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

NCT06110637 | Completed

• 2 other identifiers: 21CH2482022-A00219-34
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Soft-tissue vibrations; Footwear; Endurance athletes; Running; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Temporal evolution of vibrations measurements.

  Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st

• Evaluation of improved vibration damping on neuromuscular fatigue : isometric force

  From the beginning to the end of the 21 km race.

• Evaluation of improved vibration damping on neuromuscular fatigue : jerk amplitude.

  From the beginning to the end of the 21 km race.

• Evaluation of improved vibration damping on neuromuscular fatigue : level of voluntary activation.

  From the beginning to the end of the 21 km race.

• Evaluation of improved vibration damping on neuromuscular fatigue : plantar flexors.

  From the beginning to the end of the 21 km race.

Study Arms (2)

Hard shoes runners

EXPERIMENTAL

Half-marathon runners with hard shoes preceded and followed by assessment of neuromuscular fatigue.

Other: "hard shoes" runners evaluation

Soft shoes runners

ACTIVE COMPARATOR

Half-marathon runners with soft shoes preceded and followed by assessment of neuromuscular fatigue.

Other: "Soft shoes" runners evaluation

Interventions

"hard shoes" runners evaluation OTHER

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.

Hard shoes runners

"Soft shoes" runners evaluation OTHER

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.

Soft shoes runners

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• LEONARD FEASSON, MDPHD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: October 31, 2023
• Study Start: June 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 6, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)