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Auxiliary Device to Alleviate Soldiers' Backload (minkal)

This study is not yet open for participant recruitment.
Verified March 2012 by Medical Corps, Israel Defense Force
Sponsor:
Information provided by (Responsible Party):
amit druyan, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01565876
First received: July 4, 2011
Last updated: March 28, 2012
Last verified: March 2012
History of Changes

July 4, 2011
March 28, 2012
December 2012
December 2013   (final data collection date for primary outcome measure)
Physiological Load with and without the auxiliary device [ Time Frame: 6 days for each patient. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01565876 on ClinicalTrials.gov Archive Site
  • Rectal temperature [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    The Rectal temperature will be mesured by a rectal thermistore during each HTT.
  • Skin temperature [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm).
  • Heart Rate [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    Heart rate will be monitored using a polar watch.
  • Sweat Rate [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Sweat rate will be calculated from the patient's weight and his water balance.
Same as current
Not Provided
Not Provided
 
Auxiliary Device to Alleviate Soldiers' Backload
Auxiliary Device to Alleviate Soldiers' Backload

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Physiological Strain of Weight Bearing.
Device: "Minkal"- Auxiliary device to alleviate backload

The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.

Then The participants will undergo heat tolerance test 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 each day and compered afterwards.
Experimental: study

The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.

Then The participants will undergo heat tolerance test 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 each day and compered afterwards.

Intervention: Device: "Minkal"- Auxiliary device to alleviate backload
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Male
21 Years to 28 Years
Yes
Not Provided
Israel
 
NCT01565876
963-2010-CLIL
Not Provided
amit druyan, Medical Corps, Israel Defense Force
Medical Corps, Israel Defense Force
Not Provided
Principal Investigator: Chen Makernatz, MD Institute physician
Study Director: Yuval Heled, PhD Director of the military physiology institute, IDF medical corps
Study Director: Ran Yanovich, MA The director's deputy of the military physiology institute, IDF medical corps
Medical Corps, Israel Defense Force
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP