OsteoarthritisNCT02320864
The Strong Brain Study
An observational study of Osteoarthritis and Sarcopenia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Sarcopenia
- What is being tested?
- Total knee replacement surgery
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Sarcopenia
- Being tested
- Total knee replacement surgery
- Keywords
- muscle strength, muscle weakness, hospitalization, surgery, total knee replacement
- Medical subject headings
- Osteoarthritis, Sarcopenia, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Total knee replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in baseline, 3 months and 12 months
Secondary outcomes (4)
Short physical performance batter score (SPPB)
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).
Measured: Change in baseline, 3 months and 12 months
6-minute walk distance
For the 6-minute walk test, participants will be asked to complete as much distance as possible on a circular walking course.
Measured: Change in baseline, 3 months and 12 months
Spatiotemporal gait characteristics
step time, gait cycle, single support time, double support time, stance time, swing time, step length and stride length
Measured: Change in baseline, 3 months and 12 months
Brain MRI derived corticospinal tract integrity from foot motor cortex to cerebral peduncle
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.
Measured: Change in baseline, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd M Manini, Ph.D., Principal investigator, University of FloridaAdam J Woods, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320864
- Sponsor's protocol ID
- IRB201300566-N
- Other IDs
- P30AG028740, 566-2013
- Status last verified
- Apr 2018
- First submitted
- 31 Jul 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Role of Brain Integrity on Post-hospital Sarcopenia
- ClinicalTrials.gov ID
- NCT02320864
- Acronym / sponsor ID
- IRB201300566-N
- Conditions
- Osteoarthritis, Sarcopenia
- Keywords
- muscle strength, muscle weakness, hospitalization, surgery, total knee replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical group | – | –Adults who have knee osteoarthritis, but do not elect to have a total knee replacement surgery. |
| Surgical group | – | Procedure: Total knee replacement surgeryAdults who have knee osteoarthritis and elect to have total knee replacement surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee replacement surgeryThe 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. | Procedure or surgery | Surgical group |
Primary outcome
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.
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.
4 secondary outcomes
Short physical performance batter score (SPPB)
Time frame: Change in baseline, 3 months and 12 months
6-minute walk distance
Time frame: Change in baseline, 3 months and 12 months
Spatiotemporal gait characteristics
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd M Manini, Ph.D. principal investigator
University of Florida
Adam J Woods, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Sarcopenia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: Change in baseline, 3 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.