Brain Networks and Mobility Function: B-NET

NCT03430427 | Completed

• 2 other identifiers: IRB000464601R01AG052419-01A1
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Nervous System; White Matter Disease

Keywords

BNET; Brain Networks; Mobility Function; SMCCS

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 6, 18, and 30 months

Secondary Outcomes (2)

• Change in Cardiovascular fitness

  baseline and 18 and 30 months

• Change in Digit Symbol Substitution Test (DSST)

  baseline and 18 and 30 months

Other Outcomes (3)

• Change in Gait Speed

  baseline and 18 and 30 months

• Change in lower extremity muscle strength

  baseline and 18 and 30 months

• Change in postural sway

  baseline and 18 and 30 months

Study Arms (1)

Community-Dwelling Older Adults

The group will consist of 240 community-dwelling older adults with a range of mobility function based on the short physical performance battery (SPPB).

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Community-dwelling adults aged ≥70 years
• Willing to provide informed consent; ability to communicate with study personnel.

You may not qualify if:

• Serious or uncontrolled chronic disease such as:
• Cancer (stage 3 or 4) or having had radiation or chemotherapy in the past year
• Uncontrolled angina
• Heart failure (stage 3-4)
• Respiratory disease requiring the use of oxygen
• Uncontrolled endocrine/metabolic disease (fasting glucose \>250mg/dL)
• Liver failure (AST \> 40IU/L and/or ALT \> 44 IU/L)
• Renal failure requiring dialysis
• Clinically diagnosed neurologic diseases: Parkinson's disease; Amyotrophic Lateral Sclerosis (ALS); Multiple Sclerosis, prior stroke with residual effects lasting longer than 24hrs
• Diagnosis of schizophrenia, bipolar, or other psychotic disorder
• Diagnosis of Alzheimer's disease or evidence of impaired cognitive function
• Prior traumatic brain injury with residual deficits
• Unwilling or unable to have an MRI brain scan (see MRI screening form).
• Dependent on a walker or another person to ambulate.
• Plans to relocate in the next 2- 3 years.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Links

• Effects of a Motor Imagery Task on Functional Brain Network Community Structure in Older Adults: Data from the Brain Networks and Mobility Function (B-NET) Study
• Corrigendum: Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study
• Examining the intersection of cognitive and physical function measures: Results from the brain networks and mobility (B-NET) study
• Associations of physical function and body mass index with functional brain networks in community-dwelling older adults

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and DNA will be retained for later analysis and for future research

MeSH Terms

Conditions

Leukoencephalopathies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stephen Kritchevsky, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 12, 2018
• Study Start: July 20, 2018
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)