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NCT Number: NCT06127667

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

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.

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Key information

Conditions

Neurotypical Cognitively Normal

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Jacqueline Palmer

CONTACT

[email protected]

240-446-1168

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

use of single bout of aerobic exercise

Primary outcomes

  1. cerebral blood flow velocity assessed using transcranial Doppler ultrasound

    Time frame: 1 week

    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.

  2. Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.

    Time frame: 1 week

    Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.

  3. Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG

    Time frame: 1 week

    Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Palmer

CONTACT

[email protected]

240-446-1168

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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