An observational study in Central Nervous System and White Matter Disease, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Wake Forest University Health Sciences · Observational
Rapidly accumulating evidence indicates that the central nervous system (CNS) plays a pivotal role in mobility function with age-associated CNS changes strongly contributing to declining mobility. Studies linking the brain to mobility have used anatomical measures like brain volume and white matter integrity, and suggest that damage to the connecting fibers of the brain (white matter) is related to mobility impairment. Unfortunately, age-related structural white matter damage appears irreversible and only indirectly indicates the functional connectivity between brain regions. It is believed that functional brain network analyses have the potential to identify individuals that may benefit from interventions prior to the development of irreversible white matter lesions. The current project will assess both physical and cognitive function and integrate these variables with measures of brain network connectivity.
Studies linking the brain to mobility have used anatomical measures like brain volume and white matter integrity, and suggest that damage to the connecting fibers of the brain (white matter) is related to mobility impairment. Unfortunately, age-related structural white matter damage appears irreversible and only indirectly indicates the functional connectivity between brain regions. The preliminary data show that directly assessed patterns of functional connectivity correlate with mobility function and can be changed by interventions that improve mobility function. It is not known how changes in CNS functional connectivity relate to changes in mobility, information critical for the design of interventions targeting CNS connectivity to improve mobility impairments. It is clear that structural connectivity underlies functional connectivity, and that structural brain lesions result in altered functional connections. B-NET will assess white matter (WM) disease burden and microstructural changes and relate these changes to functional brain network connectivity. We hypothesize that because sensory motor cortex community structure (SMC-CS) characterizes current brain organization, it will be associated with mobility function independently of anatomical damage markers. Such knowledge may permit earlier identification of persons at high risk for mobility decline and facilitate earlier and better targeted interventions.
Community-dwelling adults reflecting the gender/race composition of Forsyth County in the target age-range will be identified. The 70 and up age-span was chosen because epidemiologic data shows accelerating functional decline and increased prevalence of white matter abnormalities across this age-range.
Exclusion Criteria:
The group will consist of 240 community-dwelling older adults with a range of mobility function based on the short physical performance battery (SPPB).
Change in Extended Short Physical Performance Battery (eSPPB)
The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.
Time frame: baseline and 6, 18, and 30 months
Change in Cardiovascular fitness
The fast-paced 400M walk protocol will be used.
Time frame: baseline and 18 and 30 months
Change in Digit Symbol Substitution Test (DSST)
The WAIS-III Digit Symbol Substitution Test will be used.
Time frame: baseline and 18 and 30 months
Change in Gait Speed
This will be assessed over 4 meters 3 times at usual pace and 3 times at fast pace using an instrumented mat (GAITRite System), which provides data on average step and stride length, initial and terminal double support time, as well as the variability in these measures
Time frame: baseline and 18 and 30 months
Change in lower extremity muscle strength
Maximal isokinetic knee extension and flexion strength will be measured using an isokinetic dynamometer
Time frame: baseline and 18 and 30 months
Change in postural sway
Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform.
Time frame: baseline and 18 and 30 months
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences