Clinical trial NCT03194022: Biological Consequences of an Ultra Endurance Race
Official title: Per Effort Study of Biological Consequences of an Ultra Endurance Race (165km)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exertion; Excess
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 healthy adult volunteers participating in the "100 miles South of France 2017 ©" race recruited electronically by an announcement on the race website

Brief summary: The aim is to study per and post-exertion variations of biological markers during an ultra-endurance race

Detailed description: 25 healthy adult volunteers participating in the "100 miles South of France 2017©" race recruited electronically by an announcement on the race website

Eligibility criteria: Inclusion Criteria:

1. Age greater 18 years.
2. Subject having already completed an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
3. Affiliation of a social security.

Exclusion Criteria:

1. Age lower than 18 years
2. Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or having a significant chronic inflammatory disease known at the time of the inclusion visit the day before the race.
3. Female

Primary outcomes:
measure: Per and post-exertion evolution of sodium blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of lactatemia
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of myoglobin blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of creatinine phosphokinase blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of potassium blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of chlorine blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of glucose blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertion evolution of calcium blood level
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: