Study of Recovery and Blood Rheology Changes in Ultra-endurance Runners (ERUPTION-3) (ERUPTION-3)

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.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

562

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Denis, Réunion, 97400
        • CHU de la réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

3 Months
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)

3 Months
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)

3 Months
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)

3 Months
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)

6 Months
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)

1 Month
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
Post-race (between day2 and day4 depending on the time of race arrival)
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
Post-race (between day2 and day4 depending on the time of race arrival)
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
Day 2, Day 5, Day 9 and Day 16
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
Day 2, Day 5, Day 9 and Day 16
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
Day 2, Day 5, Day 9 and Day 16
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
Day 2, Day 5, Day 9 and Day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Actual)

October 23, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/CHU/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physiology

Subscribe