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

University of Minnesota (UMN)

Status: Enrolling

Conditions: Neurotypical; Cognitively Normal

Treatments: Behavioral: aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06127667

PT-2023-32375

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 21 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

102 participants in 1 patient group

Experimental group

Experimental group

Description:

Healthy participants in 3 age groups

Treatment:

Behavioral: aerobic exercise