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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06089174
Other study ID # 2023/CHU/23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date December 2023

Study information

Verified date October 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact Simon BOSSIS
Phone 04 77 42 17 00
Email infection.postultratrail@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1300
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 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 Exclusion Criteria: - Do not understand French - A protected adult (guardianship or curatorship) or under court protection

Study Design


Intervention

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

Locations

Country Name City State
Réunion CHU Réunion Saint-Denis

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion Hôpital Privé de la Loire- Saint Etienne, Université Jean Monnet-Saint-Etienne

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Kinetic of infections' appearance Kinetics of the onset of infectious symptoms within 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects) and their companions (unexposed subjects). Survival curves over the 3 weeks post-race will be produced.
An on-line questionnaire will be used to collect infectious data.
Day 21
Secondary Risk factors: running distance Identify if the distance of the race in which the runner participates is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
An on-line questionnaire will be used to collect data related to the race distance.
Day 21
Secondary Risk factors: training volume Identify if the runner's training volume is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects). Day 21
Secondary Risk factors: sex of the runner Identify if sex of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects). Day 21
Secondary Risk factors: age category Identify if the age of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects). Day 21
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