MedDataX Logo

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

NCT ID: NCT06110637

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Soft-tissue vibrations Footwear Endurance athletes Running Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hard shoes runners

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

Group Type EXPERIMENTAL

"hard shoes" runners evaluation

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

"Soft shoes" runners evaluation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

LEONARD FEASSON, MDPHD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-A00219-34

Identifier Type: OTHER

Identifier Source: secondary_id

21CH248

Identifier Type: -

Identifier Source: org_study_id