- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04895501
Effects of Shoe Longitudinal Bending Stiffness (FAT-FLEX)
July 5, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne
Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Étienne, France, 42055
- Unités de Myologie et de Médecine du Sport
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: running with stiff shoes
21 km of running with stiff shoes followed by a time-to-exhaustion run.
|
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.
|
21kms of running flexible shoes followed by a time-to-exhaustion run.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
during the last 4 minutes of a 21km race
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ankle plantar flexors
Time Frame: during the last 4 minutes of a 21km race
|
ankle plantar flexors maximal voluntary contraction
|
during the last 4 minutes of a 21km race
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 28, 2022
Study Registration Dates
First Submitted
May 17, 2021
First Submitted That Met QC Criteria
May 17, 2021
First Posted (Actual)
May 20, 2021
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21CH034
- 2021-A00726-35 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Runners
-
Keller Army Community HospitalRecruitingHealthy RunnersUnited States
-
Lake Erie College of Osteopathic MedicineLake Erie College of Osteopathic Medicine (LECOM)Completed
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Medical University of GdanskActive, not recruitingIntestinal Microbiome | Probiotic | RunnersPoland
-
Pedro Julian Flores MorenoFabian Rojas Larios; Claudia Ivette Gamboa GomezNot yet recruitingHealthy Adult Male | RunnersMexico
-
University of HaifaCompletedHealthy Runners. Compression Stocking and PerformanceIsrael
-
Hacettepe UniversityCompletedRange of Motion | Mobility | Fascia | RunnersTurkey
-
Centre Hospitalier Universitaire de Saint EtienneCompletedUltra-marathon RunnersFrance
-
Elif TunçNot yet recruitingNeuromuscular Control | Running Biomechanics | Running-Related Injury Prevention | Recreational RunnersTurkey (Türkiye)
Clinical Trials on running flexible shoes
-
Luxembourg Institute of HealthDECATHLON SACompletedRunning-Related Injury (First-time)Luxembourg
-
University of FloridaCompleted
-
Université de SherbrookeBSN Medical IncCompletedWalking Cast Right Leg Immobilisation Effects | Aircast Right Leg Immobilisation EffectsCanada
-
University GhentUniversiteit AntwerpenCompletedKnee OsteoarthritisBelgium
-
Eastern Mediterranean UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisSorbonne UniversityNot yet recruitingChronic Obstructive Pulmonary Disease (COPD) | Exercise Intolerance | DyspnoeaFrance
-
University Hospital, BrestCompleted
-
CommonSpirit HealthUniversity of Colorado, Colorado SpringsWithdrawnExercise | Blood Pressure | Body Temperature Changes
-
University Hospital, Basel, SwitzerlandCompletedCerebral PalsySwitzerland
-
University Hospital, GenevaCompleted