Auxiliary Device to Alleviate Soldiers' Backload

Not Applicable

• Conditions: Physiological Strain of Weight Bearing.

• Registration Number: NCT01565876
• Lead Sponsor: Medical Corps, Israel Defense Force

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-04
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-28
• Last Update Submitted: 2012-03-28
• Study First Posted: 2012-03-29
• Last Update Posted: 2012-03-29
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Physiological Load with and without the auxiliary device	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 Outcome Measures

Name	Time	Method
Rectal temperature	6 days	The Rectal temperature will be mesured by a rectal thermistore during each HTT.
Skin temperature	6 days	The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm).
Heart Rate	6 days	Heart rate will be monitored using a polar watch.
Sweat Rate	6 days	Sweat rate will be calculated from the patient's weight and his water balance.

Trial Locations

Locations (1)

Institute of military physiology; 🇮🇱 Ramat Gan, Israel