Effects OF Acute Aerobic Exercise On Higher Cerebral Functions

Exercise Clinical Trial

Official title:

Effects Of a Single Bout Of Acute Aerobic Exercise On Executive Brain Functions Of Young Adults: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861726
• Other study ID #: 148/DME/KMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Khyber Medical College, Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy young adults

Exclusion Criteria:

• smokers

• cardiorespiratory disorders

• psychiatric disorders

Related Conditions & MeSH terms

• Exercise

Intervention

Behavioral:
• Aerobic exercise
a moderate kind of physical activity with a heart rate between 65 & 70% maximum heart rate

Other:
• None (control group)
None (the control group)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical College, Peshawar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in the reaction time of stroop test 5 minutes before and 3 minutes after aerobic exercise will be recorded
Primary	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.	Change in the response time 5 minutes before and 3 minutes after aerobic exercise will be recorded
Primary	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.	Change in status of the response 5 minutes before and 3 minutes after aerobic exercise will be recorded
Primary	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.	Change in reaction time 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded
Primary	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.	Change in the number of false alarms 5 minutes before and 3 minutes after an acute session of aerobic exercise will be recorded