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Auxiliary Device to Alleviate Soldiers' Backload (minkal)

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ClinicalTrials.gov Identifier: NCT01565876
Recruitment Status : Unknown
Verified March 2012 by amit druyan, Medical Corps, Israel Defense Force.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Physiological Strain of Weight Bearing. Device: "Minkal"- Auxiliary device to alleviate backload

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Auxiliary Device to Alleviate Soldiers' Backload
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014
Arms and Interventions

Arm Intervention/treatment
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.

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.



Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rectal temperature [ Time Frame: 6 days ]
    The Rectal temperature will be mesured by a rectal thermistore during each HTT.

  2. Skin temperature [ Time Frame: 6 days ]
    The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm).

  3. Heart Rate [ Time Frame: 6 days ]
    Heart rate will be monitored using a polar watch.

  4. Sweat Rate [ Time Frame: 6 days ]
    Sweat rate will be calculated from the patient's weight and his water balance.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565876


Locations
Israel
Institute of military physiology Not yet recruiting
Ramat Gan, Israel
Contact: Yuval Heled, PhD    +972-3-7376584      
Principal Investigator: Chen Makernatz, MD         
Sub-Investigator: Yuval Heled, PhD         
Sub-Investigator: Ran Yanovich, MA         
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
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
More Information

Responsible Party: amit druyan, The Institute of Military Physiology, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01565876     History of Changes
Other Study ID Numbers: 963-2010-CLIL
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by amit druyan, Medical Corps, Israel Defense Force:
weight bearing
physiological load