The Strong Brain Study

NCT02320864 | Completed DMC

• 3 other identifiers: IRB201300566-NP30AG028740566-2013
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Sarcopenia

Keywords

muscle strength; muscle weakness; hospitalization; surgery; total knee replacement

Outcome Measures

Primary Outcomes (2)

• muscle strength

  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

  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 Outcomes (4)

• Short physical performance batter score (SPPB)

  Change in baseline, 3 months and 12 months

• 6-minute walk distance

  Change in baseline, 3 months and 12 months

• Spatiotemporal gait characteristics

  Change in baseline, 3 months and 12 months

• Brain MRI derived corticospinal tract integrity from foot motor cortex to cerebral peduncle

  Change in baseline, 3 months and 12 months

Other Outcomes (2)

• perceived pain

  Change in baseline, 3 months and 12 months

• physical activity

  Change in baseline, 3 months and 12 months

Study Arms (2)

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

Interventions

Total knee replacement surgery PROCEDURE

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.

Surgical group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institute on Aging

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Sarcopenia; Muscle Weakness

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Pathologic Processes

Study Officials

• Todd M Manini, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Adam J Woods, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: December 19, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)