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

NCT06127667 | Recruiting

• 1 other identifier: PT-2023-32375
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurotypical; Cognitively Normal

Outcome Measures

Primary Outcomes (3)

• cerebral blood flow velocity assessed using transcranial Doppler ultrasound

  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.

  1 week

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

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

  1 week

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

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

  1 week

Study Arms (1)

Experimental group

EXPERIMENTAL

Healthy participants in 3 age groups

Behavioral: aerobic exercise

Interventions

aerobic exercise BEHAVIORAL

use of single bout of aerobic exercise

Experimental group

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jacqueline Palmer

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Palmer

CONTACT

240-446-1168; brainsinmotion@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 13, 2023
• Study Start: October 15, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)