Physical ExaminationNCT02644213
Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment
A study testing protocol of using CAREN and MOTEK systems in people with Physical Examination, run by Sheba Medical Center at 1 site in Israel.
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. 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
- Physical Examination
- What is being tested?
- protocol of using CAREN and MOTEK systems
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2017
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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:
- CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome.
- 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).
- Conditions
- Physical Examination
- Being tested
- protocol of using CAREN and MOTEK systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocol of using CAREN and MOTEK systemsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| research arm | Experimental | 12 young, healthy civilian volunteers will participate in this study. The experiment will take place in a dome room.
The experiment will be performed according to the protocol of using CAREN and MOTEK systems:
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.
each subject will undergo the same experiment protocol. Receives: Other: protocol of using CAREN and MOTEK systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 experimental days
executive function
executive function will be evaluated based on the validated Trail Making Test (TMT).
Measured: 3 experimental days
Secondary outcomes (2)
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.
Measured: 3 experimental days
heart rate variability
HRV will be measured during rest and effort using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Measured: 3 experimental days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExaminationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofir Frenkel, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644213
- Sponsor's protocol ID
- SHEBA-15-2664-OF-CTIL
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT02644213
- Acronym / sponsor ID
- SHEBA-15-2664-OF-CTIL
- Conditions
- Physical Examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 31 Dec 2015 (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.
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.
Detailed 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:
- CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome.
- 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).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research arm | Experimental | Other: protocol of using CAREN and MOTEK systems12 young, healthy civilian volunteers will participate in this study. The experiment will take place in a dome room. The experiment will be performed according to the protocol of using CAREN and MOTEK systems: 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. each subject will undergo the same experiment protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| protocol of using CAREN and MOTEK systemsThe 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. | Other | research arm |
Primary outcome
cognitive performance (composite)
Time frame: 3 experimental days
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.
executive function
Time frame: 3 experimental days
executive function will be evaluated based on the validated Trail Making Test (TMT).
2 secondary outcomes
lactic acid
Time frame: 3 experimental days
heart rate variability
Time frame: 3 experimental days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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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.
Ofir Frenkel, 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 protocol of using CAREN and MOTEK systems in people with Physical Examination, 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 5 inclusion and 6 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 31 Dec 2015. 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 Ofir Frenkel, M.D (+972529243399, Ofir.Frenkel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive performance (composite) (time frame: 3 experimental days). The study lists 2 primary outcomes in all. 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 31 Dec 2015.