Exertion; ExcessTRAIL-BIONCT03194022
Biological Consequences of an Ultra Endurance Race
An observational study of Exertion; Excess, run by Hôpital Necker-Enfants Malades.
Trial summary
The aim is to study per and post-exertion variations of biological markers during an ultra-endurance race Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exertion; Excess
- What is being tested?
- Blood sample
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 17 Oct 2018
- Phase
- Observational
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 healthy adult volunteers participating in the "100 miles South of France 2017 ©" race recruited electronically by an announcement on the race website
Who may be able to join
- Age greater 18 years.
- Subject having already completed an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
- Affiliation of a social security.
Who cannot join
- Age lower than 18 years
- Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or having a significant chronic inflammatory disease known at the time of the inclusion visit the day before the race.
- Female
About this study
Official title: Per Effort Study of Biological Consequences of an Ultra Endurance Race (165km)
The aim is to study per and post-exertion variations of biological markers during an ultra-endurance race
Read the detailed description
25 healthy adult volunteers participating in the "100 miles South of France 2017©" race recruited electronically by an announcement on the race website
- Conditions
- Exertion; Excess
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
measurement of electrolytes and blood count
What is being measured
The primary outcome is the main question the study is designed to answer.
Per and post-exertion evolution of sodium blood level
Change of sodium blood level during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of lactatemia
Change of lactatemia during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of myoglobin blood level
Change of myoglobin blood level will be measured during and after the race
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of creatinine phosphokinase blood level
Change of myoglobin blood level will be measured during and after the race
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of potassium blood level
Change of potassium blood level during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of chlorine blood level
Change of chlorine blood level during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of glucose blood level
Change of glucose blood level during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of calcium blood level
Change of calcium blood level during and after the race will be measured.
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion17 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exertion; ExcessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Jouffroy, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194022
- Sponsor's protocol ID
- IDRCB : 2017-A01801-52
- Acronym
- TRAIL-BIO
- Status last verified
- Aug 2018
- First submitted
- 16 Jun 2017
- Last updated
- 3 Aug 2018
- 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 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per Effort Study of Biological Consequences of an Ultra Endurance Race (165km)
- ClinicalTrials.gov ID
- NCT03194022
- Acronym / sponsor ID
- TRAIL-BIO / IDRCB : 2017-A01801-52
- Conditions
- Exertion; Excess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 17 Oct 2018 (estimated)
- First posted
- 21 Jun 2017 (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 aim is to study per and post-exertion variations of biological markers during an ultra-endurance race
Detailed description
25 healthy adult volunteers participating in the "100 miles South of France 2017©" race recruited electronically by an announcement on the race website
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 healthy adult volunteers participating in the "100 miles South of France 2017 ©" race recruited electronically by an announcement on the race website
Key inclusion criteria (3 listed)
- Age greater 18 years.
- Subject having already completed an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
- Affiliation of a social security.
Key exclusion criteria (3 listed)
- Age lower than 18 years
- Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or having a significant chronic inflammatory disease known at the time of the inclusion visit the day before the race.
- Female
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 |
|---|---|---|
| Blood samplemeasurement of electrolytes and blood count | Other | – |
Primary outcome
Per and post-exertion evolution of sodium blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of sodium blood level during and after the race will be measured.
Per and post-exertion evolution of lactatemia
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of lactatemia during and after the race will be measured.
Per and post-exertion evolution of myoglobin blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of myoglobin blood level will be measured during and after the race
Per and post-exertion evolution of creatinine phosphokinase blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of myoglobin blood level will be measured during and after the race
Per and post-exertion evolution of potassium blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of potassium blood level during and after the race will be measured.
Per and post-exertion evolution of chlorine blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of chlorine blood level during and after the race will be measured.
Per and post-exertion evolution of glucose blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of glucose blood level during and after the race will be measured.
Per and post-exertion evolution of calcium blood level
Time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Change of calcium blood level during and after the race will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Exertion; Excess, run by Hôpital Necker-Enfants Malades.
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 3 inclusion and 3 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Per and post-exertion evolution of sodium blood level (time frame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race). The study lists 8 primary outcomes in all. 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 3 Aug 2018.