NCT04895501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

May 17, 2021

Last Update Submit

July 5, 2022

Conditions

Runners

Keywords

NEUROMUSCULAR FATIGUEENERGETIC COST OF RUNNINGLONGITUDINAL BENDING STIFFNESS

Outcome Measures

Primary Outcomes (1)

  • energy cost of running

    amount of energy needed to travel a unit of distance

    during the last 4 minutes of a 21km race

Secondary Outcomes (1)

  • ankle plantar flexors

    during the last 4 minutes of a 21km race

Study Arms (2)

running with stiff shoes

ACTIVE COMPARATOR

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

Other: running flexible shoes

running flexible shoes

EXPERIMENTAL

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

Other: running flexible shoes

Interventions

running flexible shoesOTHER

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

running flexible shoesrunning with stiff shoes

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unités de Myologie et de Médecine du Sport

Saint-Etienne, 42055, France

Location

Study Officials

  • Léonard FEASSON, Phd

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

February 7, 2022

Primary Completion

May 31, 2022

Study Completion

June 28, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)