NCT01127191

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

May 11, 2010

Last Update Submit

July 24, 2012

Conditions

Keywords

military exercisesneuromuscular fatiguephysiological responsesbiomechanical responsessimulated military efforthigh load carriageHealthy voluntary

Outcome Measures

Primary Outcomes (2)

  • Central fatigue quantification based on voluntary and electrically-induced force measurement on activated muscle.

    after a a military exercise of 24 hours

  • Peripheral fatigue based on electrically-induced force measurement on the same muscle in relaxed condition.

    after a a military exercise of 24 hours

Secondary Outcomes (8)

  • Oxygen uptake, carbon-dioxide output, energetic-cost of locomotion and respiratory ratio, based on subject's gas exchanges.

    after a a military exercise of 24 hours

  • Lactatemia, based on subject's arterialized capillary blood samples analysis

    after a a military exercise of 24 hours

  • Muscular electrical activities, based on subject's surface EMG analysis

    after a a military exercise of 24 hours

  • Heart rate frequence

    after a a military exercise of 24 hours

  • Walking and running mechanics, measured by an instrumented treadmill

    after a a military exercise of 24 hours

  • +3 more secondary outcomes

Study Arms (1)

Military

Other: military equipment

Interventions

Military exercise of 24 hours

Military

Eligibility Criteria

Age30 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

military retreated from national army

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Grenier JG, Millet GY, Peyrot N, Samozino P, Oullion R, Messonnier L, Morin JB. Effects of extreme-duration heavy load carriage on neuromuscular function and locomotion: a military-based study. PLoS One. 2012;7(8):e43586. doi: 10.1371/journal.pone.0043586. Epub 2012 Aug 22.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lactatemia, based on subject's arterialized capillary blood samples analysis.

Study Officials

  • Roger OULLION, Dr

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 20, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations