## Protocol Section
### Identification Module
**NCT ID:** NCT00428779

**Brief Title:** Neuromuscular and Cognitive Fatigue During a 24 Hour Treadmill Running Exercise

**Official Title:** Neuromuscular and Cognitive Fatigue During a 24h Treadmill Running Exercise.

#### Organization Study ID Info
**ID:** 0601095
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Saint Etienne
#### Secondary ID Infos
**ID:** DGS 2006-0111
**ID:** 2006-A00312-49
### Status Module
#### Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-06-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-06-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Start Date
**Date:** 2007-09

**Status Verified Date:** 2009-06

#### Study First Post Date
**Date:** 2007-01-30
**Type:** ESTIMATED
**Study First Submit Date:** 2007-01-29
**Study First Submit QC Date:** 2007-01-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Saint Etienne

#### Responsible Party

**Old Name Title:** Clément CAILLAUX

**Old Organization:** CHU de Saint-Etienne

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.

**Detailed Description:** For that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control group being awake during the same period. Subjects who running will have electrically evoked forces on the muscles associated EMG activity, blood samples and muscle biopsy.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Running during 24 hours

- Voluntary evoked force on the muscles

- Electrically evoked force on the muscles

- EMG activity

- Muscle biopsy

- subjects will be recruited among experienced ultra-runners

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients running during 24 hours without sleep

**Intervention Names:**

- Procedure: running during 24 hours without sleep

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** patients without sleep during 24 hours

**Intervention Names:**

- Other: no sleeping

**Label:** 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** patients running during 24 hours without sleep

**Name:** running during 24 hours without sleep

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** patients without sleep during 24 hours

**Name:** no sleeping

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** -Voluntary and electrically evoked forces on the contracted muscles

**Time Frame:** 24 hours

#### Secondary Outcomes

**Measure:** Electrically evoked forces on the relaxed muscles and associated EMG activity

**Time Frame:** 24 hours

**Measure:** Blood samples before the exercise

**Time Frame:** every 4 hours

**Measure:** Muscle biopsy (vastus lateralis)

**Time Frame:** before and after the exercise

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The subjects of the experimental group will be recruited among experienced ultra-runners . They all have run at least a 12 hour race or longer.
* The control group will be recruited among experienced ultra-runners . Age of control group will be age experimental group more or less 2 years.

Exclusion Criteria:

* The subjects will not be selected if:

  * they were injured in the 3 months before the experiment
  * they had a tendon or joint pathology that could impair strength measurements.
  * they participate to an other experiment at the same time

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saint-etienne

**Country:** France

**Facility:** Pr André GEYSSANT

**Zip:** 42055

#### Overall Officials

**Official 1:**

**Affiliation:** Service de médecine du sport, CHU SAINT-ETIENNE

**Name:** DENIS Christian, Professor

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Morin JB, Samozino P, Feasson L, Geyssant A, Millet G. Effects of muscular biopsy on the mechanics of running. Eur J Appl Physiol. 2009 Jan;105(2):185-90. doi: 10.1007/s00421-008-0888-2. Epub 2008 Oct 8.

**PMID:** 18841378

**Citation:** Jamart C, Francaux M, Millet GY, Deldicque L, Frere D, Feasson L. Modulation of autophagy and ubiquitin-proteasome pathways during ultra-endurance running. J Appl Physiol (1985). 2012 May;112(9):1529-37. doi: 10.1152/japplphysiol.00952.2011. Epub 2012 Feb 16.

**PMID:** 22345427

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

### Condition Browse Module - Meshes

- ID: D000005221

- Term: Fatigue

### Misc Info Module

- Version Holder: 2024-05-24
