Clinical trial NCT02644213: Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment
Official title: Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Examination
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-12-31
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: cognitive performance (composite)
timeFrame: 3 experimental days
measure: executive function
timeFrame: 3 experimental days
Secondary outcomes:
measure: lactic acid
timeFrame: 3 experimental days
measure: heart rate variability
timeFrame: 3 experimental days
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References: