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CompletedNCT04895501FAT-FLEXUpdated Jul 6, 2022

Effects of Shoe Longitudinal Bending Stiffness

An interventional study of running flexible shoes in Runners, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Runners

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Keywords

  • NEUROMUSCULAR FATIGUE
  • ENERGETIC COST OF RUNNING
  • LONGITUDINAL BENDING STIFFNESS
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    running with stiff shoes

    21 km of running with stiff shoes followed by a time-to-exhaustion run.

    Other: running flexible shoes

  • Experimental
    running flexible shoes

    21 km of running flexible shoes followed by a time-to-exhaustion run.

    Other: running flexible shoes

Interventions

  • Otherrunning flexible shoes

    21kms of running flexible shoes followed by a time-to-exhaustion run.

05

What researchers measure

Primary outcomes

  1. energy cost of running

    amount of energy needed to travel a unit of distance

    Time frame: during the last 4 minutes of a 21km race

Secondary outcomes

  1. ankle plantar flexors

    ankle plantar flexors maximal voluntary contraction

    Time frame: during the last 4 minutes of a 21km race

06

Study locations

1 site
  • Unités de Myologie et de Médecine du Sport
    Saint-Étienne, 42055, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04895501
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
May 20, 2021
Start date
Feb 7, 2022
Primary completion
May 31, 2022
Completion
Jun 28, 2022
Last update
Jul 6, 2022

Study contacts

Léonard FEASSON, Phd
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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