Physiological Strain of Weight Bearing. Clinical Trial
— minkalOfficial title:
Auxiliary Device to Alleviate Soldiers' Backload
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.
| Status | Not yet recruiting |
| Enrollment | 12 |
| Est. completion date | January 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 21 Years to 28 Years |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Israel | Institute of military physiology | Ramat Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Medical Corps, Israel Defense Force |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Secondary | Rectal temperature | The Rectal temperature will be mesured by a rectal thermistore during each HTT. | 6 days | Yes |
| Secondary | Skin temperature | The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm). | 6 days | No |
| Secondary | Heart Rate | Heart rate will be monitored using a polar watch. | 6 days | Yes |
| Secondary | Sweat Rate | Sweat rate will be calculated from the patient's weight and his water balance. | 6 days | No |