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

Physiology Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604339
• Other study ID #: 2022/CHU/18
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: April 30, 2023
• Est. primary completion date: October 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exanthema
• Physiology

Locations

Country	Name	City	State
Réunion	CHU de la Réunion	Saint-Denis

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	Aspetar Orthopedic and Sports Medicine Hospital, Universite de La Reunion, Université Jean Monnet-Saint-Etienne

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)