NCT05689606

Brief Summary

It is widely known that exercise creates structural and functional changes in the brain. Synaptic plasticity develops through exercise, thus improving brain functions. It is suggested that skeletal muscle contraction and peripheral signal molecules secreted from various tissues, especially skeletal muscle, contribute to exercise's effect on the brain's structure and function. These signals synthesized and released from skeletal muscle are called myokines. Brain-derived neurotrophic factor (BDNF) and Cathepsin B are two of these myokines, which have been reported to cross the blood-brain barrier following secretion in the periphery and affect the structure and functions of the brain. Transcranial magnetic stimulation (TMS) allows to evaluate the synaptic plasticity responses of the motor cortex to exercise, while cognitive function responses are evaluated via cognitive tests. Additionally, exercise type and intensity influence the responses of cortical excitability and cognitive function. This research proposal aims to investigate how acute high-intensity intermittent exercise (HIIT) changes primary motor cortex (M1) excitability, M1-related cognitive functions, and peripheral BDNF and Cathepsin B levels in healthy sedentary adults and to investigate the relationship between these neurophysiological parameters. All parameters will be measured before and after the acute exercise. M1 excitability will be evaluated through resting motor threshold, short interval intracortical inhibition, and input-output curve measurements. Cognitive functions will be evaluated through mental rotation and working memory tasks, and peripheral signal responses will be measured by serum levels of BDNF and Cathepsin B. Our hypotheses are: 1) Acute HIIT will increase peripheral BDNF and CTSB level, cortical excitability, and M1-specific cognitive function performance. 2) M1 excitability, cognitive function performance, and peripheral BDNF and CTSB increase will be related following exercise. Our findings will have the potential to be a guide for the integration of exercise into daily life and will provide cortical and peripheral data on the neurophysiological basis of the relationship between exercise and cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

October 10, 2022

Last Update Submit

August 1, 2024

Conditions

Keywords

HIITTMSBDNFCathepsin Bcognitive performance

Outcome Measures

Primary Outcomes (7)

  • Resting motor threshold

    The amount of transcranial magnetic stimulation machine output necessary to produce a motor-evoked potential that exceeds a defined peak-to-peak amplitude. Lower scores mean a better outcome.

    Change from Baseline resting motor threshold immediately following acute exercise

  • Short interval intracortical inhibition

    The relative amplitude reduction of motor evoked potentials by subthreshold conditioning stimuli.

    Change from Baseline short interval intracortical inhibition immediately following acute exercise

  • Input output curve

    The input-output curve is a sigmoid-shaped relation between the MEP amplitude at incremented TMS intensities. Higher scores mean a better outcome.

    Change from Baseline input output curve immediately following acute exercise

  • Working memory

    The small amount of information that can be held in mind and used in the execution of cognitive tasks. Higher scores mean a better outcome.

    Change from Baseline working memory score immediately following acute exercise

  • Serum BDNF

    Serum level of BDNF. Higher scores mean a better outcome.

    Change from Baseline serum BDNF immediately following acute exercise

  • Mental rotation

    The ability to transform a mental representation of an object so as to accurately predict how the object would look from a different angle. Higher scores mean a better outcome.

    Change from Baseline mental rotation score immediately following acute exercise

  • Serum Cathepsin B

    Serum level of Cathepsin B. Higher scores mean a better outcome.

    Change from Baseline serum Cathepsin B immediately following acute exercise

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group performs acute high-intensity interval training.

Behavioral: Exercise

Control group

NO INTERVENTION

The Control group includes the same participants. In this session, they do not exercise, and they watch a nature documentary.

Interventions

ExerciseBEHAVIORAL

Exercise includes acute high-intensity interval training.

Exercise group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being right-handed
  • Aged between 20 and 30 years
  • Being sedentary

You may not qualify if:

  • having intracranial implants
  • history of psychiatric or neurological disease, seizure, any serious medical condition or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

January 19, 2023

Study Start

October 7, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

August 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations