HealthyNCT01127191
Effect of Prolonged Military Exercises With High Load Carriage, on Neuromuscular Fatigue and Physiological/Biomechanical Responses
An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- military equipment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: military retreated from national army
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- military equipment
- Keywords
- military exercises, neuromuscular fatigue, physiological responses, biomechanical responses, simulated military effort, high load carriage, Healthy voluntary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
military equipmentOther
Military exercise of 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Military | Not described Receives: Other: military equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central fatigue quantification based on voluntary and electrically-induced force measurement on activated muscle.
Measured: after a a military exercise of 24 hours
Peripheral fatigue based on electrically-induced force measurement on the same muscle in relaxed condition.
Measured: 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.
Measured: after a a military exercise of 24 hours
Lactatemia, based on subject's arterialized capillary blood samples analysis
Measured: after a a military exercise of 24 hours
Muscular electrical activities, based on subject's surface EMG analysis
Measured: after a a military exercise of 24 hours
Heart rate frequence
Measured: after a a military exercise of 24 hours
Walking and running mechanics, measured by an instrumented treadmill
Measured: after a a military exercise of 24 hours
Postural equilibration, measured by a piezo-dynamometric double platform
Measured: after a a military exercise of 24 hours
Rate of perceived exertion, measured by the Borg scale ranging from 6 to 20
Measured: after a a military exercise of 24 hours
Perceived comfort, measured by a 10 cm visual analogic scale (VAS)
Measured: after a a military exercise of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger OULLION, Dr, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127191
- Sponsor's protocol ID
- 0901110
- Other IDs
- 2009-A01346-51
- Status last verified
- Jul 2012
- First submitted
- 11 May 2010
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22927995
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Military Exercises With High Load Carriage, on Neuromuscular Fatigue and Physiological/Biomechanical Responses
- ClinicalTrials.gov ID
- NCT01127191
- Acronym / sponsor ID
- 0901110
- Conditions
- Healthy
- Keywords
- military exercises, neuromuscular fatigue, physiological responses, biomechanical responses, simulated military effort, high load carriage, Healthy voluntary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Military | – | Other: military equipment |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- military retreated from national army
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| military equipmentMilitary exercise of 24 hours | Other | Military |
Primary outcome
Central fatigue quantification based on voluntary and electrically-induced force measurement on activated muscle.
Time frame: 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
8 secondary outcomes
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
Lactatemia, based on subject's arterialized capillary blood samples analysis
Time frame: 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
Heart rate frequence
Time frame: 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
Postural equilibration, measured by a piezo-dynamometric double platform
Time frame: 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
Perceived comfort, measured by a 10 cm visual analogic scale (VAS)
Time frame: after a a military exercise of 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Derived from this study: PubMed 22927995Grenier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger OULLION, Dr principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central fatigue quantification based on voluntary and electrically-induced force measurement on activated muscle. (time frame: after a a military exercise of 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.