Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 8:00 PM
Study NCT ID:
NCT04255758
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective interventional study model, all subjects undergo the same exercise intervention and results are compared to baseline values'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MREG cardiovascular pulse wavefront', 'timeFrame': '3 hours', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Cerebral perfusion fMRI', 'timeFrame': '3 hours', 'description': '5-minute MR imaging sequences evaluating changes in blood flow, scanned once before and multiple times after exercise intervention'}, {'measure': 'Heart rate (HR)', 'timeFrame': '3 hours', 'description': 'Wearable heart rate monitoring, measures heart beats per second, continuous throughout the study'}, {'measure': 'Blood pressure (BP)', 'timeFrame': '3 hours', 'description': 'Blood pressure monitoring, evaluates systolic and diastolic pressures (mmHg) continuous throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glymphatic system', 'cerebral perfusion', 'aerobic exercise'], 'conditions': ['Glymphatic System', 'Neurodegeneration']}, 'referencesModule': {'references': [{'pmid': '30892202', 'type': 'BACKGROUND', 'citation': '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': '29079431', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.\n\nTwenty 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-45\n* BMI 18-30\n* Resting Blood pressure \\< 140/90 mmHg\n\nExclusion Criteria:\n\n* History of a cardiac event\n* Insulin or medically treated diabetes\n* 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\n* Presence of ferromagnetic objects that would make MR imaging contraindicated\n* Claustrophobia\n* Abundant use of alcohol\n* Use of narcotics\n* Smoking of tobacco or consuming snuff tobacco\n* Diagnosed depressive or bipolar disorder\n* Abnormalities in resting ECG (revised by the study physician)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04255758', 'acronym': 'GLYMREG', 'briefTitle': 'Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Academic Investigational Study of Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults', 'orgStudyIdInfo': {'id': 'T6/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vigorous-intensity Aerobic Exercise', 'description': 'Vigorous-intensity aerobic exercise, single intervention', 'interventionNames': ['Other: Cycle Ergometer Exercise']}], 'interventions': [{'name': 'Cycle Ergometer Exercise', 'type': 'OTHER', 'description': '25 minutes, 70% VO2max steady state cycle ergometry exercise', 'armGroupLabels': ['Vigorous-intensity Aerobic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ilkka H Heinonen, PhD', 'role': 'CONTACT', 'email': 'ilkka.heinonen@utu.fi'}], 'facility': 'Turku PET Centre', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Ilkka Heinonen, PhD', 'role': 'CONTACT', 'email': 'ilkka.heinonen@utu.fi', 'phone': '+358 408 393 962'}], 'overallOfficials': [{'name': 'Ilkka Heinonen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku PET Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor, Department of Clinical Medicine', 'investigatorFullName': 'Ilkka Heinonen', 'investigatorAffiliation': 'Turku University Hospital'}}}}