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

Not Applicable

Recruiting

• Conditions: Neurotypical; Cognitively Normal
• Interventions: Behavioral: aerobic exercise

• Registration Number: NCT06127667
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2024-10
• Study Start: 2024-10-15
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	aerobic exercise	Healthy participants in 3 age groups

Primary Outcome Measures

Name	Time	Method
Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.	1 week	Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.
Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG	1 week	Recordings from 64-channels of EEG electrodes, kinetic, and kinematic biomechanical data during standing balance reactions will be collected.
cerebral blood flow velocity assessed using transcranial Doppler ultrasound	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States