Cognitive ChangeNCT05905081
Acute Effects of Moderate Intensity Aerobic Exercise on Cognitive Functions in Young Adult Males
A study testing aerobic exercise in people with Cognitive Change, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 1 Sep 2023
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No known psychiatric, cognitive or physical health problems
- No limiting issue for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
- Physical activity level according to International Physical Activity Questionnaire (IPAQ) < 3000 MET
Who cannot join
- Discomfort/illness that will interfere with physical activity
- Using any medication or stimulants
- Having limitations for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Physical Fitness and Aerobic Exercise on Cognitive Functions in Young Adult Males
60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before and after the intervention.
- Conditions
- Cognitive Change
- Being tested
- aerobic exercise
- Keywords
- acute aerobic exercise, cognition, university students, physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
30-minutes aerobic exercise intervention on the bicycle ergometer. The exercise protocol includes 5 minutes of warm-up, 20 minutes of loading and 5 minutes of cool-down. The intensity of the exercise will be adjusted to be between 46% and 63% of the VO2max calculated according to the exercise programming guide published by the American College of Sports Medicine (ACSM), and the perceived effort level on the Borg scale will be 12-13. Warm-up and cool-down periods will be set to 46% of VO2max and Borg perceived exertion level below 9.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | 30-minutes moderate-intensity aerobic exercise will be performed according to ACSM guidelines Receives: Other: aerobic exercise |
| Control Group | No intervention | 30-minutes video screening while sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor inhibition
Go/NoGo Task
Measured: Baseline and 30 mins after baseline
Change in working memory capacity
N-Back Task
Measured: Baseline and 30 mins after baseline
Secondary outcomes (2)
Change in psychomotor rate
Simple reaction time task
Measured: Baseline and 30 mins after baseline
Change in visual inspection and attention
Spatial cueing
Measured: Baseline and 30 mins after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group comparison, before and after intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şermin Tükel Akay, Izmir University of Economics
- Investigators
- Şermin Tükel Akay, PhD, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905081
- Sponsor's protocol ID
- 4930-GOA
- Status last verified
- Sep 2023
- First submitted
- 3 May 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Physical Fitness and Aerobic Exercise on Cognitive Functions in Young Adult Males
- ClinicalTrials.gov ID
- NCT05905081
- Acronym / sponsor ID
- 4930-GOA
- Conditions
- Cognitive Change
- Keywords
- acute aerobic exercise, cognition, university students, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- 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.
60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before and after the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group comparison, before and after intervention
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: aerobic exercise30-minutes moderate-intensity aerobic exercise will be performed according to ACSM guidelines |
| Control Group | No intervention | –30-minutes video screening while sitting |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No known psychiatric, cognitive or physical health problems
- No limiting issue for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
- Physical activity level according to International Physical Activity Questionnaire (IPAQ) < 3000 MET
Key exclusion criteria (3 listed)
- Discomfort/illness that will interfere with physical activity
- Using any medication or stimulants
- Having limitations for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
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 |
|---|---|---|
| aerobic exercise30-minutes aerobic exercise intervention on the bicycle ergometer. The exercise protocol includes 5 minutes of warm-up, 20 minutes of loading and 5 minutes of cool-down. The intensity of the exercise will be adjusted to be between 46% and 63% of the VO2max calculated according to the exercise programming guide published by the American College of Sports Medicine (ACSM), and the perceived effort level on the Borg scale will be 12-13. Warm-up and cool-down periods will be set to 46% of VO2max and Borg perceived exertion level below 9. | Other | Exercise Group |
Primary outcome
Change in motor inhibition
Time frame: Baseline and 30 mins after baseline
Go/NoGo Task
Change in working memory capacity
Time frame: Baseline and 30 mins after baseline
N-Back Task
2 secondary outcomes
Change in psychomotor rate
Time frame: Baseline and 30 mins after baseline
Change in visual inspection and attention
Time frame: Baseline and 30 mins after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- 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.
Şermin Tükel Akay, PhD principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Cognitive Change, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor inhibition (time frame: Baseline and 30 mins after baseline). 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 13 Sep 2023.