NCT04734808

Brief Summary

The aim of this study is to investigate brain activity with EEG during incremental cycling at various cycling intensities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

January 22, 2021

Last Update Submit

April 20, 2021

Conditions

Keywords

EEGBrain ImagingBrain WavesCyclingIntensity

Outcome Measures

Primary Outcomes (1)

  • Beta band suppression

    Reduction of beta is one of the cortical markers which is usually obtained from the central electrodes and occurs with movement initiation.

    During the intervention

Secondary Outcomes (1)

  • Brain mapping

    During the intervention

Interventions

ElectroencephalographyDIAGNOSTIC_TEST

Electroencephalography is an electrophysiological monitoring method to record electrical activity of the brain.

Also known as: EEG
ElectromyographyDIAGNOSTIC_TEST

Electromyography is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. We will use the hdEMG version.

Also known as: hdEMG

Eligibility Criteria

Age22 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Heathy and recreationaly active men
  • No significant muscular, skeleton or nervous system damage
  • Cycloergometry test (positive)

You may not qualify if:

  • Nervous system disorders
  • Cardiovascular disorders (e.g.: high blood pressure, arrhythmia...)
  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maribor

Maribor, Slovenia

RECRUITING

Related Publications (4)

  • Bailey SP, Hall EE, Folger SE, Miller PC. Changes in EEG during graded exercise on a recumbent cycle ergometer. J Sports Sci Med. 2008 Dec 1;7(4):505-11. eCollection 2008.

    PMID: 24149958BACKGROUND
  • Fontes EB, Bortolotti H, Grandjean da Costa K, Machado de Campos B, Castanho GK, Hohl R, Noakes T, Min LL. Modulation of cortical and subcortical brain areas at low and high exercise intensities. Br J Sports Med. 2020 Jan;54(2):110-115. doi: 10.1136/bjsports-2018-100295. Epub 2019 Aug 16.

    PMID: 31420319BACKGROUND
  • Fontes EB, Okano AH, De Guio F, Schabort EJ, Min LL, Basset FA, Stein DJ, Noakes TD. Brain activity and perceived exertion during cycling exercise: an fMRI study. Br J Sports Med. 2015 Apr;49(8):556-60. doi: 10.1136/bjsports-2012-091924. Epub 2013 Jun 1.

    PMID: 23729175BACKGROUND
  • Enders H, Cortese F, Maurer C, Baltich J, Protzner AB, Nigg BM. Changes in cortical activity measured with EEG during a high-intensity cycling exercise. J Neurophysiol. 2016 Jan 1;115(1):379-88. doi: 10.1152/jn.00497.2015. Epub 2015 Nov 4.

    PMID: 26538604BACKGROUND

MeSH Terms

Interventions

ElectroencephalographyElectromyography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMyography

Central Study Contacts

Teja Ličen, MsC

CONTACT

Uros Marusic, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Uroš Marušič

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 2, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 15, 2021

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations