Auxiliary Device to Alleviate Soldiers' Backload

NCT ID: NCT01565876

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physiological Strain of Weight Bearing.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

"Minkal"- Auxiliary device to alleviate backload

Intervention Type DEVICE

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.

Interventions

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"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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

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amit druyan

The Institute of Military Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen Makernatz, MD

Role: PRINCIPAL_INVESTIGATOR

Institute physician

Yuval Heled, PhD

Role: STUDY_DIRECTOR

Director of the military physiology institute, IDF medical corps

Ran Yanovich, MA

Role: STUDY_DIRECTOR

The director's deputy of the military physiology institute, IDF medical corps

Locations

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Institute of military physiology

Ramat Gan, , Israel

Site Status

Countries

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Israel

Facility Contacts

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Yuval Heled, PhD

Role: primary

+972-3-7376584

Other Identifiers

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963-2010-CLIL

Identifier Type: -

Identifier Source: org_study_id

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