Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-27 @ 5:16 AM
Study NCT ID:
NCT06127667
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral blood flow velocity assessed using transcranial Doppler ultrasound', 'timeFrame': '1 week', 'description': 'Includes recordings from transcranial Doppler ultrasound of cerebral blood flow (CBF) velocity performed at the first session during rest, sit-to-stand, transfer, and single bout of aerobic exercise.'}, {'measure': 'Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.', 'timeFrame': '1 week', 'description': 'Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.'}, {'measure': 'Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG', 'timeFrame': '1 week', 'description': 'Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurotypical', 'Cognitively Normal']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults\n* the absence of major orthopedic disability\n* cognitively normal (MoCA score ≥ 26/30 in older adult group)\n* vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers\n* English speaking\n* ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.\n\nExclusion Criteria:\n\n* insulin-dependent diabetes\n* peripheral neuropathy\n* myocardial infarction or symptoms of coronary artery disease within 2 years\n* congestive heart failure or class IV heart failure\n* any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.'}, 'identificationModule': {'nctId': 'NCT06127667', 'briefTitle': 'Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan', 'orgStudyIdInfo': {'id': 'PT-2023-32375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Healthy participants in 3 age groups', 'interventionNames': ['Behavioral: aerobic exercise']}], 'interventions': [{'name': 'aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'use of single bout of aerobic exercise', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Palmer', 'role': 'CONTACT', 'email': 'palmerj@umn.edu', 'phone': '240-446-1168'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Jacqueline Palmer', 'role': 'CONTACT', 'email': 'palmerj@umn.edu', 'phone': '240-446-1168'}], 'overallOfficials': [{'name': 'Jacqueline Palmer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}