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

Cognitively Normal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127667
• Other study ID #: PT-2023-32375
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Jacqueline Palmer
• Phone: 240-446-1168
• Email: palmerj[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitively Normal

Intervention

Behavioral:
• aerobic exercise
use of single bout of aerobic exercise

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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