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Clinical Trials/NCT01565876
NCT01565876
Unknown
Not Applicable

Auxiliary Device to Alleviate Soldiers' Backload

Medical Corps, Israel Defense Force1 site in 1 country12 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physiological Strain of Weight Bearing.
Sponsor
Medical Corps, Israel Defense Force
Enrollment
12
Locations
1
Primary Endpoint
Physiological Load with and without the auxiliary device
Last Updated
14 years ago

Overview

Brief Summary

Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.

The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
January 2014
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Medical Corps, Israel Defense Force
Responsible Party
Principal Investigator
Principal Investigator

amit druyan

The Institute of Military Physiology

Medical Corps, Israel Defense Force

Eligibility Criteria

Inclusion Criteria

  • Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
  • Lack of any acute disease during 2 weeks prior the study.
  • Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.

Exclusion Criteria

  • Rectal temperature above 39 Celsius degrees.
  • HR above maximal HR ( calculated as 220-age)
  • The subject's will to stop the test.
  • The researcher's/doctor's judgment.

Outcomes

Primary Outcomes

Physiological Load with and without the auxiliary device

Time Frame: 6 days for each patient.

The physiological load will be measured using a heat tolerance test(HTT). Each paricipant will undergo a HTT 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured in each HTT and compered afterwards to assess the physiological load.

Secondary Outcomes

  • Rectal temperature(6 days)
  • Skin temperature(6 days)
  • Heart Rate(6 days)
  • Sweat Rate(6 days)

Study Sites (1)

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