Healthy VolunteersFAT-VIBNCT06110637
Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill
A study testing "hard shoes" runners evaluation and "Soft shoes" runners evaluation in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- "hard shoes" runners evaluation and "Soft shoes" runners evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2022to 6 Jan 2023
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Endurance runners doing a long run of at least 20 km once a week.
- Affiliated or beneficiaries of a social security plan.
- Have freely given their written consent.
- Not participating in a competition during the study period.
- Shoe size 37 to 46
Who cannot join
- Any subject who has been injured in the 3 months preceding the protocol
- Any subject with chronic joint pathologies (e.g., repeated sprains, patellar or ligament problems) or cardiac pathologies.
- Any subject with chronic or central neurological pathologies
- Any subject participating at the same time in another medical interventional experiment
- Any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).
- Any subject deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation).
- Any subject declaring to have taken products prohibited by the World Anti-Doping Agency
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
About this study
During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.
Read the detailed description
Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense and/or long run remains unknown.
The purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics.
Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort.
- Conditions
- Healthy Volunteers
- Being tested
- "hard shoes" runners evaluation, "Soft shoes" runners evaluation
- Keywords
- Soft-tissue vibrations, Footwear, Endurance athletes, Running, Muscle Weakness
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"hard shoes" runners evaluationOther
The "hard shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.
"Soft shoes" runners evaluationOther
The "soft shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Hard shoes runners | Experimental | Half-marathon runners with hard shoes preceded and followed by assessment of neuromuscular fatigue. Receives: Other: "hard shoes" runners evaluation |
| Soft shoes runners | Active comparator | Half-marathon runners with soft shoes preceded and followed by assessment of neuromuscular fatigue. Receives: Other: "Soft shoes" runners evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the damping coefficient (in percent %).
The main evaluation criterion will be the relative variation (in percent %) of the damping coefficient (in /s) of the medial gastrocnemius muscle measured with an accelerometer, at the beginning (the first five minutes) and at the end (the last five minutes) of 21 km at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by experienced amateurs during two shoe conditions: soft and firm sole.
Measured: From the beginning to the end of the 21 km race.
Secondary outcomes (8)
Temporal evolution of vibrations measurements.
The relative variation (in percent %) of the damping coefficient (in /s) of the medial gastrocnemius muscle will be measured with an accelerometer every 3 km at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by confirmed amateurs during the two shoe conditions.
For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.
Measured: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st
Evaluation of improved vibration damping on neuromuscular fatigue : isometric force
The relative change (in percent %) in the maximum isometric force (in Newton) of the ankle plantar flexors before and after the 21 km
Measured: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : jerk amplitude.
The relative change (in percent %) in jerk amplitudes measured by electrically evoked force (in Newton) after isometric contraction of the plantar flexors of the ankle, before and after the 21 km.
Measured: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : level of voluntary activation.
The relative change (percent %) in the maximum level of voluntary activation (percent %) measured in isometric mode of the plantar flexors of the ankle before and after the 21 km
Measured: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : plantar flexors.
The relative change (in percent %) in the maximum isometric force (in Newton) of the plantar flexors of the toes before and after the 21 km.
Measured: From the beginning to the end of the 21 km race.
Biomechanical parameters measurement : Ground reaction forces (Newton)
Ground reaction forces (in Newton, measured by treadmill force platforms).
For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.
Measured: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
Biomechanical parameters measurement : Spatio-temporal parameters (second)
Spatio-temporal parameters: contact time (CT) and flight time (TV)
For this outcome, it is not possible to use an unit of time, because the time of the measurements are define only by the distance covered by the subject.
Measured: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
Temporal evolution of the energy cost measurement
This will be the relative variation (in percent %) of the energy cost (in J/kg/m), measured continuously thanks to a portable gas exchange measurement system (ergo spirometer Metamax 3B®, Cortex Medical, Leipzig, Germany), at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by experienced amateurs during the two shoe conditions.
Measured: From the beginning to the end of the 21 km race.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start15 Jun 2022
- Primary completion15 Dec 2022
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEONARD FEASSON, MDPHD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110637
- Sponsor's protocol ID
- 21CH248
- Other IDs
- 2022-A00219-34
- Acronym
- FAT-VIB
- Status last verified
- Nov 2023
- First submitted
- 18 Jul 2023
- Last updated
- 1 Dec 2023
- 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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill
- ClinicalTrials.gov ID
- NCT06110637
- Acronym / sponsor ID
- FAT-VIB / 21CH248
- Conditions
- Healthy Volunteers
- Keywords
- Soft-tissue vibrations, Footwear, Endurance athletes, Running, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 31 Oct 2023 (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.
During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.
Detailed description
Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense and/or long run remains unknown.
The purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics.
Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hard shoes runners | Experimental | Other: "hard shoes" runners evaluationHalf-marathon runners with hard shoes preceded and followed by assessment of neuromuscular fatigue. |
| Soft shoes runners | Active comparator | Other: "Soft shoes" runners evaluationHalf-marathon runners with soft shoes preceded and followed by assessment of neuromuscular fatigue. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Endurance runners doing a long run of at least 20 km once a week.
- Affiliated or beneficiaries of a social security plan.
- Have freely given their written consent.
- Not participating in a competition during the study period.
- Shoe size 37 to 46
Key exclusion criteria (7 listed)
- Any subject who has been injured in the 3 months preceding the protocol
- Any subject with chronic joint pathologies (e.g., repeated sprains, patellar or ligament problems) or cardiac pathologies.
- Any subject with chronic or central neurological pathologies
- Any subject participating at the same time in another medical interventional experiment
- Any subject who has taken 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 |
|---|---|---|
| "hard shoes" runners evaluationThe "hard shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated. | Other | Hard shoes runners |
| "Soft shoes" runners evaluationThe "soft shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated. | Other | Soft shoes runners |
Primary outcome
Change of the damping coefficient (in percent %).
Time frame: From the beginning to the end of the 21 km race.
The main evaluation criterion will be the relative variation (in percent %) of the damping coefficient (in /s) of the medial gastrocnemius muscle measured with an accelerometer, at the beginning (the first five minutes) and at the end (the last five minutes) of 21 km at a speed corresponding to 70% of the maximum aerobic speed (MAS) on a treadmill, carried out by experienced amateurs during two shoe conditions: soft and firm sole.
8 secondary outcomes
Temporal evolution of vibrations measurements.
Time frame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st
Evaluation of improved vibration damping on neuromuscular fatigue : isometric force
Time frame: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : jerk amplitude.
Time frame: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : level of voluntary activation.
Time frame: From the beginning to the end of the 21 km race.
Evaluation of improved vibration damping on neuromuscular fatigue : plantar flexors.
Time frame: From the beginning to the end of the 21 km race.
Biomechanical parameters measurement : Ground reaction forces (Newton)
Time frame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
Biomechanical parameters measurement : Spatio-temporal parameters (second)
Time frame: Kilometers : 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st.
Temporal evolution of the energy cost measurement
Time frame: From the beginning to the end of the 21 km 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 1 Dec 2023.
- 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.
LEONARD FEASSON, MDPHD principal investigator
CHU 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 "hard shoes" runners evaluation and "Soft shoes" runners evaluation in people with Healthy Volunteers, 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 5 inclusion and 7 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 1 Dec 2023. 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?
Change of the damping coefficient (in percent %). (time frame: From the beginning to the end of the 21 km 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 1 Dec 2023.