ExerciseNCT05861726
Effects OF Acute Aerobic Exercise On Higher Cerebral Functions
A study testing Aerobic exercise in people with Exercise, run by Khyber Medical College, Peshawar.
Trial summary
We are comparing higher cerebral functions including cognitive flexibility, inhibitory control and working memory in healthy young adults between a group of acute aerobic exercise and a control group. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
Who cannot join
- smokers
- cardiorespiratory disorders
- psychiatric disorders
About this study
Official title: Effects Of a Single Bout Of Acute Aerobic Exercise On Executive Brain Functions Of Young Adults: A Randomized Control Trial
We are comparing higher cerebral functions including cognitive flexibility, inhibitory control and working memory in healthy young adults between a group of acute aerobic exercise and a control group.
Read the detailed description
The objective of this study is to compare cognitive flexibility, inhibitory control, and working memory in healthy young adults between two groups: a group undergoing acute aerobic exercise and a control group.
Methodology:
Study Design: A Randomized Controlled Trial Study Setting: The Physiology Laboratory at Khyber Medical College, Peshawar Study Duration: The study will last for three months. Sample Size: The study will include 19 participants in each group - the Exercising group (E-Group) and the Control group (C-Group).
Healthy young people between 18-25 years who are non-smokers will be included. Sampling: The enrollment in the Randomised Control Trial will be conveniently based, wherein all those who meet the inclusion and exclusion criteria will be enrolled as per study numbers. A lottery method will be adopted for randomization.
Procedure:
The first step is to take ethical approval from the Institutional Research \& Ethical Review Board. Following which, after taking informed consent from the participants, the enrolled participants will be randomly allocated to 2 groups. A demographic questionnaire will be filled. This will be followed by a general physical examination.
Both groups will be familiarized with the executive function tasks, while the E-group will have an additional session regarding the exercise protocol.
Both groups will have an initial assessment of executive functions using online psytoolkit followed by intervention. The E-group will undergo 30 minutes of treadmill walking at 60-65% of HRmax with continuous recording of heart rate and ECG via the Biopac system, while the control group session will consist of sitting idly and quietly in the laboratory doing nothing with continuous recording of heart rate and ECG via the Biopac student lab system.
In the end, executive function tests will be assessed before and after exercise using online psytoolkit.org. The data will be extracted via a properly designed proforma and on Microsoft Excel sheet.
Statistical Analysis:
Statistical Package for Social Sciences (SPSS)25.0 will be used for statistical analysis.
- Conditions
- Exercise
- Being tested
- Aerobic exercise, None (control group)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
a moderate kind of physical activity with a heart rate between 65 \& 70% maximum heart rate
None (control group)Other
None (the control group)
| Study group | Role | What they receive |
|---|---|---|
| Exercising Group | Active comparator | The exercising group shall have pre-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit followed by intervention.
The intervention for the group being acute aerobic exercise, which will comprise of 30 minutes of treadmill walking at 60-65% of Heart Rate max with continuous recording of heart rate and ECG via Biopac MP36 Student Lab system.
This will be followed by post-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit. Receives: Behavioral: Aerobic exercise |
| Control Group | Placebo comparator | The control group will also have pre-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit.
The control group will undergo NO EXERCISE intervention. They will sit idly in laboratory for 30 minutes with continuous recording of heart rate and ECG via Biopac system.
The executive brain functions of the control group will be re-assessed vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit. Receives: Other: None (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance of Stroop Test before & after an acute session of aerobic exercise
Stroop test will be used to assess cognitive flexibility aspect of "executive brain functions".
The reaction time in milliseconds to identify the congruent and incongruent words in the stroop test will be measured.
Measured: Change in the reaction time of stroop test 5 minutes before and 3 minutes after aerobic exercise will be recorded
Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise.
"Stop signal task" test will be used to assess the inhibitory control aspect of "executive brain functions".
The response time in milliseconds will be measured in the test.
Measured: Change in the response time 5 minutes before and 3 minutes after aerobic exercise will be recorded
Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise.
"Stop signal task" test will be used to assess the inhibitory control aspect of "executive brain functions".
Status of the response(1=correct, 2=wrong, 3=timeout) will be measured in the test.
Measured: Change in status of the response 5 minutes before and 3 minutes after aerobic exercise will be recorded
Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise.
"N-Back task/2-Back task" test will be used to assess the working memory aspect of "executive brain functions".
The reaction time taken in milliseconds to correctly match target letters in the test will be measured.
Measured: Change in reaction time 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded
Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise.
"N-Back task/2-Back task" test will be used to assess the working memory aspect of "executive brain functions".
The number of false alarms on the test will be measured.
Measured: Change in the number of false alarms 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical College, Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861726
- Sponsor's protocol ID
- 148/DME/KMC
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of a Single Bout Of Acute Aerobic Exercise On Executive Brain Functions Of Young Adults: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05861726
- Acronym / sponsor ID
- 148/DME/KMC
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Khyber Medical College, PeshawarUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 17 May 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.
We are comparing higher cerebral functions including cognitive flexibility, inhibitory control and working memory in healthy young adults between a group of acute aerobic exercise and a control group.
Detailed description
The objective of this study is to compare cognitive flexibility, inhibitory control, and working memory in healthy young adults between two groups: a group undergoing acute aerobic exercise and a control group.
Methodology:
Study Design: A Randomized Controlled Trial Study Setting: The Physiology Laboratory at Khyber Medical College, Peshawar Study Duration: The study will last for three months. Sample Size: The study will include 19 participants in each group - the Exercising group (E-Group) and the Control group (C-Group).
Healthy young people between 18-25 years who are non-smokers will be included. Sampling: The enrollment in the Randomised Control Trial will be conveniently based, wherein all those who meet the inclusion and exclusion criteria will be enrolled as per study numbers. A lottery method will be adopted for randomization.
Procedure:
The first step is to take ethical approval from the Institutional Research \& Ethical Review Board. Following which, after taking informed consent from the participants, the enrolled participants will be randomly allocated to 2 groups. A demographic questionnaire will be filled. This will be followed by a general physical examination.
Both groups will be familiarized with the executive function tasks, while the E-group will have an additional session regarding the exercise protocol.
Both groups will have an initial assessment of executive functions using online psytoolkit followed by intervention. The E-group will undergo 30 minutes of treadmill walking at 60-65% of HRmax with continuous recording of heart rate and ECG via the Biopac system, while the control group session will consist of sitting idly and quietly in the laboratory doing nothing with continuous recording of heart rate and ECG via the Biopac student lab system.
In the end, executive function tests will be assessed before and after exercise using online psytoolkit.org. The data will be extracted via a properly designed proforma and on Microsoft Excel sheet.
Statistical Analysis:
Statistical Package for Social Sciences (SPSS)25.0 will be used for statistical analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercising Group | Active comparator | Behavioral: Aerobic exerciseThe exercising group shall have pre-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit followed by intervention. The intervention for the group being acute aerobic exercise, which will comprise of 30 minutes of treadmill walking at 60-65% of Heart Rate max with continuous recording of heart rate and ECG via Biopac MP36 Student Lab system. This will be followed by post-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit. |
| Control Group | Placebo comparator | Other: None (control group)The control group will also have pre-intervention assessment of executive brain functions vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit. The control group will undergo NO EXERCISE intervention. They will sit idly in laboratory for 30 minutes with continuous recording of heart rate and ECG via Biopac system. The executive brain functions of the control group will be re-assessed vide Stroop test, Trail making test \& N-Back task/2-Back by using online psytoolkit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adults
Key exclusion criteria (3 listed)
- smokers
- cardiorespiratory disorders
- psychiatric disorders
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 exercisea moderate kind of physical activity with a heart rate between 65 \& 70% maximum heart rate | Behavioural | Exercising Group |
| None (control group)None (the control group) | Other | Control Group |
Primary outcome
Change in performance of Stroop Test before & after an acute session of aerobic exercise
Time frame: Change in the reaction time of stroop test 5 minutes before and 3 minutes after aerobic exercise will be recorded
Stroop test will be used to assess cognitive flexibility aspect of "executive brain functions". The reaction time in milliseconds to identify the congruent and incongruent words in the stroop test will be measured.
Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise.
Time frame: Change in the response time 5 minutes before and 3 minutes after aerobic exercise will be recorded
"Stop signal task" test will be used to assess the inhibitory control aspect of "executive brain functions". The response time in milliseconds will be measured in the test.
Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise.
Time frame: Change in status of the response 5 minutes before and 3 minutes after aerobic exercise will be recorded
"Stop signal task" test will be used to assess the inhibitory control aspect of "executive brain functions". Status of the response(1=correct, 2=wrong, 3=timeout) will be measured in the test.
Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise.
Time frame: Change in reaction time 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded
"N-Back task/2-Back task" test will be used to assess the working memory aspect of "executive brain functions". The reaction time taken in milliseconds to correctly match target letters in the test will be measured.
Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise.
Time frame: Change in the number of false alarms 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded
"N-Back task/2-Back task" test will be used to assess the working memory aspect of "executive brain functions". The number of false alarms on the test will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Exercise, run by Khyber Medical College, Peshawar.
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 1 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: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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 performance of Stroop Test before & after an acute session of aerobic exercise (time frame: Change in the reaction time of stroop test 5 minutes before and 3 minutes after aerobic exercise will be recorded). The study lists 5 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 17 May 2023.