Back to resultsEffects of Shoe Longitudinal Bending Stiffness (FAT-FLEX)
Primary Purpose
Runners
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
running flexible shoes
Sponsored by
About this trial
This is an interventional other trial for Runners focused on measuring NEUROMUSCULAR FATIGUE, ENERGETIC COST OF RUNNING, LONGITUDINAL BENDING STIFFNESS
Eligibility 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).
Sites / Locations
- Unités de Myologie et de Médecine du Sport
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
running with stiff shoes
running flexible shoes
Arm Description
21 km of running with stiff shoes followed by a time-to-exhaustion run.
21 km of running flexible shoes followed by a time-to-exhaustion run.
Outcomes
Primary Outcome Measures
energy cost of running
amount of energy needed to travel a unit of distance
Secondary Outcome Measures
ankle plantar flexors
ankle plantar flexors maximal voluntary contraction
Full Information
NCT ID
NCT04895501
First Posted
May 17, 2021
Last Updated
July 5, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT04895501
Brief Title
Effects of Shoe Longitudinal Bending Stiffness
Acronym
FAT-FLEX
Official Title
Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Runners
Keywords
NEUROMUSCULAR FATIGUE, ENERGETIC COST OF RUNNING, LONGITUDINAL BENDING STIFFNESS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
running with stiff shoes
Arm Type
Active Comparator
Arm Description
21 km of running with stiff shoes followed by a time-to-exhaustion run.
Arm Title
running flexible shoes
Arm Type
Experimental
Arm Description
21 km of running flexible shoes followed by a time-to-exhaustion run.
Intervention Type
Other
Intervention Name(s)
running flexible shoes
Intervention Description
21kms of running flexible shoes followed by a time-to-exhaustion run.
Primary Outcome Measure Information:
Title
energy cost of running
Description
amount of energy needed to travel a unit of distance
Time Frame
during the last 4 minutes of a 21km race
Secondary Outcome Measure Information:
Title
ankle plantar flexors
Description
ankle plantar flexors maximal voluntary contraction
Time Frame
during the last 4 minutes of a 21km race
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, Phd
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unités de Myologie et de Médecine du Sport
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Shoe Longitudinal Bending Stiffness
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