HealthyPOLYGENDOMUSNCT06740136
Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS)
A study testing Exercise in people with Healthy, run by Lille University at 1 site in France.
Trial summary
The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2023to 28 Jun 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Aged between 18 and 35
- Weighing more than 50 kg
- Member of a sports club affiliated to an Olympic federation
- Socially insured
- Willing to comply with all study procedures and duration of the study
Who cannot join
- Medical history contraindicating sporting activities
- Current medical treatment
- Not a member of a sports club affiliated to an Olympic federation
- Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS) / Déterminants génétiques Des Dommages Musculaires Induits Par l'Exercice (POLYGENDOMUS)
The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.
Read the detailed description
Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- Muscle damage, Single nucleotide polymorphism, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Muscle induced-damage eccentric exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | exercise group Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation
Association between blood creatine kinase level variations and single nucleotide polymorphisms.
The Outcome Measure in this study is focused on the variation in plasma CPK levels following an exercise inducing muscle damage. The result is expressed as a change in plasma CPK concentration, measured in units per liter (U/L). This single measurement is used to investigate its association with genetic polymorphisms. Therefore a regression analysis will be performed to identify the association. This study is exploratory and the genetic polymorphisms are not pre-identified but will be investigated through a comprehensive analysis.
Measured: Evolution of kinetics from Day 0 to Day 3 post experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start13 Mar 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention model
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740136
- Sponsor's protocol ID
- 2022-007
- Other IDs
- 2022-A01308-35
- Acronym
- POLYGENDOMUS
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS) / Déterminants génétiques Des Dommages Musculaires Induits Par l'Exercice (POLYGENDOMUS)
- ClinicalTrials.gov ID
- NCT06740136
- Acronym / sponsor ID
- POLYGENDOMUS / 2022-007
- Conditions
- Healthy
- Keywords
- Muscle damage, Single nucleotide polymorphism, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lille UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 18 Dec 2024 (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.
The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.
Detailed description
Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention model
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exerciseexercise group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female
- Aged between 18 and 35
- Weighing more than 50 kg
- Member of a sports club affiliated to an Olympic federation
- Socially insured
Key exclusion criteria (4 listed)
- Medical history contraindicating sporting activities
- Current medical treatment
- Not a member of a sports club affiliated to an Olympic federation
- Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.
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 |
|---|---|---|
| ExerciseMuscle induced-damage eccentric exercise | Other | Exercise |
Primary outcome
The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation
Time frame: Evolution of kinetics from Day 0 to Day 3 post experiment
Association between blood creatine kinase level variations and single nucleotide polymorphisms. The Outcome Measure in this study is focused on the variation in plasma CPK levels following an exercise inducing muscle damage. The result is expressed as a change in plasma CPK concentration, measured in units per liter (U/L). This single measurement is used to investigate its association with genetic polymorphisms. Therefore a regression analysis will be performed to identify the association. This study is exploratory and the genetic polymorphisms are not pre-identified but will be investigated through a comprehensive analysis.
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 9 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy, run by Lille University 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 9 Sep 2026. 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?
The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation (time frame: Evolution of kinetics from Day 0 to Day 3 post experiment). 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 9 Sep 2026.