Assessment of the Increased Risk of Infection Following an Ultratrail
INFultra
1 other identifier
interventional
471
1 country
1
Brief Summary
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence. The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedStudy Start
First participant enrolled
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2023
CompletedFebruary 17, 2026
February 1, 2026
1 month
August 11, 2023
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increased risk of infection
Comparing the incidence of all infectious symptoms in runners taking part in one of the Grand Raid races (exposed subjects) with the incidence of infectious symptoms in those accompanying them on the race. fever, congestion, stuffy nose, sneezing, shortness of breath, vomiting, diarrhea, headache, sore throat, general fatigue, burning and urinary symptoms, other infectious symptoms; associated with major infections (respiratory, skin, gastrointestinal, urinary, other)
Day 21
Secondary Outcomes (5)
Kinetic of infections' appearance
Day 21
Risk factors: running distance
Day 21
Risk factors: training volume
Day 21
Risk factors: sex of the runner
Day 21
Risk factors: age category
Day 21
Study Arms (2)
Exposed (Runners)
EXPERIMENTALUltra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km
Non-exposed (companions)
NO INTERVENTIONRunners' companions not running
Interventions
Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)
Eligibility Criteria
You may qualify if:
- \> 18 years
- Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
- Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
- Do not object to the research
You may not qualify if:
- Do not understand French
- A protected adult (guardianship or curatorship) or under court protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de la Réunionlead
- Jean Monnet Universitycollaborator
- Hôpital Privé de la Loire- Saint Etiennecollaborator
Study Sites (1)
CHU Réunion
Saint-Denis, 97400, Reunion
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas BOUSCAREN, MD
CHU de la Réunion
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
October 18, 2023
Study Start
October 6, 2023
Primary Completion
November 14, 2023
Study Completion
November 14, 2023
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share