- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831036
The Impact of Physical Exercise on Navigation Performance in Soldier
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ramat- Gan
-
Tel-Hashomer, Ramat- Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: trial group
subjects in trial group will be following the experimental protocol (VO2max tests and spatial orientation tests) while performing a training program during the trial (3 months).
|
subjects in the trial group will follow a training program which includes 3 times a week running on a treadmill.
each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.
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.
|
Other: control group
following the experimental protocol (VO2max tests and spatial orientation tests)without performing additional exercise.
|
each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spatial learning (composite)
Time Frame: 20 experimental days for each participant
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximal aerobic capacity
Time Frame: 4 experimental days for each participant
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-16-3321-HS-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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