Clinical trial NCT06110637: Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill
Official title: Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Soft-tissue vibrations
Footwear
Endurance athletes
Running
Muscle Weakness
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the damping coefficient (in percent %).
timeFrame: From the beginning to the end of the 21 km race.
Secondary outcomes:
measure: Temporal evolution of vibrations measurements.
timeFrame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st
measure: Evaluation of improved vibration damping on neuromuscular fatigue : isometric force
timeFrame: From the beginning to the end of the 21 km race.
measure: Evaluation of improved vibration damping on neuromuscular fatigue : jerk amplitude.
timeFrame: From the beginning to the end of the 21 km race.
measure: Evaluation of improved vibration damping on neuromuscular fatigue : level of voluntary activation.
timeFrame: From the beginning to the end of the 21 km race.
measure: Evaluation of improved vibration damping on neuromuscular fatigue : plantar flexors.
timeFrame: From the beginning to the end of the 21 km race.
measure: Biomechanical parameters measurement : Ground reaction forces (Newton)
timeFrame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
measure: Biomechanical parameters measurement : Spatio-temporal parameters (second)
timeFrame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
measure: Temporal evolution of the energy cost measurement
timeFrame: From the beginning to the end of the 21 km race.
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: LEONARD FEASSON, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: