Biological Consequences of an Ultra Endurance Race

Exertion; Excess Clinical Trial

— TRAIL-BIO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03194022
• Other study ID #: IDRCB : 2017-A01801-52
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: October 17, 2018

Study information

• Verified date: August 2018
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 17, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Exertion; Excess

Intervention

Other:
• Blood sample
measurement of electrolytes and blood count

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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