Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: aerobic exercise.
- Who it may be relevant to
- Registry conditions: Neurotypical, Cognitively Normal. Basic parameters: 21 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral aerobic exercise
use of single bout of aerobic exercise
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06127667 · PT-2023-32375