NCT02498223

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

June 17, 2015

Last Update Submit

July 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • oxygen consumption

    oxygen consumption will be monitored continuously through the experimental days by a metabolic system (ERGOTEST 680, ZAN, GERMANY )

    3 experiment days

Secondary Outcomes (3)

  • Heart rate

    3 experiment days

  • pressure at the shoulders and the waist

    3 experiment days

  • walk analysis (composite)

    3 experiment days

Study Arms (1)

research arm

EXPERIMENTAL

50 subjects (healthy soldiers, male and female) from combat units will undergo the experiment protocol.

Other: experiment protocol

Interventions

the subjects will undergo the following experiment protocol: 1. recruitment and medical examination day. 2. 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. 3. 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.

research arm

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • the physician decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

Study Officials

  • Ofir Frenkel, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

July 15, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations