Skip to main content
OpenTrials
Completed

NCT Number: NCT06110637

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

"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.

Primary outcomes

  1. Change of the damping coefficient (in percent %).

    Time frame: From the beginning to the end of the 21 km race.

    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.

Secondary outcomes

  1. Temporal evolution of vibrations measurements.

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

    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.

  2. Evaluation of improved vibration damping on neuromuscular fatigue : isometric force

    Time frame: From the beginning to the end of the 21 km race.

    The relative change (in percent %) in the maximum isometric force (in Newton) of the ankle plantar flexors before and after the 21 km

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

    Time frame: From the beginning to the end of the 21 km race.

    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.

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

    Time frame: From the beginning to the end of the 21 km race.

    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

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

    Time frame: From the beginning to the end of the 21 km race.

    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.

  6. Biomechanical parameters measurement : Ground reaction forces (Newton)

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

    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.

  7. Biomechanical parameters measurement : Spatio-temporal parameters (second)

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

    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.

  8. Temporal evolution of the energy cost measurement

    Time frame: From the beginning to the end of the 21 km race.

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: FAT-VIB

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 31, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.