NCT05861726

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 17, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

March 14, 2023

Last Update Submit

May 14, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

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.

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.

Other: None (control group)

Interventions

a moderate kind of physical activity with a heart rate between 65 \& 70% maximum heart rate

Exercising Group

None (the control group)

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults

You may not qualify if:

  • smokers
  • cardiorespiratory disorders
  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseControl Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

May 17, 2023

Study Start

June 1, 2023

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

May 17, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share