Auxiliary Device to Alleviate Soldiers' Backload (minkal)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Medical Corps, Israel Defense Force.
Recruitment status was  Not yet recruiting
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
  Purpose

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 Intervention
Physiological Strain of Weight Bearing.
Device: "Minkal"- Auxiliary device to alleviate backload

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Auxiliary Device to Alleviate Soldiers' Backload

Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   21 Years to 28 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 4, 2011
Last Updated: March 28, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on October 01, 2014