NCT05604339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
562

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

October 3, 2022

Last Update Submit

August 11, 2023

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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

    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)

    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)

    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)

    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)

    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)

    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

    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

    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

    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

    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

    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

    Post-race (between day2 and day4 depending on the time of race arrival)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \>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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location

Study Officials

  • Nicolas BOUSCAREN

    CHU La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

November 3, 2022

Study Start

September 20, 2022

Primary Completion

October 23, 2022

Study Completion

April 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations