Effects OF Acute Aerobic Exercise On Higher Cerebral Functions

Sponsor
Khyber Medical College, Peshawar (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05861726
Collaborator
(none)
38
2
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic exercise
  • Other: None (control group)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effects Of a Single Bout Of Acute Aerobic Exercise On Executive Brain Functions Of Young Adults: A Randomized Control Trial
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Change in performance of Stroop Test before & after an acute session of aerobic exercise [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.

  2. Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise. [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.

  3. Change in performance of "Stop Signal Task Test" before & after an acute session of aerobic exercise. [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.

  4. Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise. [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.

  5. Change in performance of "N-Back task/2-Back task " before & after an acute session of aerobic exercise. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy young adults
Exclusion Criteria:
  • smokers

  • cardiorespiratory disorders

  • psychiatric disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Khyber Medical College, Peshawar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khyber Medical College, Peshawar
ClinicalTrials.gov Identifier:
NCT05861726
Other Study ID Numbers:
  • 148/DME/KMC
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 17, 2023