NCT05905081

Brief Summary

60 healthy male university students will be included in this study. Physical fitness parameters, fluid intelligence, and physical activity level will be measured at baseline. Participants will be randomised to one of two testing schedules, groups will complete either a 30-minutes aerobic exercise session or a resting control condition. Cognitive measures (simple reaction time task, go/nogo task, spatial cueing, n-back task) will be tested before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

May 3, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

acute aerobic exercisecognitionuniversity studentsphysical fitness

Outcome Measures

Primary Outcomes (2)

  • Change in motor inhibition

    Go/NoGo Task

    Baseline and 30 mins after baseline

  • Change in working memory capacity

    N-Back Task

    Baseline and 30 mins after baseline

Secondary Outcomes (2)

  • Change in psychomotor rate

    Baseline and 30 mins after baseline

  • Change in visual inspection and attention

    Baseline and 30 mins after baseline

Other Outcomes (7)

  • International Physical Activity Questionnaire (IPAQ)

    At baseline

  • VO2max

    At baseline

  • Raven's Progressive Matrices

    At baseline

  • +4 more other outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

30-minutes moderate-intensity aerobic exercise will be performed according to ACSM guidelines

Other: aerobic exercise

Control Group

NO INTERVENTION

30-minutes video screening while sitting

Interventions

30-minutes aerobic exercise intervention on the bicycle ergometer. The exercise protocol includes 5 minutes of warm-up, 20 minutes of loading and 5 minutes of cool-down. The intensity of the exercise will be adjusted to be between 46% and 63% of the VO2max calculated according to the exercise programming guide published by the American College of Sports Medicine (ACSM), and the perceived effort level on the Borg scale will be 12-13. Warm-up and cool-down periods will be set to 46% of VO2max and Borg perceived exertion level below 9.

Exercise Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No known psychiatric, cognitive or physical health problems
  • No limiting issue for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)
  • Physical activity level according to International Physical Activity Questionnaire (IPAQ) \< 3000 MET

You may not qualify if:

  • Discomfort/illness that will interfere with physical activity
  • Using any medication or stimulants
  • Having limitations for performing exercise according to Physical Activity Readiness Questionnaire (PAR-Q+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Şermin Tükel Akay, PhD

    Izmir University of Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two group comparison, before and after intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

May 3, 2023

First Posted

June 15, 2023

Study Start

June 20, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations