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.

Study Overview

• Status: Recruiting
• Conditions: Cognitively Normal; Neurotypical
• Intervention / Treatment: Behavioral: aerobic exercise

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Palmer; Phone Number: 240-446-1168; Email: brainsinmotion@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Jacqueline Palmer; Phone Number: 240-446-1168; Email: brainsinmotion@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Healthy participants in 3 age groups	Behavioral: aerobic exercise; use of single bout of aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jacqueline Palmer, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: PT-2023-32375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No