Executive FunctionNCT01718405
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
A study testing Cognitive function after exercise test and Blood sample analysis in people with Executive Function, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function
- What is being tested?
- Cognitive function after exercise test and Blood sample analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Nov 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical Education Students
- Able to sign consent form
Who cannot join
- Competitive athletes
- Smokers
- Neurologic or psychologic orders
- Chronic diseases
- Head Injuries
- Hospitalization in the previous 3 months
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.
- Conditions
- Executive Function
- Being tested
- Cognitive function after exercise test, Blood sample analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive function after exercise testOther
The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.
Blood sample analysisGenetic
In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Each individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session. Receives: Other: Cognitive function after exercise test; Genetic: Blood sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functioning After Exercise
Computerized battery of tests evaluating cognitive functioning
Measured: Five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718405
- Sponsor's protocol ID
- 0049
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
- ClinicalTrials.gov ID
- NCT01718405
- Acronym / sponsor ID
- 0049
- Conditions
- Executive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 31 Oct 2012 (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.
Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Cognitive function after exercise test, Genetic: Blood sample analysisEach individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physical Education Students
- Able to sign consent form
Key exclusion criteria (7 listed)
- Competitive athletes
- Smokers
- Neurologic or psychologic orders
- Chronic diseases
- Head Injuries
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 |
|---|---|---|
| Cognitive function after exercise testThe individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests. | Other | Exercise Group |
| Blood sample analysisIn the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism. | Genetic | Exercise Group |
Primary outcome
Cognitive Functioning After Exercise
Time frame: Five minutes
Computerized battery of tests evaluating cognitive functioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive function after exercise test and Blood sample analysis in people with Executive Function, run by Hillel Yaffe 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 2 inclusion and 7 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 Oct 2012. 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 Sharon Tsuk, PhD (972-522-640642, sharontsuk1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Functioning After Exercise (time frame: Five minutes). 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 Oct 2012.