Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06127667

Conditions

Neurotypical

Cognitively Normal

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

aerobic exercise

Study Details

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

Study ID

NCT06127667

Start date

Oct 15, 2024

Status verified date

Mar, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

102 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental group

Healthy participants in 3 age groups

Interventions

aerobic exercise

use of single bout of aerobic exercise

Primary outcome measure

  • cerebral blood flow velocity assessed using transcranial Doppler ultrasound [ Time Frame: 1 week ]
  • Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically. [ Time Frame: 1 week ]
  • Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Jacqueline Palmer

240-446-1168brainsinmotion@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Jacqueline Palmer

240-446-1168brainsinmotion@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-03-27.