Glymphatic SystemGLYMREGNCT04255758
Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults
A study testing Cycle Ergometer Exercise in people with Glymphatic System and Neurodegeneration, run by Turku University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glymphatic System, Neurodegeneration
- What is being tested?
- Cycle Ergometer Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 8 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45
- BMI 18-30
- Resting Blood pressure < 140/90 mmHg
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku PET Centre
Turku, 20521
Ilkka H Heinonen, PhD, ilkka.heinonen@utu.fi
About this study
Official title: Academic Investigational Study of Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults
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).
Read the detailed description
The glymphatic system is a drainage system for the brain to help maintain fluid balance and extract waste metabolites. Glymphatic system function (healthy glymphatic flow) may prevent accumulation of harmful substances and therefore slow down the onset of neurodegenerative diseases.
The hypothesis is, that glymphatic flow could be increased through exercise and enhanced cerebral arterial pulsality, which might explain some of the brain health benefits of exercise proven in epidemiological studies. This study indirectly investigates the acute changes in the glymphatic flow acutely after aerobic exercise using MREG that measures pulse wave propagation as an indirect surrogate marker for glymphatic flow.
Twenty healthy subjects (n=20, 10 male, 10 female, age 18-45 years) will perform 25 minute 70%VO2max cycle ergometry exercise. The glymphatic flow and cerebral perfusion will be measured using magnetic resonance imaging sequences before and after exercise. The glymphatic flow is measured using 10 Hz fMRI technique called magnetic resonance encephalography (MREG). In addition, perfusion MRI is used to evaluate changes in brain perfusion.
- Conditions
- Glymphatic System, Neurodegeneration
- Being tested
- Cycle Ergometer Exercise
- Keywords
- glymphatic system, cerebral perfusion, aerobic exercise
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle Ergometer ExerciseOther
25 minutes, 70% VO2max steady state cycle ergometry exercise
| Study group | Role | What they receive |
|---|---|---|
| Vigorous-intensity Aerobic Exercise | Experimental | Vigorous-intensity aerobic exercise, single intervention Receives: Other: Cycle Ergometer Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (3)
Cerebral perfusion fMRI
5-minute MR imaging sequences evaluating changes in blood flow, scanned once before and multiple times after exercise intervention
Measured: 3 hours
Heart rate (HR)
Wearable heart rate monitoring, measures heart beats per second, continuous throughout the study
Measured: 3 hours
Blood pressure (BP)
Blood pressure monitoring, evaluates systolic and diastolic pressures (mmHg) continuous throughout the study
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glymphatic SystemStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional study model, all subjects undergo the same exercise intervention and results are compared to baseline values
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkka Heinonen, Turku University Hospital
- Investigators
- Ilkka Heinonen, PhD, Principal investigator, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255758
- Sponsor's protocol ID
- T6/2020
- Acronym
- GLYMREG
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30892202von 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.
PubMed 29079431
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic Investigational Study of Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults
- ClinicalTrials.gov ID
- NCT04255758
- Acronym / sponsor ID
- GLYMREG / T6/2020
- Conditions
- Glymphatic System, Neurodegeneration
- Keywords
- glymphatic system, cerebral perfusion, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The glymphatic system is a drainage system for the brain to help maintain fluid balance and extract waste metabolites. Glymphatic system function (healthy glymphatic flow) may prevent accumulation of harmful substances and therefore slow down the onset of neurodegenerative diseases.
The hypothesis is, that glymphatic flow could be increased through exercise and enhanced cerebral arterial pulsality, which might explain some of the brain health benefits of exercise proven in epidemiological studies. This study indirectly investigates the acute changes in the glymphatic flow acutely after aerobic exercise using MREG that measures pulse wave propagation as an indirect surrogate marker for glymphatic flow.
Twenty healthy subjects (n=20, 10 male, 10 female, age 18-45 years) will perform 25 minute 70%VO2max cycle ergometry exercise. The glymphatic flow and cerebral perfusion will be measured using magnetic resonance imaging sequences before and after exercise. The glymphatic flow is measured using 10 Hz fMRI technique called magnetic resonance encephalography (MREG). In addition, perfusion MRI is used to evaluate changes in brain perfusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective interventional study model, all subjects undergo the same exercise intervention and results are compared to baseline values
| Arm | Type | Receives |
|---|---|---|
| Vigorous-intensity Aerobic Exercise | Experimental | Other: Cycle Ergometer ExerciseVigorous-intensity aerobic exercise, single intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45
- BMI 18-30
- Resting Blood pressure < 140/90 mmHg
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycle Ergometer Exercise25 minutes, 70% VO2max steady state cycle ergometry exercise | Other | Vigorous-intensity Aerobic Exercise |
Primary outcome
MREG cardiovascular pulse wavefront
Time frame: 3 hours
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 secondary outcomes
Cerebral perfusion fMRI
Time frame: 3 hours
Heart rate (HR)
Time frame: 3 hours
Blood pressure (BP)
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 30892202Rajna 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.
- Background: PubMed 29079431von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Heinonen, PhD principal investigator
Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle Ergometer Exercise in people with Glymphatic System and Neurodegeneration, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilkka Heinonen, PhD (+358 408 393 962, ilkka.heinonen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MREG cardiovascular pulse wavefront (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.