NCT06089174

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

87
On Track

Trial Health Score

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

Enrollment
471

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

August 11, 2023

Last Update Submit

February 16, 2026

Conditions

Keywords

Immune deficiencyUltra-runningInfection

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)

EXPERIMENTAL

Ultra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km

Other: Ultra-trail

Non-exposed (companions)

NO INTERVENTION

Runners' companions not running

Interventions

Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)

Exposed (Runners)

Eligibility Criteria

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

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

Study Sites (1)

CHU Réunion

Saint-Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Immunologic Deficiency SyndromesInfections

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Nicolas BOUSCAREN, MD

    CHU de la Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This study is a descriptive cohort study comparing the occurrence of infection between exposed (runners of an ultra-trail) and unexposed subjects (their companions).
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

Locations