The Strong Brain Study

April 4, 2018 updated by: University of Florida

A Pilot Study to Evaluate the Role of Brain Integrity on Post-hospital Sarcopenia

To evaluate operational aspects of studying pre to post surgery/hospitalization changes in the integrity of a major white matter pathways and how these contribute to reductions in the ability to produce forceful muscle contractions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hospitalization is a strong and independent risk factor for Sarcopenia. Older adults who are hospitalized in the previous year experience greater losses of lean mass and muscle strength than their non-hospitalized peers. Most of the research has focused on understanding muscle atrophy as the cause of weakness. However, post-hospitalization muscle weakness is not solely due to muscle atrophy- it explains less than 10% of the variance. The investigators propose that the sequela of hospitalization (e.g. deconditioning, disease severity, etc.) reduces the integrity of brain motor pattern that is used to produce forceful muscle contractions. Evidence from the literature suggests that central nervous system impairments explain approximately 60% of the variance in the loss in muscle strength observed following hospitalization. However, while these findings have helped to move the field forward, the measures lack spatial resolution. Accordingly, there remains a major gap in understanding whether deterioration of specific brain motor tracts contribute to post-hospitalization induced sarcopenia. The investigators intend to conduct a prospective cohort study to examine the integrity of the cortical-spinal white matter tract in post-hospitalized older adults. However, the investigators lack some essential elements in which to conduct this future study. Therefore, this pilot study will refine the following: patient eligibility, feasibility of collecting outcomes in patients, variances for statistical power, influence of covariates, timeline, patient attrition rates, data analysis strategies and magnetic resonance imaging protocol for mapping the cortical-spinal tract. The investigators will accomplish these operational aims efficiently and cost-effectively by leveraging funding with a newly awarded R01 by Dr. Catherine Price, which seeks to identify pre-surgical neuroimaging biomarkers following total knee arthroplasty (TKA) (R01NR014181; IRB# 487-2012). Specifically, the investigators will add measures of sarcopenia (muscle strength, mass and gait) and assess the integrity of the cortico-spinal tract. Measures will be collected in 20 patients before and after hospitalization (prior to surgery, 3 months and 12 months post-surgery) and 20 controls who are matched in age and disease severity at similar time points. In summary, there are long-term impairments that result from hospitalization in older adults that are not explained by the illness alone. This pilot study will result in subsequent larger NIH funded studies because the research is distinct from all others being conducted on muscle function, aging and effects of hospitalization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Institute on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will comprise two age-matched participant groups: 1.) 'Healthy' non-demented (n=20) patients undergoing elective total knee arthroplasty, and 2.) age, education, and disease matched (osteoarthritis knee pain; n=20) non-surgery peers. We expect to screen 60 potential participants to yield 40 participants who complete the protocol. All participants will be recruited with the assistance of the Orthopedic Surgery Department at UFHealth. The parallel control group will originate from the parent study physician. Only right-handers will participate in this experiment because left-handedness is associated with greater variability in white matter organization and cognitive functions.

Description

Inclusion Criteria:

  • Aged 60 years old or older with no upper limit at time of baseline assessment
  • Right handed; restriction due to left-right hemisphere laterality and white matter pathways
  • Able to understand and speak English
  • Willing to give informed consent

Exclusion Criteria:

  • Any conditions that pose health risk with physical exertion during a strength test as discovered on a medical history (e.g. heart failure, surgical complications etc.)
  • Cancer requiring treatment in past 5 years (exception: non-melanoma skin cancer)
  • Serious infectious diseases (e.g., self-reported HIV, sepsis)
  • Myocardial infarction/ CVA within last six months
  • Congestive heart failure (NY stage III or IV)
  • Chronic hepatitis
  • History of organ transplantation
  • Seizure disorders
  • History of head trauma resulting in intensive care
  • Current diagnosis of alcoholism
  • Drug dependence, or a history of major tranquilizer use
  • History of major stroke(s)
  • Exposure to toxins or neuroleptics
  • History of encephalitis
  • Neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear palsy, or orthostatic hypertension that causes fainting
  • Major Depression or Major Depressive Episode within three months prior to study
  • Claustrophobia
  • Non-medical bodily metal
  • Pace-maker device
  • Less than five years of formal education
  • Inability to read or write
  • Self-reported hearing or vision impairment that interferes with standardized test administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-surgical group
Adults who have knee osteoarthritis, but do not elect to have a total knee replacement surgery.
Surgical group
Adults who have knee osteoarthritis and elect to have total knee replacement surgery.
Procedure: Total knee replacement surgery
The surgeon removes damaged cartilage and bone from the surface of the knee joint and replaces them with a man-made surface of metal and plastic.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: Change in baseline, 3 months and 12 months
We will measure plantar extension/flexion and knee extension/flexion strength using Isokinetic dynamometry (Biodex Inc., Shirley, NY). To prevent injury, participants will be secured to a padded chair using a lap and shoulder belts. To become accustomed to the testing machine, participants will first perform leg extensions with a light force applied to the target limb. Testing will commence after a short rest period that will be used to administer instruction and address any participant questions. Participants will perform 2 sets of each exercise for 15 repetitions at velocities of 60 degrees per second and 120 degrees per second. Tests will be done on both right and left sides and the maximal force will be determined. A 2-3 minute rest will be given between each set of exercise.
Change in baseline, 3 months and 12 months
Muscle mass
Time Frame: Change in baseline, 3 months and 12 months
Dual-energy X-ray absorptiometry (DEXA) whole body scan will be used to assess lean and fat mass of the lower extremity (Hologic, Discovery QDR Series, Bedford, MA). Participants will be asked to lie still on a table for approximately10 minutes while the scan is acquired by a certified technician.
Change in baseline, 3 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short physical performance batter score (SPPB)
Time Frame: Change in baseline, 3 months and 12 months
The SPPB test involves a brief performance battery based on timed short distance walk, repeated chair stands and balance test. Scores on each test is used to create a summary SPPB score that ranges from 0 (worst performers) to 12 (best performers).
Change in baseline, 3 months and 12 months
6-minute walk distance
Time Frame: Change in baseline, 3 months and 12 months
For the 6-minute walk test, participants will be asked to complete as much distance as possible on a circular walking course.
Change in baseline, 3 months and 12 months
Spatiotemporal gait characteristics
Time Frame: Change in baseline, 3 months and 12 months
step time, gait cycle, single support time, double support time, stance time, swing time, step length and stride length
Change in baseline, 3 months and 12 months
Brain MRI derived corticospinal tract integrity from foot motor cortex to cerebral peduncle
Time Frame: Change in baseline, 3 months and 12 months
This will be created by mapping two regions of interest: 1) Cerebral Peduncle and Foot/Left motor region. For the Cerebral Peduncle, we will use a method shown to be reliable (Triplett et al.). For the Foot/Left motor region, we will identify the foot cortex that will be guided by the areas of functional activation in the scanner and motor cortex regions of interest will be acquired from reliable raters.
Change in baseline, 3 months and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
perceived pain
Time Frame: Change in baseline, 3 months and 12 months
We will assess pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and The Coping Strategies Questionnaire-Revised (CSQ-R). Pain ratings will also be collected during strength testing. Participants will be instructed to rate pain sensations experienced immediately prior, at mid-point during, immediately following, and 5 minutes post completion of the strength testing. Pain intensity will be measured on a scale of 0 (no pain sensation) to 100 (the most intense pain sensation imaginable).
Change in baseline, 3 months and 12 months
physical activity
Time Frame: Change in baseline, 3 months and 12 months
Participants will be asked to wear an accelerometer (Actigraph Inc, Pensacola, FL) that monitors physical movements (e.g. pedometer) on the waist following each testing session. The monitor will be placed around the waist using an elastic strap. They will be asked to wear the monitors for up to 10 days. Total physical activity time will be measured.
Change in baseline, 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd M Manini, Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201300566-N
  • P30AG028740 (U.S. NIH Grant/Contract)
  • 566-2013 (Other Identifier: UF legacy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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