Effects OF Acute Aerobic Exercise On Higher Cerebral Functions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise
• Intervention / Treatment: Behavioral: Aerobic exercise; Other: None (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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy young adults

Exclusion Criteria:

• smokers
• cardiorespiratory disorders
• psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercising Group; 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.	Behavioral: Aerobic exercise; a moderate kind of physical activity with a heart rate between 65 & 70% maximum heart rate
Placebo Comparator: 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.	Other: None (control group); None (the control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Khyber Medical College, Peshawar

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 148/DME/KMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No