- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498223
Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity (LCI)
Study Overview
Detailed Description
50 healthy, male and female combat soldiers will be recruited. Anthropometry and maximal aerobic capacity will be measured for each participant: Physiological evaluation: the participants will perform physical stress on a treadmill with changing slope and speed, once carrying 40% of their body weight (as the current instructions) and a second time with weight that is calculated by the examined body composition and aerobic capacity based index (LCI). The physiological response will be assessed based on heart rate, lactic acid in the blood and oxygen consumption.
Biomechanical evaluation: the biomechanical response will be measured in the biomechanical lab: pressure on the shoulder and waist from the load and straps, walk analysis and stress scatter in the foot.
By this experiment the investigators want to examine if the new index, the LCI, is physiologically and biomechanically better than the current load distribution instructions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ramat- Gan
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Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-25 years.
- Healthy soldiers volunteers.
- Without heart, cardiovascular, metabolic or respiratory illnesses.
- Without known medical illness or medication use that might endanger the participants.
Exclusion Criteria:
- existence of any of undesired conditions detailed in the inclusion criteria.
- the physician decision.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: research arm
50 subjects (healthy soldiers, male and female) from combat units will undergo the experiment protocol.
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the subjects will undergo the following experiment protocol:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxygen consumption
Time Frame: 3 experiment days
|
oxygen consumption will be monitored continuously through the experimental days by a metabolic system (ERGOTEST 680, ZAN, GERMANY )
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3 experiment days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 3 experiment days
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The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
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3 experiment days
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pressure at the shoulders and the waist
Time Frame: 3 experiment days
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pressure sensors will monitor the pressure from the load (carried on the back)
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3 experiment days
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walk analysis (composite)
Time Frame: 3 experiment days
|
analysing subject's walk using the Zebris Medical system.
this system consist of a treadmill which is a FORCE PLATE that measure the forces between the treadmill and the shoe.
the outcomes are diagram of vertical forces and walk pattern.
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3 experiment days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-15-2156-OF-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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