Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill (FAT-VIB)

During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: "hard shoes" runners evaluation; Other: "Soft shoes" runners evaluation

Detailed Description

Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense and/or long run remains unknown.

The purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics.

Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Endurance runners doing a long run of at least 20 km once a week.
• Affiliated or beneficiaries of a social security plan.
• Have freely given their written consent.
• Not participating in a competition during the study period.
• Shoe size 37 to 46

Exclusion Criteria:

• Any subject who has been injured in the 3 months preceding the protocol
• Any subject with chronic joint pathologies (e.g., repeated sprains, patellar or ligament problems) or cardiac pathologies.
• Any subject with chronic or central neurological pathologies
• Any subject participating at the same time in another medical interventional experiment
• Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).
• Any subject deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
• Any subject declaring to have taken products prohibited by the World Anti-Doping Agency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hard shoes runners; Half-marathon runners with hard shoes preceded and followed by assessment of neuromuscular fatigue.	Other: "hard shoes" runners evaluation; The "hard shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.
Active Comparator: Soft shoes runners; Half-marathon runners with soft shoes preceded and followed by assessment of neuromuscular fatigue.	Other: "Soft shoes" runners evaluation; The "soft shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the damping coefficient (in percent %).	The main evaluation criterion will be the relative variation (in percent %) of the damping coefficient (in /s) of the medial gastrocnemius muscle measured with an accelerometer, at the beginning (the first five minutes) and at the end (the last five minutes) of 21 km at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by experienced amateurs during two shoe conditions: soft and firm sole.	From the beginning to the end of the 21 km race.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal evolution of vibrations measurements.	The relative variation (in percent %) of the damping coefficient (in /s) of the medial gastrocnemius muscle will be measured with an accelerometer every 3 km at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by confirmed amateurs during the two shoe conditions. For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.	Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st
Evaluation of improved vibration damping on neuromuscular fatigue : isometric force	The relative change (in percent %) in the maximum isometric force (in Newton) of the ankle plantar flexors before and after the 21 km	From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : jerk amplitude.	The relative change (in percent %) in jerk amplitudes measured by electrically evoked force (in Newton) after isometric contraction of the plantar flexors of the ankle, before and after the 21 km.	From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : level of voluntary activation.	The relative change (percent %) in the maximum level of voluntary activation (percent %) measured in isometric mode of the plantar flexors of the ankle before and after the 21 km	From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : plantar flexors.	The relative change (in percent %) in the maximum isometric force (in Newton) of the plantar flexors of the toes before and after the 21 km.	From the beginning to the end of the 21 km race.
Temporal evolution of the energy cost measurement	This will be the relative variation (in percent %) of the energy cost (in J/kg/m), measured continuously thanks to a portable gas exchange measurement system (ergo spirometer Metamax 3B®, Cortex Medical, Leipzig, Germany), at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by experienced amateurs during the two shoe conditions.	From the beginning to the end of the 21 km race.
Biomechanical parameters measurement : Ground reaction forces (Newton)	Ground reaction forces (in Newton, measured by treadmill force platforms). For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.	Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
Biomechanical parameters measurement : Spatio-temporal parameters (second)	Spatio-temporal parameters: contact time (CT) and flight time (TV) For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.	Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: LEONARD FEASSON, MDPHD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Running; Muscle Weakness; Footwear; Endurance athletes; Soft-tissue vibrations
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 21CH248; 2022-A00219-34 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No