Clinical trial NCT05604339: Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners (ERUPTION-3)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physiology
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
name: Aspetar Orthopedic and Sports Medicine Hospital
name: Universite de La Reunion
First posted: 2022-11-03
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* \>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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Recovery and its kinetics in the aftermath of an ultratrail run in a tropical environment.
timeFrame: 3 Months
measure: Recovery and its kinetics in the musculo-articular evaluations in the aftermath of an ultratrail run in a tropical environment.
timeFrame: 3 Months
measure: Recovery and its kinetics of sleep in the aftermath of an ultratrail run in a tropical environment.
timeFrame: 3 Months
measure: Recovery and its kinetics of tiredness in the aftermath of an ultratrail run in a tropical environment.
timeFrame: 3 Months
measure: Recovery and its kinetics of injury in the aftermath of an ultratrail run in a tropical environment.
timeFrame: 6 Months
measure: To evaluate recovery and its kinetics in its different dimensions in ultra-endurance runners
timeFrame: 1 Month
measure: Ancillary Study: Change in Hematological Recovery biomarkers
timeFrame: Day 2, Day 5, Day 9 and Day 16
measure: Ancillary Study: Change in Muscular Recovery biomarkers
timeFrame: Day 2, Day 5, Day 9 and Day 16
measure: Ancillary Study: Change in Inflammatory Recovery biomarkers
timeFrame: Day 2, Day 5, Day 9 and Day 16
measure: Ancillary Study: Change in Hepatic Recovery biomarkers
timeFrame: Day 2, Day 5, Day 9 and Day 16
measure: Ancillary Study: Blood rheologic properties and the senescence of red blood cells
timeFrame: Post-race (between day2 and day4 depending on the time of race arrival)
measure: Ancillary Study: Senescence of red blood cells
timeFrame: Post-race (between day2 and day4 depending on the time of race arrival)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
Study officials:
affiliation: CHU La Réunion
name: Nicolas BOUSCAREN
role: PRINCIPAL_INVESTIGATOR
References: