Development of Clinical Methods to Evaluate Neural Function in Aging

NCT02073201 | Completed DMC

• 2 other identifiers: IRB201300835-N2P30AG028740
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A primary focus of the University of Florida (UF) Claude D. Pepper Older Americans Independence Center (OAIC) is to build a comprehensive understanding of the causes and consequences of declining physical function and disability development among older adults. To date investigators have largely focused on sarcopenia, the age-related decline in skeletal muscle mass and strength, as the primary contributor to physical decline. However, recent findings indicate that changes in the central and/or peripheral nervous systems may play a larger role than previously thought in the development of functional limitations. These fields hold extensive promise for identifying novel contributors to age-related functional decline. Therefore, the overarching aim of this project is to develop the ability of RC1 to assess novel neural contributors to mobility and overall physical function. Importantly, the development of these techniques will provide the RC1 with the tools to evaluate the potential involvement of the central and peripheral nervous systems in age-related functional decline and disablement. The primary aim of this project is to develop techniques for quantifying peripheral motor unit number and size as well as spinal cord integrity.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Neuromuscular integrity by motor unit function

  Tasks that require prolonged muscle force are carried out by slow, fatigue-resistant motor units, while tasks that require a quick but short increase in muscle force are mostly performed by fast motor units. Many of the postural muscles have a large proportion of S motor units. On the other hand, muscles that participate in quick limb movements such as kicking, hitting, or catching typically have a large proportion of FR and FF motor units. Most muscles, however, have a relatively wide range of the various motor units, reflecting their participation in a variety of motor tasks.

  Baseline

Secondary Outcomes (1)

• Structural integrity of the brain and spinal cord

  Baseline

Study Arms (3)

High-functioning older adults

Participants with a SPPB score ≥ 11 will be categorized as high-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

Other: High-functioning older adults

Lower-functioning older adults

Participants with a SPPB score ≤ 8 will be categorized as lower-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

Other: Lower-functioning older adults

Young adults

Participants between the 20 - 30 years of age. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

Other: Young adults

Interventions

High-functioning older adults OTHER

Participants with a SPPB score ≥ 11 will be categorized as high-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

High-functioning older adults

Lower-functioning older adults OTHER

Participants with a SPPB score ≤ 8 will be categorized as lower-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

Lower-functioning older adults

Young adults OTHER

Participants between the 20 - 30 years of age. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).

Young adults

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We propose to recruit 30 persons over 60 years of age who are classified as either high- or low functioning based on performance on the Short Physical Performance Battery (SPPB). Participants with a SPPB score ≥ 11 will be categorized as high-functioning, while the low-functioning group will include participants with a SPPB score ≤ 8. We will also recruit 15 persons between 20-30 years of age. We will target cognitively intact (3MSE \> 80) older adults who are free of overt neuromuscular impairments (no dementias, brain tumors, major depression, history of stroke, etc.).

You may qualify if:

• Age 60 years and older OR 20-30 years
• Higher functioning older adults: Score ≥ 11 on the Short Physical Performance Battery (SPPB)
• Lower functioning older adults: Score ≤ 8 on the SPPB
• Body mass index: 20-35 kg/m2 to ensure homogeneity and strength of signal for EMG and MRI analyses
• Willingness to participate in all study procedures

You may not qualify if:

• Failure to provide informed consent;
• Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
• active treatment for cancer or history of cancer in the past year
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
• previous stroke with upper and/or lower extremities involvement within the last 6 months
• history of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
• renal disease requiring dialysis
• lung disease requiring steroids
• lower extremity amputation
• severe osteoarthritis or rheumatoid arthritis that interferes with physical function
• complicated diabetes requiring insulin
• A known diagnosis of dementia
• Unable to communicate because of severe hearing loss or speech disorder;
• Severe visual impairment, which would preclude completion of the assessments and/or intervention;
• Simultaneous participation in another intervention trial

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UF Clinical Translational Research Building

Gainesville, Florida, 32611, United States

Location

Study Officials

• Thomas Buford, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 2, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)