NCT02831036

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 10, 2016

Last Update Submit

July 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • maximal aerobic capacity

    4 experimental days for each participant

Study Arms (2)

trial group

EXPERIMENTAL

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).

Other: training programOther: VO2max testOther: spatial orientation test

control group

OTHER

following the experimental protocol (VO2max tests and spatial orientation tests)without performing additional exercise.

Other: VO2max testOther: spatial orientation test

Interventions

subjects in the trial group will follow a training program which includes 3 times a week running on a treadmill.

trial group

each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.

control grouptrial group

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.

control grouptrial group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • civilian healthy man, aged 18-30
  • without any neurological or psychiatric disorder
  • not wearing eyeglasses

You may not qualify if:

  • athletes or trained man (for both groups)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

MeSH Terms

Conditions

Spatial Learning

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • Haggai Schermann, M.D

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2016

First Posted

July 13, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

April 1, 2018

Last Updated

July 13, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations