Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity

Work Load Clinical Trial

— LCI  

Official title:

Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02498223
• Other study ID #: SHEBA-15-2156-OF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: July 12, 2015
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

In order to reduce the physiological and biomechanical loads that the soldiers are exposed to, the investigators want to examine new approaches for distributing the carried loads according to measurements that are specific for each soldier (body composition and aerobic capacity). A functional index (LCI=load carriage index) will provide the commander a tool for better decisions in distributing the same total load among the same number of soldiers, according to each soldier's ability.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Work Load

Intervention

Other:
• experiment protocol
the subjects will undergo the following experiment protocol: recruitment and medical examination day. physiological evaluation day- the subjects will perform twice* a physiological stress protocol ; 3 min sitting followed by 20 min walking on treadmill (4 km/h, 4% slope), and then 3 min sitting for recovery examination. total 26 min. biomechanical valuation day- the subjects will perform twice* a biomechanical protocol using the Zebris system; 2 min standing followed by 10 min walking on treadmill (4 km/h, 4% slope). total 12 min. once carrying the weight calculated according to the army current instructions, and a second time carrying weight calculated according to the new LCI. 2 hours rest between the two performances.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen consumption	oxygen consumption will be monitored continuously through the experimental days by a metabolic system (ERGOTEST 680, ZAN, GERMANY )	3 experiment days	No
Secondary	Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	3 experiment days	Yes
Secondary	pressure at the shoulders and the waist	pressure sensors will monitor the pressure from the load (carried on the back)	3 experiment days	No
Secondary	walk analysis (composite)	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.	3 experiment days	No