NCT05921864

Brief Summary

Military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. Induced heat stress can impair performance and lead to pathologies. Faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. While hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. The effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. What's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. A better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

June 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

June 16, 2023

Last Update Submit

September 7, 2023

Conditions

Keywords

ultra-endurance

Outcome Measures

Primary Outcomes (1)

  • Degree of correlation between core temperature measured at the end of passive heat exposure and that measured at the end of active heat exposure

    Core temperature will be measured in every participants at the end of passive heat exposure and at the end of active heat exposure. A correlation analysis will be performed on these measurements.

    Through study completion (1 month)

Interventions

Participants will be exposed to heat in a chamber.

Participants will participate to a 6-hour run.

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of healthy young athletes.

You may qualify if:

  • Healthy individuals
  • BMI between 18 and 25 kg/m2
  • Weight ≥ 51 kg
  • Minimum training volume 6 days/7, aerobic
  • Participation in a running competition ≥ 6hours
  • Having given informed consent

You may not qualify if:

  • Presence or history of medical pathology
  • Presence of significant deviation from normal electrocardiogram values
  • History of heat stroke
  • Known intolerance to heat
  • Inability to swallow a capsule or refusal of rectal probe
  • Alcohol consumption exceeding the equivalent of 3 glasses of wine per week
  • Consumption of narcotics
  • Smoking \> 0.5 pack of cigarettes per day
  • On usual medication
  • Pregnant or breast-feeding women
  • Protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 27, 2023

Study Start

June 19, 2023

Primary Completion

July 22, 2023

Study Completion

July 22, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations