- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428779
Neuromuscular and Cognitive Fatigue During a 24 Hour Treadmill Running Exercise
June 10, 2009 updated by: Centre Hospitalier Universitaire de Saint Etienne
Neuromuscular and Cognitive Fatigue During a 24h Treadmill Running Exercise.
The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-etienne, France, 42055
- Pr André GEYSSANT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
patients running during 24 hours without sleep
|
patients running during 24 hours without sleep
|
Placebo Comparator: 2
patients without sleep during 24 hours
|
patients without sleep during 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
-Voluntary and electrically evoked forces on the contracted muscles
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electrically evoked forces on the relaxed muscles and associated EMG activity
Time Frame: 24 hours
|
24 hours
|
Blood samples before the exercise
Time Frame: every 4 hours
|
every 4 hours
|
Muscle biopsy (vastus lateralis)
Time Frame: before and after the exercise
|
before and after the exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: DENIS Christian, Professor, Service de médecine du sport, CHU SAINT-ETIENNE
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
January 29, 2007
First Submitted That Met QC Criteria
January 29, 2007
First Posted (Estimate)
January 30, 2007
Study Record Updates
Last Update Posted (Estimate)
June 11, 2009
Last Update Submitted That Met QC Criteria
June 10, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0601095
- DGS 2006-0111
- 2006-A00312-49
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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