- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01127191
Effect of Prolonged Military Exercises With High Load Carriage, on Neuromuscular Fatigue and Physiological/Biomechanical Responses
July 24, 2012 updated by: Centre Hospitalier Universitaire de Saint Etienne
Land military missions generally combine prolonged walking/moderate-pace-running and other physical actions such as creeping, jumping, shooting,… which are associated with the direct carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers.
For an infantry section, "typical" intervention phases last about 20-24 h and combine variable intensity grades.
Consequently, military mission characteristics are an interesting investigation field of human fatigue.
Previous studies have investigated human neuromuscular alterations after prolonged "normal" locomotion exercises [Millet et al., 2004, 2009], thus the aim of this study is to characterize the neuromuscular determinants of fatigue induced by a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed with high load carriage.
Additionally, the consequences of fatigue on physiological and biomechanical parameters of locomotion will be investigated.
Study Overview
Study Type
Observational
Enrollment (Actual)
10
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
-
-
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Saint-Etienne, France, 42055
- CHU de Saint-Etienne
-
-
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
30 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
military retreated from national army
Description
Inclusion Criteria:
- to be a male
- to have a VO2max > 45ml/min/kg (mean observed value in military subjects)
- to be aged from 30 to 45
- to be recently retreated from National Army
- to be highly experienced in military efforts
- to be trained in exercises involving load carrying
- to benefit from a social security insurance
Exclusion Criteria:
- All subjects with recent (< 3 month) bone, articular or muscle diseases.
- All subjects presenting a clinic sign of intolerance to testing procedures, especially subjects with knee, ankle, hip or back diseases.
- All subjects intolerant to muddy or wooded environment.
- All subjects presenting a clinic sign of intolerance to exercise, and particularly to running or walking while carrying a load
- All subjects involved at the same time in another medical research
- All subjects militarily active
- All subjects with cardiac or pulmonary identified and known diseases
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Military
|
Military exercise of 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Central fatigue quantification based on voluntary and electrically-induced force measurement on activated muscle.
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Peripheral fatigue based on electrically-induced force measurement on the same muscle in relaxed condition.
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oxygen uptake, carbon-dioxide output, energetic-cost of locomotion and respiratory ratio, based on subject's gas exchanges.
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Lactatemia, based on subject's arterialized capillary blood samples analysis
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Muscular electrical activities, based on subject's surface EMG analysis
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Heart rate frequence
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Walking and running mechanics, measured by an instrumented treadmill
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Postural equilibration, measured by a piezo-dynamometric double platform
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Rate of perceived exertion, measured by the Borg scale ranging from 6 to 20
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
|
Perceived comfort, measured by a 10 cm visual analogic scale (VAS)
Time Frame: after a a military exercise of 24 hours
|
after a a military exercise of 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roger OULLION, Dr, 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.
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
March 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
May 11, 2010
First Submitted That Met QC Criteria
May 19, 2010
First Posted (Estimate)
May 20, 2010
Study Record Updates
Last Update Posted (Estimate)
July 25, 2012
Last Update Submitted That Met QC Criteria
July 24, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0901110
- 2009-A01346-51 (Other Identifier: AFSSAPS)
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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