anti-Doping Agency - pregnant or breastfeeding woman

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Race: Simulated marathon
Participants will take part in a race: simulated marathon. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
Race: Simulated trail
Participants will take part in a race: simulated trail. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
Race: Trail in nature
Participants will take part in a race: trail in nature. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.

Locations

Country Name City State
France Unités de Myologie et de Médecine du Sport Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knee extensors maximal isometric torque output The primary outcome will be changed (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured at D0 (= day of the race) with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), before (baseline value = 30 min before the race) and at the end (15 min after the race) of a marathon or a trail (depending on the group) Day 0 (day of the race) baseline value = 30 min before the race and 15 min after the race
Secondary Change in plantar flexor maximal isometric torque output Change (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the plantar flexor measured at D0, by an instrumental pedal placed at 45 degrees with respect to the horizontal (ATI Industrial Automation, Inc., Apex, North Carolina USA), before (baseline value) and at the end of a marathon or a trail (depending on the group), and during recovery at Day1 Day2 Day7). Day 0 (day of the race) baseline value = 30 min before the race and 15 min after the race, Days 1, 2, 7
Secondary Recovery of quadriceps maximal isometric torque output the month after the race Change (in % of post-exercise baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), during recovery at Day 1 Day 2 Day 7). Day 0 (day of the race) baseline value = 30 min before the race, (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Voluntary activation level Voluntary activation level (in %) of the plantar flexors and knee extensors will be assessed through neuromuscular assessments before, in the middle (except for the trail in the nature), after the marathon or trail of equivalent effort, and during recovery (Day 1, Day 2, and Day 7).
Voluntary activation level will be calculated as followed:
VA (%) = (1- (superimposed Db100/ resting Db100))x100
D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;(D1 (= 24h after the end of the race) , D2 (= 48 after the end of the race), D7 (= 7 days after the end
Secondary Force assessed in dynamic Force assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Force (N) will be measured in order to establish a force-velocity / power- velocity profile at Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end) of equivalent effort, and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race). Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Velocity assessed in dynamic Velocity assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Speed (rad/s) will be measured in order to establish a force-velocity / power-velocity profile before (=15 min before the race), after the marathon or trail (=1 h after the end) of equivalent effort, and during recovery (Day 1 = 24h after the end of the race, Day 2 = 48h after the end of the race, Day 7 = 7 days after the end of the race). Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Power assessed in dynamic Power assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Power (W) will be measured in order to establish a force-velocity / power-velocity profile before (=15 min before the race), after the marathon or trail (=1 h after the end) of equivalent effort, and during recovery (Day 1 = 24h after the enf of the race, Day 2=45h after the end of the race, Day 7= 7 days after the race). Day 0,15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Muscular power and stretch-shortening cycle assessed through squat jumps Muscular power and stretch-shortening cycle assessed through squat jump ; Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland).
Day 0 : 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day7 (= 7 days after the end of the race).
Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Muscular power and stretch-shortening cycle assessed through countermovement jump Muscular power and stretch-shortening cycle assessed through countermovement. Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland) Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race). Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Muscular power and stretch-shortening cycle assessed through drop jump Muscular power and stretch-shortening cycle assessed through drop jump. Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland) Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race). Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Muscle electrical activity Muscle electrical activity (Trigno avanti Sensor, Delsys, Natick, MA including electrodes connected to thin-10-cm-long cables) are measured Day 0: 30 min before the race, in the middle (except for the trail in the nature) 15 min after the end of the race : the marathon or trail of equivalent effort., and during all neuromuscular assessments Day 0: 30 min before the race, in the middle (except for the trail in the nature) 15 min after the end of the race
Secondary The kinetics of energy cost The kinetics of energy cost (Ccr en J/kg/m) measured using a portable gas exchange measurement system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany) 1h30 before the race, in the middle (except for the trail in the nature) and 30 min after the race the marathon or simulated trail and during recovery (Day 1, Day 2, Day 7).measurement system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany) Day 0 1h30 min before the race,in the middle, 30 min after the end of the race, and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Racing kinematics Evolution of moments and hip joint angles, knee and ankle measured by a Markerless tracking system will be measured
1 h before the race , in the middle (except for the trail in the nature), immediately after the simulated trail or marathon, and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
1h before, in the middle and immediately after the race and during recovery(Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Ground reaction force (in Newton) Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany). to get the ground reaction forces at each step 1h before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race). 1h before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Center of pressure (in Newton) Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany). to get the center of pressure each step before (=1 h before), in the middle (except for the trail in the nature), after (=immediately after the race) the simulated trail or marathon, and during recovery (Day 1 = 24 h after the race, Day 2 = 48 h after the race, Day 7 = 7 days after the race) 1h before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Muscle damage blood markers witness muscle damage following a marathon or a trail of equivalent effort. Biological variables are taken 2h before the race and 2 h after the race: a marathon or a trail of equivalent effort, and during recovery ((Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).). Followed i- Inflammatory parameters are taken through blood test (2 tubes of 5 ml/blood test): ionogram (sodium [mmol/l], potassium [mmol/l], chlorine [mmol/l], bicarbonates [mmol/l], urea [mmol/l], creatinine [µmol/l], glucose [mmol/l], proteins [g/l], uric acid [[µmol/l ], osmolality [m0smol/kg]; Creatine Kinase (UI/l)myoglobine [µg/l ], C reactive Protein [mg/l], lactate [mmol/l] Day 0: 2h bebore the race, 2h after the race and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 after the end of the race), Day 7 (= 7 days after the end of the race).
Secondary Resting heart rate variability parameters Evolution of resting heart rate variability, a marker of psychophysiological recovery will be assessed through a Polar H10 heart rate monitor before the race (at least 3 times in the 2 weeks before the race) and during recovery (at least every two days until one month after the race).
Analysis of time domain and frequency domain variables via measurement of heart rate variability will be achieved through HRV analysis software.
3 times in the 2 weeks before the race and every other day for the month following the race
Secondary Effort perception Perception of effort will be assessed during the marathon or trail of equivalent effort every 5 km effort on the modified Borg scale (from 0 - rest to 10 - Maximal perceived effort). during the race ,every 5 km effort
Secondary fatigue assessment Fatigue assessment will be carried out before (=once during the 2 weeks before the race) the marathon or trail of equivalent effort , immediately after and during recovery (Day 1 = 24 h after the race, Day 2 = 48 h after the race, Day 3 = 72 h after the race, Day 4 = 4 days after the race, Day 5 = 5 days after the race, Day 6 = 6 days after the race, Day 7 = 7 days after the race, Day 14 = 14 days after the race, Day 21 = 21 days after the race, Day 30 = 30 days after the race) via the of the "Rating scale of fatigue " (from 0 - Not fatigued at all to 10 - Total exhaustion nothing left). once during 2 weeks before, immediately after the race and during recoverey (Day 1 = 24 h after the race, Day 2 = 48 h after, Day 3 = 72 h after, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21 and Day 30 after the race
Secondary Muscular pain Muscle pain felt in the quadriceps and calves will be rated on a visual analog scale ranging from 0 (No muscular pain at all) at 10 (Unbearable muscle pain) during the marathon or trail of equivalent effort every 5 km-effort during the race every 5 km effort
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