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

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06127667

Collaborator

(none)

102

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurotypical Cognitively Normal	Behavioral: aerobic exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental group

Healthy participants in 3 age groups

Behavioral: aerobic exercise

use of single bout of aerobic exercise

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55414

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Jacqueline Palmer, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT06127667

Other Study ID Numbers:

PT-2023-32375

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2023