Auxiliary Device to Alleviate Soldiers' Backload (minkal)
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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 |
- 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.
- 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 |
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| 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 | |
| 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 May 22, 2013