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

Physical Examination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02644213
• Other study ID #: SHEBA-15-2664-OF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2015
• Last updated: December 29, 2015
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Physical Examination

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	executive function	executive function will be evaluated based on the validated Trail Making Test (TMT).	3 experimental days	No
Secondary	lactic acid	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.	3 experimental days	No
Secondary	heart rate variability	HRV will be measured during rest and effort using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	3 experimental days	No