RunnersFAT-FLEXNCT04895501
Effects of Shoe Longitudinal Bending Stiffness
A study testing running flexible shoes in people with Runners, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Runners
- What is being tested?
- running flexible shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Runners
- Being tested
- running flexible shoes
- Keywords
- NEUROMUSCULAR FATIGUE, ENERGETIC COST OF RUNNING, LONGITUDINAL BENDING STIFFNESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running flexible shoesOther
21kms of running flexible shoes followed by a time-to-exhaustion run.
| Study group | Role | What they receive |
|---|---|---|
| running with stiff shoes | Active comparator | 21 km of running with stiff shoes followed by a time-to-exhaustion run. Receives: Other: running flexible shoes |
| running flexible shoes | Experimental | 21 km of running flexible shoes followed by a time-to-exhaustion run. Receives: Other: running flexible shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy cost of running
amount of energy needed to travel a unit of distance
Measured: during the last 4 minutes of a 21km race
Secondary outcomes (1)
ankle plantar flexors
ankle plantar flexors maximal voluntary contraction
Measured: during the last 4 minutes of a 21km race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start7 Feb 2022
- Primary completion31 May 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RunnersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léonard FEASSON, Phd, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895501
- Sponsor's protocol ID
- 21CH034
- Other IDs
- 2021-A00726-35
- Acronym
- FAT-FLEX
- Status last verified
- Jul 2022
- First submitted
- 17 May 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run
- ClinicalTrials.gov ID
- NCT04895501
- Acronym / sponsor ID
- FAT-FLEX / 21CH034
- Conditions
- Runners
- Keywords
- NEUROMUSCULAR FATIGUE, ENERGETIC COST OF RUNNING, LONGITUDINAL BENDING STIFFNESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| running with stiff shoes | Active comparator | Other: running flexible shoes21 km of running with stiff shoes followed by a time-to-exhaustion run. |
| running flexible shoes | Experimental | Other: running flexible shoes21 km of running flexible shoes followed by a time-to-exhaustion run. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| running flexible shoes21kms of running flexible shoes followed by a time-to-exhaustion run. | Other | running flexible shoes, running with stiff shoes |
Primary outcome
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
1 secondary outcome
ankle plantar flexors
Time frame: during the last 4 minutes of a 21km race
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Léonard FEASSON, Phd principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running flexible shoes in people with Runners, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy cost of running (time frame: during the last 4 minutes of a 21km race). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.