NCT04136925

Brief Summary

Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat. In fact, thermoregulation has always been an integral part of exercise's physiology. Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels. Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems. The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

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

October 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 7, 2020

Status Verified

October 1, 2019

Enrollment Period

21 days

First QC Date

October 11, 2019

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Repercussion of the race on health evaluate by proportion of heat symptoms on our sample

    during the 3 days of the race

Study Arms (1)

runner participating of the "Grand Raid"

Other: questionnaire

Interventions

questionnaire before and after race

runner participating of the "Grand Raid"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Runners participating in one of the 3 individual races of the "Grand Raid" 2019 in Reunion Island

You may qualify if:

  • All major runners participating in one of the 3 individual races of the "Grand Raid" 2019 in Reunion Island

You may not qualify if:

  • Refusal to participate
  • Runners who do not understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97448, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nicolas BOUSCAREN

    Centre Hospitalier Universitaire de La REUNION

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 23, 2019

Study Start

October 11, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 7, 2020

Record last verified: 2019-10

Locations