Auxiliary Device to Alleviate Soldiers' Backload (minkal)

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.

Study Overview

• Status: Unknown
• Conditions: Physiological Strain of Weight Bearing.
• Intervention / Treatment: Device: "Minkal"- Auxiliary device to alleviate backload

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Institute of military physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 28 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Load with and without the auxiliary device	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.	6 days for each patient.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: July 4, 2011
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): March 29, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: weight bearing; physiological load
• Other Study ID Numbers: 963-2010-CLIL