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

Healthy Volunteers Clinical Trial

— FAT-VIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06110637
• Other study ID #: 21CH248
• Secondary ID: 2022-A00219-34
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 6, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy Volunteers

Intervention

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.
• "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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint-Etienne	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 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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.