Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment

NCT02644213 | Unknown

• 1 other identifier: SHEBA-15-2664-OF-CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the research is to evaluate the influence of physical and cognitive load as pre-mission activity on the soldier's physical and cognitive performance, in compare to physical load alone. In order to do so, 12 healthy subjects will perform stimulated road march using a virtual reality environment combined with cognitive load and without, and their physical and cognitive performance will be evaluated by tests before and after.

Conditions

Physical Examination

Outcome Measures

Primary Outcomes (2)

• cognitive performance (composite)

  grade will be calculated according to the subject's performance in the computerized tests (SYNWIN activity research services) at the virtual reality environment . performance evaluation is based on the parameters: concentration, memory, visual perception, data processing capability, response time and multitasking.

  3 experimental days

• executive function

  executive function will be evaluated based on the validated Trail Making Test (TMT).

  3 experimental days

Secondary Outcomes (2)

• lactic acid

  3 experimental days

• heart rate variability

  3 experimental days

Study Arms (1)

research arm

EXPERIMENTAL

12 young, healthy civilian volunteers will participate in this study. The experiment will take place in a dome room. The experiment will be performed according to the protocol of using CAREN and MOTEK systems: 1. CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome. 2. MOTEK (Motek Medical©, the Netherlands) which is a two track treadmill (for each leg) placed on a rotatable platform. each subject will undergo the same experiment protocol.

Other: protocol of using CAREN and MOTEK systems

Interventions

protocol of using CAREN and MOTEK systems OTHER

The subjects will perform randomly 3 experimental days (at least weak between one to another): * simulated road march using a virtual reality environment without additional load * simulated road march using a virtual reality environment which combines cognitive load during the road march. Cognitive tasks for example: navigation, identification and remembering cars/aircraft. * without physical or cognitive load (without march, waiting between performance evaluations) as control.

research arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-30
• healthy civilians volunteers
• with no background illnesses
• with history of combat unit service in the IDF.
• fit to perform 10 Km moderate march while carrying load.

You may not qualify if:

• The existence or suspicion of existing cardiac or respiratory disease.
• Hypertension.
• Diabetes.
• Any muscles or skeleton condition.
• Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
• Infectious disease 3 days prior to the experiment.

Sponsors & Collaborators

• Sheba Medical Center: lead

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

Ofir Frenkel, M.D

CONTACT

+972529243399; Ofir.Frenkel@sheba.health.gov.il

Study Design

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

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

IL (1)