Neuromuscular FatiguePhase 2QIFNCT04943510
Characterization of Hamstring and Quadriceps Neuromuscular Fatigue After Soccer Game
A Phase 2 study testing Physical exercices in people with Neuromuscular Fatigue and Exercise, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This is a monocentric study comparing hamstring and quadriceps neuromuscular fatigue after simulated soccer game, anaerobic and aerobic training sessions. The purpose of this study was: 1. To quantify the decrease of isometric force immediately after a simulate soccer game. 2. Read more about this study
- Who is it for?
- Ages 16 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Fatigue, Exercise
- What is being tested?
- Physical exercices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2021to Jul 2023
- Phase
- Phase 2
- 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 16 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male
- age limits: minimum: 16 ; maximum: 40 years old
- to be a soccer player, licensed to the French Football Federation
- affiliation to the social health insurance scheme
- signing an informed consent form
Who cannot join
- impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, …)
- subject under the protection of justice
- subject under guardianship or curatorship
- lower limbs musculotendinous or articular problems
- smoker or having been a smoker in the last 5 years
- subject wearing a pacemaker
- drug treatment in progress and impossibility to stop it within 7 days before the beginning of the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67091
Bernard Geny, Pr, 03.69.55.13.41, bernard.geny@chru-strasbourg.fr
Bernard Geny, Pr
About this study
Official title: Characterization of Hamstring and Quadriceps Neuromuscular Fatigue After Different Modality of Training in Soccer Players
This is a monocentric study comparing hamstring and quadriceps neuromuscular fatigue after simulated soccer game, anaerobic and aerobic training sessions. The purpose of this study was:
- To quantify the decrease of isometric force immediately after a simulate soccer game.
- To characterize peripheral and central fatigue between hamstring and quadriceps muscles and described the kinetics of recovery after specific tasks of soccer training.
- To compare the level neuromuscular fatigue induced by anaerobic and aerobic training.
- To highlight correlation between neuromuscular fatigue and performance markers.
- Conditions
- Neuromuscular Fatigue, Exercise
- Being tested
- Physical exercices
- Keywords
- Hamstring, Neuromuscular fatigue, Soccer, Performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercicesOther
Also called Non invasive muscular neurostimulations, Surface EMG
surface EMG: surface electrodes will be positioned on the muscles to evaluate the level of muscle activation
non invasive muscular neurostimulations : application of a percutaneous electrical stimulation of the motor nerve of the considered muscle and a direct electrical stimulation of the muscle
| Study group | Role | What they receive |
|---|---|---|
| Physical exercices arm | Experimental | three randomizations will be used to determine the order of the tests that will be proposed to the subjects: on the one hand for the exercise modalities (match, anaerobic, aerobic) and, on the other hand, for the exercise modalities included in the anaerobic and aerobic exercise families: Anaerobic agility / anaerobic - linear sprints Aerobic - shuttle / aerobic - linear Receives: Other: Physical exercices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in maximal isometric hamstring strength before and immediately after exercise (i.e., pre vs. immediate post exercise) expressed as a percentage (%).
Measured: Before and immediately post exercise (i.e., during the first minute after cessation of exercise)
Secondary outcomes (11)
Relative difference (in %) in maximum isometric hamstring strength before and after exercise (i.e., pre- vs. post-exercise), relative to pre-exercise strength across different test types.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Relative difference (in %) in maximal isometric quadriceps strength before and after exercise (i.e., pre vs. post exercise), related to preexercise strength according to the different types of tests.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Relative difference (%) in maximum isometric hamstring and quadriceps strength for each test type at the different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in pre- and post-exercise (i.e., pre- vs. post-exercise) hamstring potentiated jerk amplitude (N) relative to pre-exercise amplitude by event type at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in pre- and post-exercise (i.e., pre- vs. post-exercise) potentiated jerk amplitude (N) of the quadriceps, relative to pre-exercise amplitude, by test type at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in amplitude of the potentiated jerk (N) before and after exercise, related to the preexercise amplitude according to the muscle involved (hamstrings or quadriceps) and the type of test at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary hamstring activation, expressed in newtons (N), before and after exercise, related to the pre-exercise action level, according to the type of test at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary quadriceps activation, expressed in newtons (N), before and after exercise, related to the pre-exercise action level, according to the type of test at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary action before and after exercise, related to the level of action before exercise, according to the muscle involved (hamstrings or quadriceps) and the type of test at different times of interest.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Differences in overall fatigue, peripheral fatigue, and central fatigue of hamstrings versus quadriceps between exercise modalities.
Determine the modalities of exercises which induce the highest level of fatigue and characterize the etiology of neuromuscular fatigue (i.e., peripheral or central) for typical drills performed daily by elite soccer players
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Ratio (%) of initial to post-exercise values based on field indicators and neuromuscular fatigue.
Measured: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start4 Nov 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular FatigueStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- three randomizations will be used to determine the order of the tests that will be proposed to the subjects: * on the one hand for the exercise modalities (match, anaerobic, aerobic) * and, on the other hand, for the exercise modalities included in the anaerobic and aerobic exercise families: Anaerobic agility / anaerobic - linear sprints Aerobic - shuttle / aerobic - linear
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943510
- Sponsor's protocol ID
- 8168
- Acronym
- QIF
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Hamstring and Quadriceps Neuromuscular Fatigue After Different Modality of Training in Soccer Players
- ClinicalTrials.gov ID
- NCT04943510
- Acronym / sponsor ID
- QIF / 8168
- Conditions
- Neuromuscular Fatigue, Exercise
- Keywords
- Hamstring, Neuromuscular fatigue, Soccer, Performance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Jun 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.
This is a monocentric study comparing hamstring and quadriceps neuromuscular fatigue after simulated soccer game, anaerobic and aerobic training sessions. The purpose of this study was:
- To quantify the decrease of isometric force immediately after a simulate soccer game.
- To characterize peripheral and central fatigue between hamstring and quadriceps muscles and described the kinetics of recovery after specific tasks of soccer training.
- To compare the level neuromuscular fatigue induced by anaerobic and aerobic training.
- To highlight correlation between neuromuscular fatigue and performance markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- three randomizations will be used to determine the order of the tests that will be proposed to the subjects: * on the one hand for the exercise modalities (match, anaerobic, aerobic) * and, on the other hand, for the exercise modalities included in the anaerobic and aerobic exercise families: Anaerobic agility / anaerobic - linear sprints Aerobic - shuttle / aerobic - linear
| Arm | Type | Receives |
|---|---|---|
| Physical exercices arm | Experimental | Other: Physical exercicesthree randomizations will be used to determine the order of the tests that will be proposed to the subjects: on the one hand for the exercise modalities (match, anaerobic, aerobic) and, on the other hand, for the exercise modalities included in the anaerobic and aerobic exercise families: Anaerobic agility / anaerobic - linear sprints Aerobic - shuttle / aerobic - linear |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- male
- age limits: minimum: 16 ; maximum: 40 years old
- to be a soccer player, licensed to the French Football Federation
- affiliation to the social health insurance scheme
- signing an informed consent form
Key exclusion criteria (7 listed)
- impossibility to give the subject enlightened information (subject in emergency situation, difficulties in understanding the study, …)
- subject under the protection of justice
- subject under guardianship or curatorship
- lower limbs musculotendinous or articular problems
- smoker or having been a smoker in the last 5 years
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 |
|---|---|---|
| Physical exercicesAlso: Non invasive muscular neurostimulations, Surface EMGsurface EMG: surface electrodes will be positioned on the muscles to evaluate the level of muscle activation non invasive muscular neurostimulations : application of a percutaneous electrical stimulation of the motor nerve of the considered muscle and a direct electrical stimulation of the muscle | Other | Physical exercices arm |
Primary outcome
Difference in maximal isometric hamstring strength before and immediately after exercise (i.e., pre vs. immediate post exercise) expressed as a percentage (%).
Time frame: Before and immediately post exercise (i.e., during the first minute after cessation of exercise)
11 secondary outcomes
Relative difference (in %) in maximum isometric hamstring strength before and after exercise (i.e., pre- vs. post-exercise), relative to pre-exercise strength across different test types.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Relative difference (in %) in maximal isometric quadriceps strength before and after exercise (i.e., pre vs. post exercise), related to preexercise strength according to the different types of tests.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Relative difference (%) in maximum isometric hamstring and quadriceps strength for each test type at the different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in pre- and post-exercise (i.e., pre- vs. post-exercise) hamstring potentiated jerk amplitude (N) relative to pre-exercise amplitude by event type at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in pre- and post-exercise (i.e., pre- vs. post-exercise) potentiated jerk amplitude (N) of the quadriceps, relative to pre-exercise amplitude, by test type at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in amplitude of the potentiated jerk (N) before and after exercise, related to the preexercise amplitude according to the muscle involved (hamstrings or quadriceps) and the type of test at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary hamstring activation, expressed in newtons (N), before and after exercise, related to the pre-exercise action level, according to the type of test at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary quadriceps activation, expressed in newtons (N), before and after exercise, related to the pre-exercise action level, according to the type of test at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Difference in the level of voluntary action before and after exercise, related to the level of action before exercise, according to the muscle involved (hamstrings or quadriceps) and the type of test at different times of interest.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Differences in overall fatigue, peripheral fatigue, and central fatigue of hamstrings versus quadriceps between exercise modalities.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Ratio (%) of initial to post-exercise values based on field indicators and neuromuscular fatigue.
Time frame: Before and immediately post exercise, 5, 10, 15, 30-minutes and 24 and 48-hours post-exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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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.
Hopitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical exercices in people with Neuromuscular Fatigue and Exercise, run by University Hospital, Strasbourg, France 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: status not confirmed, as of the sponsor's last update on 27 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in maximal isometric hamstring strength before and immediately after exercise (i.e., pre vs. immediate post exercise) expressed as a percentage (%). (time frame: Before and immediately post exercise (i.e., during the first minute after cessation of exercise)). 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 27 Apr 2022.