The Impact of Physical Exercise on Navigation Performance in Soldier

Spatial Learning Clinical Trial

Official title:

The Impact of Physical Exercise on Navigation Performance in Soldier

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02831036
• Other study ID #: SHEBA-16-3321-HS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 10, 2016
• Last updated: July 10, 2016
• Start date: October 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2016
• Source: Sheba Medical Center
• Contact: Haggai Schermann, M.D
• Phone: +972828771014
• Email: Haggai.Schermann[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

20 healthy man, 10 in trial group and 10 in control group (randomly divided) will participate in the experiment on order to evaluate if improvement in physical fitness influences spatial learning in humans.

Description:

subjects in both groups will perform 4 sets of VO2max test and spatial orientation test with a month between them (total 3 month).

in addition, subjects in trial group will follow a training program throughout the trial (running on treadmill 3 times a week), suited according to their result in the first VO2max test.

in each set VO2max test will be perform before spatial orientation test , in order to evaluated the subject`s aerobic fitness. the spatial orientation test is composed of 5 following days in which the subject has 3 attempts to arrive to a destination in xbox one controller using a virtual glasses (Oculus Rift DK2). each attempt duration is 2 min.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• civilian healthy man, aged 18-30

• without any neurological or psychiatric disorder

• not wearing eyeglasses

Exclusion Criteria:

• athletes or trained man (for both groups)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Spatial Learning

Intervention

Other:
• training program
subjects in the trial group will follow a training program which includes 3 times a week running on a treadmill.
• VO2max test
each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.
• spatial orientation test
each subject will undergo 4 spatial orientation tests during the trial (month between 2 tests), each test is composed of 5 following days in which the subject will wear virtual reality glasses (Oculus Rift DK2) and attempt to arrive different destinations in a virtual maze tasks (using xbox one controller). each day will be given 3 attempts, the duration of each attempt is 2 min.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spatial learning (composite)	each spatial orientation test length is 5 days. spatial learning is evaluated through time for completion and number of errors out of 3 attempts each day.	20 experimental days for each participant	No
Secondary	maximal aerobic capacity	VO2max tests along the trial are performed in order to evaluate the improvement or lack of improvement in both groups in correlation with their spatial learning.	4 experimental days for each participant	No