Spatial LearningNCT02831036
The Impact of Physical Exercise on Navigation Performance in Soldier
A study testing training program, VO2max test and spatial orientation test in people with Spatial Learning, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spatial Learning
- What is being tested?
- training program, VO2max test and spatial orientation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- civilian healthy man, aged 18-30
- without any neurological or psychiatric disorder
- not wearing eyeglasses
Who cannot join
- athletes or trained man (for both groups)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spatial Learning
- Being tested
- training program, VO2max test, spatial orientation test
- Medical subject headings
- Spatial Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training programOther
subjects in the trial group will follow a training program which includes 3 times a week running on a treadmill.
VO2max testOther
each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.
spatial orientation testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: training program; Other: VO2max test; Other: spatial orientation test |
| control group | Other | following the experimental protocol (VO2max tests and spatial orientation tests)without performing additional exercise. Receives: Other: VO2max test; Other: spatial orientation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 experimental days for each participant
Secondary outcomes (1)
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.
Measured: 4 experimental days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial LearningStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Sponsor
- Investigators
- Haggai Schermann, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831036
- Sponsor's protocol ID
- SHEBA-16-3321-HS-CTIL
- Status last verified
- Jul 2016
- First submitted
- 10 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Exercise on Navigation Performance in Soldier
- ClinicalTrials.gov ID
- NCT02831036
- Acronym / sponsor ID
- SHEBA-16-3321-HS-CTIL
- Conditions
- Spatial Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Other: training program, Other: VO2max test, Other: spatial orientation testsubjects 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). |
| control group | Other | Other: VO2max test, Other: spatial orientation testfollowing the experimental protocol (VO2max tests and spatial orientation tests)without performing additional exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- civilian healthy man, aged 18-30
- without any neurological or psychiatric disorder
- not wearing eyeglasses
Key exclusion criteria (1 listed)
- athletes or trained man (for both groups)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training programsubjects in the trial group will follow a training program which includes 3 times a week running on a treadmill. | Other | trial group |
| VO2max testeach subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness. | Other | control group, trial group |
| spatial orientation testeach 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, trial group |
Primary outcome
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.
1 secondary outcome
maximal aerobic capacity
Time frame: 4 experimental days for each participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haggai Schermann, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training program, VO2max test and spatial orientation test in people with Spatial Learning, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haggai Schermann, M.D (+972828771014, Haggai.Schermann@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spatial learning (composite) (time frame: 20 experimental days for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.