PhysiologyERUPTION-3NCT05604339
Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners (ERUPTION-3)
An observational study of Physiology, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
While the acute consequences of an ultratrail are beginning to be well documented, data on the study of recovery in the aftermath of an event are much rarer. In order to overcome these various limitations, the main study of the ERUPTION-3 project is set up on the Grand Raid de La Réunion 2022 races. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physiology
- How many people
- 562 participants
- Where
- 1 siteReunion
- Study dates
- 20 Sep 2022to 30 Apr 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the main study, the recruitement of 1300 participants within the 6500 runners of the Grand Raid is planned. Call for volonteers will be made via the association organising the race. For the ancillary study, among these 1300 participants, 90 will be choosen (30 of each race, Diagonale des Fous, Trail de Bourbon and Mascareignes) to participate to this optional study.
Who may be able to join
- >18 years
- Participating in the Grand Raid de la Réunion race (Mascareignes, Trail de Bourbon or Diagonale des fous)
- Affiliated or beneficiary of a social security scheme
- Not opposed to the research for the main study
- Having given their written consent for the participants of the ancillary study
Who cannot join
- Not understanding French
- Protected adult (guardianship or curatorship) or under court protection
- Who have difficulty swallowing paracetamol capsules and for whom it will therefore be difficult to swallow the e-Celsius® Performance capsules (for the ancillary study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la récupération et Des Modifications de la rhéologie Sanguine Chez Les Coureurs d'Ultraendurance ERUPTION-3 / Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners ERUPTION-3
While the acute consequences of an ultratrail are beginning to be well documented, data on the study of recovery in the aftermath of an event are much rarer.
In order to overcome these various limitations, the main study of the ERUPTION-3 project is set up on the Grand Raid de La Réunion 2022 races.
Read more
In the context of exercise responses, the rheological properties of blood can impact the endurance performance. In contrast to short-distance events, the study of blood rheology and red blood cells integrity in long-distance events such as ultra-endurance races is poorly documented in the literature.
In the ancillary study, the work that is intended to be carried y out will complement the initial results found by a previous research on 23 runners during the Ultra Trail du Mont Blanc. This ancillary study will also be an opportunity to complete the data from the main study by studying the kinetics of biomarker recovery.
- Conditions
- Physiology
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery and its kinetics in the aftermath of an ultratrail run in a tropical environment.
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment:
- Hooper Index (4 questions: sleep, stress, tiredness and muscular pain) each ranging from 1 to 7 with 1 being very good ranking and 7 worse ranking
Measured: 3 Months
Recovery and its kinetics in the musculo-articular evaluations in the aftermath of an ultratrail run in a tropical environment.
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment:
- musculo-articular recovery (descriptive assessment no score)
Measured: 3 Months
Recovery and its kinetics of sleep in the aftermath of an ultratrail run in a tropical environment.
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment:
- sleep questionnaire (descriptive assessment no score)
Measured: 3 Months
Recovery and its kinetics of tiredness in the aftermath of an ultratrail run in a tropical environment.
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment:
- tiredness questionnaire (descriptive assessment no score)
Measured: 3 Months
Recovery and its kinetics of injury in the aftermath of an ultratrail run in a tropical environment.
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment:
- injury questionnaire (descriptive assessment no score)
Measured: 6 Months
To evaluate recovery and its kinetics in its different dimensions in ultra-endurance runners
Evaluate by means of objective evaluations in the aftermath of an ultratrail run in a tropical environment:
1200m and 400m test (best race time)
Measured: 1 Month
Ancillary Study: Change in Hematological Recovery biomarkers
Evaluate the changes in recovery kinetics of biological markers (hematological:haemoglobin in g/dL ) directly after the race in comparison with measurements taken before the race
Measured: Day 2, Day 5, Day 9 and Day 16
Ancillary Study: Change in Muscular Recovery biomarkers
Evaluate the changes in recovery kinetics of biological markers (muscular: Creatin PhosphoKinase in UI/L), directly after the race in comparison with measurements taken before the race
Measured: Day 2, Day 5, Day 9 and Day 16
Ancillary Study: Change in Inflammatory Recovery biomarkers
Evaluate the changes in recovery kinetics of biological markers (inflammatory: Protein C-reactive in mg/L) directly after the race in comparison with measurements taken before the race
Measured: Day 2, Day 5, Day 9 and Day 16
Ancillary Study: Change in Hepatic Recovery biomarkers
Evaluate the changes in recovery kinetics of biological markers (hepatic: ASAT \& ALAT in UI/L) directly after the race in comparison with measurements taken before the race
Measured: Day 2, Day 5, Day 9 and Day 16
Ancillary Study: Blood rheologic properties and the senescence of red blood cells
Evaluate the rheologic biomarkers by measuring the blood viscosity directly after the race in comparison with measurements taken before the race
Measured: Post-race (between day2 and day4 depending on the time of race arrival)
Ancillary Study: Senescence of red blood cells
Evaluate the Senescence of red blood cells directly after the race in comparison to before the race, by taking blood samples and analysing them using spectrophotometry and fluorescent-activated cells sorting
Measured: Post-race (between day2 and day4 depending on the time of race arrival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start20 Sep 2022
- Primary completion23 Oct 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiologyStudies 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
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University, Aspetar Orthopedic and Sports Medicine Hospital, Universite de La Reunion
- Responsible party
- Sponsor
- Investigators
- Nicolas BOUSCAREN, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604339
- Sponsor's protocol ID
- 2022/CHU/18
- Acronym
- ERUPTION-3
- Status last verified
- Aug 2023
- First submitted
- 3 Oct 2022
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la récupération et Des Modifications de la rhéologie Sanguine Chez Les Coureurs d'Ultraendurance ERUPTION-3 / Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners ERUPTION-3
- ClinicalTrials.gov ID
- NCT05604339
- Acronym / sponsor ID
- ERUPTION-3 / 2022/CHU/18
- Conditions
- Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Jean Monnet University, Aspetar Orthopedic and Sports Medicine Hospital, Universite de La Reunion
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Nov 2022 (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.
While the acute consequences of an ultratrail are beginning to be well documented, data on the study of recovery in the aftermath of an event are much rarer.
In order to overcome these various limitations, the main study of the ERUPTION-3 project is set up on the Grand Raid de La Réunion 2022 races.
In the context of exercise responses, the rheological properties of blood can impact the endurance performance. In contrast to short-distance events, the study of blood rheology and red blood cells integrity in long-distance events such as ultra-endurance races is poorly documented in the literature.
In the ancillary study, the work that is intended to be carried y out will complement the initial results found by a previous research on 23 runners during the Ultra Trail du Mont Blanc. This ancillary study will also be an opportunity to complete the data from the main study by studying the kinetics of biomarker recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the main study, the recruitement of 1300 participants within the 6500 runners of the Grand Raid is planned. Call for volonteers will be made via the association organising the race. For the ancillary study, among these 1300 participants, 90 will be choosen (30 of each race, Diagonale des Fous, Trail de Bourbon and Mascareignes) to participate to this optional study.
Key inclusion criteria (5 listed)
- >18 years
- Participating in the Grand Raid de la Réunion race (Mascareignes, Trail de Bourbon or Diagonale des fous)
- Affiliated or beneficiary of a social security scheme
- Not opposed to the research for the main study
- Having given their written consent for the participants of the ancillary study
Key exclusion criteria (3 listed)
- Not understanding French
- Protected adult (guardianship or curatorship) or under court protection
- Who have difficulty swallowing paracetamol capsules and for whom it will therefore be difficult to swallow the e-Celsius® Performance capsules (for the ancillary study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery and its kinetics in the aftermath of an ultratrail run in a tropical environment.
Time frame: 3 Months
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment: - Hooper Index (4 questions: sleep, stress, tiredness and muscular pain) each ranging from 1 to 7 with 1 being very good ranking and 7 worse ranking
Recovery and its kinetics in the musculo-articular evaluations in the aftermath of an ultratrail run in a tropical environment.
Time frame: 3 Months
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment: - musculo-articular recovery (descriptive assessment no score)
Recovery and its kinetics of sleep in the aftermath of an ultratrail run in a tropical environment.
Time frame: 3 Months
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment: - sleep questionnaire (descriptive assessment no score)
Recovery and its kinetics of tiredness in the aftermath of an ultratrail run in a tropical environment.
Time frame: 3 Months
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment: - tiredness questionnaire (descriptive assessment no score)
Recovery and its kinetics of injury in the aftermath of an ultratrail run in a tropical environment.
Time frame: 6 Months
Evaluate by means of subjective evaluations in the aftermath of an ultratrail run in a tropical environment: - injury questionnaire (descriptive assessment no score)
To evaluate recovery and its kinetics in its different dimensions in ultra-endurance runners
Time frame: 1 Month
Evaluate by means of objective evaluations in the aftermath of an ultratrail run in a tropical environment: 1200m and 400m test (best race time)
Ancillary Study: Change in Hematological Recovery biomarkers
Time frame: Day 2, Day 5, Day 9 and Day 16
Evaluate the changes in recovery kinetics of biological markers (hematological:haemoglobin in g/dL ) directly after the race in comparison with measurements taken before the race
Ancillary Study: Change in Muscular Recovery biomarkers
Time frame: Day 2, Day 5, Day 9 and Day 16
Evaluate the changes in recovery kinetics of biological markers (muscular: Creatin PhosphoKinase in UI/L), directly after the race in comparison with measurements taken before the race
Ancillary Study: Change in Inflammatory Recovery biomarkers
Time frame: Day 2, Day 5, Day 9 and Day 16
Evaluate the changes in recovery kinetics of biological markers (inflammatory: Protein C-reactive in mg/L) directly after the race in comparison with measurements taken before the race
Ancillary Study: Change in Hepatic Recovery biomarkers
Time frame: Day 2, Day 5, Day 9 and Day 16
Evaluate the changes in recovery kinetics of biological markers (hepatic: ASAT \& ALAT in UI/L) directly after the race in comparison with measurements taken before the race
Ancillary Study: Blood rheologic properties and the senescence of red blood cells
Time frame: Post-race (between day2 and day4 depending on the time of race arrival)
Evaluate the rheologic biomarkers by measuring the blood viscosity directly after the race in comparison with measurements taken before the race
Ancillary Study: Senescence of red blood cells
Time frame: Post-race (between day2 and day4 depending on the time of race arrival)
Evaluate the Senescence of red blood cells directly after the race in comparison to before the race, by taking blood samples and analysing them using spectrophotometry and fluorescent-activated cells sorting
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 14 Aug 2023.
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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.
Nicolas BOUSCAREN principal investigator
CHU La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiology, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 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: finished, as of the sponsor's last update on 14 Aug 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 Reunion. 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?
Recovery and its kinetics in the aftermath of an ultratrail run in a tropical environment. (time frame: 3 Months). The study lists 12 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 14 Aug 2023.