- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05604339
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Denis, Réunion, 97400
- CHU de la réunion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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 |
|---|---|---|
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Recovery and its kinetics in the aftermath of an ultratrail run in a tropical environment.
Time Frame: 3 Months
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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
|
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Recovery and its kinetics in the musculo-articular evaluations in the aftermath of an ultratrail run in a tropical environment.
Time Frame: 3 Months
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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
|
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Recovery and its kinetics of sleep in the aftermath of an ultratrail run in a tropical environment.
Time Frame: 3 Months
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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
|
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Recovery and its kinetics of tiredness in the aftermath of an ultratrail run in a tropical environment.
Time Frame: 3 Months
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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
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Recovery and its kinetics of injury in the aftermath of an ultratrail run in a tropical environment.
Time Frame: 6 Months
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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
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To evaluate recovery and its kinetics in its different dimensions in ultra-endurance runners
Time Frame: 1 Month
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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
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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)
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Evaluate the rheologic biomarkers by measuring the blood viscosity directly after the race in comparison with measurements taken before the race
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Post-race (between day2 and day4 depending on the time of race arrival)
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Ancillary Study: Senescence of red blood cells
Time Frame: Post-race (between day2 and day4 depending on the time of race arrival)
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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
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Post-race (between day2 and day4 depending on the time of race arrival)
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Ancillary Study: Change in Hematological Recovery biomarkers
Time Frame: Day 2, Day 5, Day 9 and Day 16
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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
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Day 2, Day 5, Day 9 and Day 16
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Ancillary Study: Change in Muscular Recovery biomarkers
Time Frame: Day 2, Day 5, Day 9 and Day 16
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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
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Day 2, Day 5, Day 9 and Day 16
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Ancillary Study: Change in Inflammatory Recovery biomarkers
Time Frame: Day 2, Day 5, Day 9 and Day 16
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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
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Day 2, Day 5, Day 9 and Day 16
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Ancillary Study: Change in Hepatic Recovery biomarkers
Time Frame: Day 2, Day 5, Day 9 and Day 16
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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
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Day 2, Day 5, Day 9 and Day 16
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicolas BOUSCAREN, CHU La Réunion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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