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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02644213
Collaborator
(none)
12
1
1
12
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: protocol of using CAREN and MOTEK systems
N/A

Detailed Description

12 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test.

Afterwards, the subjects will perform randomly 3 experimental days, each consist of physical and cognitive performance evaluation before and after simulated road march using a virtual reality environment; once without additional load, once combining cognitive load during the road march, and once without physical load (without march, waiting between evaluations) as control.

The experiment will take place in a dome room, and the systems being used are:
  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.

cognitive tasks for example: navigation, identification and remembering cars/aircraft.

Physical and cognitive performance will be evaluated at each experimental day, before and after performing the protocol. at the end of the march, cognitive performance will be evaluated by validated tests on laptop (SYNWIN activity research services) and executive function evaluation based on Trail Making Test (TMT), afterwards, Physical performance will be evaluated by HRV and time to exhaustion test (30 min after the end of cognitive tests).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: research arm

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: CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome. 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
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.

Outcome Measures

Primary Outcome Measures

  1. cognitive performance (composite) [3 experimental days]

    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.

  2. executive function [3 experimental days]

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

Secondary Outcome Measures

  1. lactic acid [3 experimental days]

    lactic acid is a marker for anaerobic effort evaluating, lactic acid level is assessed from blood drop (finger sting) using lactate scout analyzer. lactic acid will be measured before and after time to exhaustion test.

  2. heart rate variability [3 experimental days]

    HRV will be measured during rest and effort using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheba medical center Tel-Hashomer Ramat- Gan Israel

Sponsors and Collaborators

  • Sheba Medical Center

Investigators

  • Principal Investigator: Ofir Frenkel, M.D, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02644213
Other Study ID Numbers:
  • SHEBA-15-2664-OF-CTIL
First Posted:
Dec 31, 2015
Last Update Posted:
Dec 31, 2015
Last Verified:
Dec 1, 2015

Study Results

No Results Posted as of Dec 31, 2015