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Effects of Shoe Longitudinal Bending Stiffness (FAT-FLEX)

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ClinicalTrials.gov Identifier: NCT04895501
Recruitment Status : Not yet recruiting
First Posted : May 20, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
Carbon plates inserted in competitive running shoes have been increasingly used in the past 2-3 years and several investigations have shown that these plates increase the longitudinal bending stiffness (LBS) of the shoe. It leads to a redistribution of muscle work and to a modification of the force generation conditions, which may reduce the energy cost of running (Cr) and improve performance. Only one study has investigated the effects of LBS in running bouts longer than 8 minutes but on the biomechanics part, and their effects on neuromuscular fatigue and prolonged running performance. The aim of this study is to compare shoes with and without carbon plates during a prolonged (21 km) running exercise on Cr, plantar flexor neuromuscular fatigue and running kinetics and kinematics to estimate the changes high-LBS may induce on fatigue and subsequent performance.

Condition or disease Intervention/treatment Phase
Runners Other: running flexible shoes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Arm Intervention/treatment
Active Comparator: running with stiff shoes
21 km of running with stiff shoes followed by a time-to-exhaustion run.
Other: running flexible shoes
21kms of running flexible shoes followed by a time-to-exhaustion run.

Experimental: running flexible shoes
21 km of running flexible shoes followed by a time-to-exhaustion run.
Other: running flexible shoes
21kms of running flexible shoes followed by a time-to-exhaustion run.




Primary Outcome Measures :
  1. energy cost of running [ Time Frame: during the last 4 minutes of a 21km race ]
    amount of energy needed to travel a unit of distance


Secondary Outcome Measures :
  1. ankle plantar flexors [ Time Frame: during the last 4 minutes of a 21km race ]
    ankle plantar flexors maximal voluntary contraction



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged ≥ 18 and ≤ 50 years.
  • men
  • experienced, well-trained endurance runners with the capacity to run 21km in less than 1h 40 and who train more than 5h a week.
  • free from muscular, bone or joint injuries
  • free from neurologic disease
  • approval received from a physician

Exclusion Criteria:

  • currently participating in a structured exercise program
  • injury in the 3 months prior to the protocol
  • chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems)
  • the intake of corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895501


Contacts
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Contact: Léonard FEASSON, Phd 04.77.12 03 83 leonard.feasson@chu-st-etienne.fr
Contact: Arnauld GARCIN, Cra arnauld.garcin@chu-st-etienne.fr

Locations
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France
Unités de Myologie et de Médecine du Sport
Saint-Étienne, France, 42055
Contact: Léonard FEASSON, Phd    04 77 12 03 83    leonard.feasson@chu-st-etienne.fr   
Contact: Diana RIMAUD       diana.rimaud@chu-st-etienne.fr   
Sub-Investigator: Clément FOSCHIA, Dr         
Sub-Investigator: Pascal EDOUARD, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Léonard FEASSON, Phd CHU Saint-Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04895501    
Other Study ID Numbers: 21CH034
2021-A00726-35 ( Other Identifier: ANSM )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
NEUROMUSCULAR FATIGUE
ENERGETIC COST OF RUNNING
LONGITUDINAL BENDING STIFFNESS
Additional relevant MeSH terms:
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Decompression Sickness
Barotrauma
Wounds and Injuries