Auxiliary Device to Alleviate Soldiers' Backload

Study Overview
=================
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.

Official Title
-----------------
Auxiliary Device to Alleviate Soldiers' Backload

Conditions
-----------------
Physiological Strain of Weight Bearing.

Intervention / Treatment
-----------------
* Device: Minkal- Auxiliary device to alleviate backload


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 28 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight bearing, physiological load