NCT04255758

Brief Summary

This study investigates changes in glymphatic flow in the brain acutely after vigorous-intensity steady-state aerobic exercise. Twenty subjects (10 male and 10 female) perform 25 minute submaximal cycle ergometry exercise and the changes in the glymphatic flow and cerebral perfusion are evaluated using a variety of MRI sequences (e.g. MREG).

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 below P25 for not_applicable

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

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2020

Last Update Submit

February 8, 2021

Conditions

Keywords

glymphatic systemcerebral perfusionaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • MREG cardiovascular pulse wavefront

    Is processed into three-dimensional vector fields and used as an assessment of glymphatic flow, scanned once before and multiple times after exercise intervention in 5-minute sequences

    3 hours

Secondary Outcomes (3)

  • Cerebral perfusion fMRI

    3 hours

  • Heart rate (HR)

    3 hours

  • Blood pressure (BP)

    3 hours

Study Arms (1)

Vigorous-intensity Aerobic Exercise

EXPERIMENTAL

Vigorous-intensity aerobic exercise, single intervention

Other: Cycle Ergometer Exercise

Interventions

25 minutes, 70% VO2max steady state cycle ergometry exercise

Vigorous-intensity Aerobic Exercise

Eligibility Criteria

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

You may qualify if:

  • Age 18-45
  • BMI 18-30
  • Resting Blood pressure \< 140/90 mmHg

You may not qualify if:

  • History of a cardiac event
  • Insulin or medically treated diabetes
  • Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
  • Presence of ferromagnetic objects that would make MR imaging contraindicated
  • Claustrophobia
  • Abundant use of alcohol
  • Use of narcotics
  • Smoking of tobacco or consuming snuff tobacco
  • Diagnosed depressive or bipolar disorder
  • Abnormalities in resting ECG (revised by the study physician)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

RECRUITING

Related Publications (2)

  • Rajna Z, Raitamaa L, Tuovinen T, Heikkila J, Kiviniemi V, Seppanen T. 3D Multi-Resolution Optical Flow Analysis of Cardiovascular Pulse Propagation in Human Brain. IEEE Trans Med Imaging. 2019 Sep;38(9):2028-2036. doi: 10.1109/TMI.2019.2904762. Epub 2019 Mar 15.

    PMID: 30892202BACKGROUND
  • von Holstein-Rathlou S, Petersen NC, Nedergaard M. Voluntary running enhances glymphatic influx in awake behaving, young mice. Neurosci Lett. 2018 Jan 1;662:253-258. doi: 10.1016/j.neulet.2017.10.035. Epub 2017 Oct 25.

    PMID: 29079431BACKGROUND

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ilkka Heinonen, PhD

    Turku PET Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilkka Heinonen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Prospective interventional study model, all subjects undergo the same exercise intervention and results are compared to baseline values
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor, Department of Clinical Medicine

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

February 8, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations