Biological Consequences of an Ultra Endurance Race (TRAIL-BIO)

Per Effort Study of Biological Consequences of an Ultra Endurance Race (165km)

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

Study Overview

• Status: Unknown
• Conditions: Exertion; Excess
• Intervention / Treatment: Other: Blood sample

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

• Study Type: Observational
• Enrollment (Anticipated): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per and post-exertion evolution of sodium blood level	Change of sodium blood level during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of lactatemia	Change of lactatemia during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of myoglobin blood level	Change of myoglobin blood level will be measured during and after the race	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of creatinine phosphokinase blood level	Change of myoglobin blood level will be measured during and after the race	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of potassium blood level	Change of potassium blood level during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of chlorine blood level	Change of chlorine blood level during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of glucose blood level	Change of glucose blood level during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Per and post-exertion evolution of calcium blood level	Change of calcium blood level during and after the race will be measured.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): October 17, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (ACTUAL): June 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IDRCB : 2017-A01801-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No