Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan

NCT ID: NCT06127667

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2028-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neurotypical Cognitively Normal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental group

Healthy participants in 3 age groups

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type BEHAVIORAL

use of single bout of aerobic exercise

Interventions

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aerobic exercise

use of single bout of aerobic exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
* the absence of major orthopedic disability
* cognitively normal (MoCA score ≥ 26/30 in older adult group)
* vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
* English speaking
* ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.

Exclusion Criteria

* insulin-dependent diabetes
* peripheral neuropathy
* myocardial infarction or symptoms of coronary artery disease within 2 years
* congestive heart failure or class IV heart failure
* any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.
Minimum Eligible Age

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline Palmer

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacqueline Palmer

Role: CONTACT

240-446-1168

Facility Contacts

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Jacqueline Palmer

Role: primary

240-446-1168

Other Identifiers

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PT-2023-32375

Identifier Type: -

Identifier Source: org_study_id

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