Work LoadLCINCT02498223
Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity
A study testing experiment protocol in people with Work Load, run by Sheba Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Load
- What is being tested?
- experiment protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- existence of any of undesired conditions detailed in the inclusion criteria.
- the physician decision.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Work Load
- Being tested
- experiment protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experiment protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | 50 subjects (healthy soldiers, male and female) from combat units will undergo the experiment protocol. Receives: Other: experiment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption
oxygen consumption will be monitored continuously through the experimental days by a metabolic system (ERGOTEST 680, ZAN, GERMANY )
Measured: 3 experiment days
Secondary outcomes (3)
Heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 3 experiment days
pressure at the shoulders and the waist
pressure sensors will monitor the pressure from the load (carried on the back)
Measured: 3 experiment days
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.
Measured: 3 experiment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work LoadStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofir Frenkel, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498223
- Sponsor's protocol ID
- SHEBA-15-2156-OF-CTIL
- Acronym
- LCI
- Status last verified
- Jul 2015
- First submitted
- 17 Jun 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity
- ClinicalTrials.gov ID
- NCT02498223
- Acronym / sponsor ID
- LCI / SHEBA-15-2156-OF-CTIL
- Conditions
- Work Load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research arm | Experimental | Other: experiment protocol50 subjects (healthy soldiers, male and female) from combat units will undergo the experiment protocol. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- existence of any of undesired conditions detailed in the inclusion criteria.
- the physician decision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experiment protocolthe 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. | Other | research arm |
Primary outcome
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 )
3 secondary outcomes
Heart rate
Time frame: 3 experiment days
pressure at the shoulders and the waist
Time frame: 3 experiment days
walk analysis (composite)
Time frame: 3 experiment days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofir Frenkel, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experiment protocol in people with Work Load, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofir Frenkel, M.D (+972529243399, Ofir.Frenkel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen consumption (time frame: 3 experiment days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.