Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2016-12-12
2018-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
Strength testing
Test the strength of subject's lower extremity muscles on the dynamometer system
Short Physical Performance Battery (SPPB)
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Six-minute walk (SMW)
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Numerical pain scale
Measure pain using an 11-point numerical pain scale.
Self-assessed function
Using the Late Life Function and Disability Instrument.
Muscle biopsies
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
Strength testing
Test the strength of subject's lower extremity muscles on the dynamometer system
Short Physical Performance Battery (SPPB)
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Six-minute walk (SMW)
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Numerical pain scale
Measure pain using an 11-point numerical pain scale.
Self-assessed function
Using the Late Life Function and Disability Instrument.
Muscle biopsies
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Determination of 1 Repetition Maximum (1-RM)
Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM.
Blood flow restriction exercise
Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg.
Borg CR10 scale
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
Interventions
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Strength testing
Test the strength of subject's lower extremity muscles on the dynamometer system
Short Physical Performance Battery (SPPB)
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Six-minute walk (SMW)
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Numerical pain scale
Measure pain using an 11-point numerical pain scale.
Self-assessed function
Using the Late Life Function and Disability Instrument.
Muscle biopsies
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Determination of 1 Repetition Maximum (1-RM)
Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM.
Blood flow restriction exercise
Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg.
Borg CR10 scale
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
Eligibility Criteria
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Inclusion Criteria
* are scheduled for unilateral joint replacement surgery only
* are able to give consent and follow instructions
* are willing to complete up to 15 study visits
Exclusion Criteria
* patients over the age of 80 years old
* patients who live in a radius greater than 45 miles from the University of Florida (a feasible distance to allow for transportation to and from the clinical center for assessment visits)
* patients with impaired cognitive function and mental disease, (e.g. diagnosis of Alzheimer's disease)
* patients with paraplegia/extremity amputation
* patients with end stage renal disease requiring dialysis
* patients with uncontrolled diabetes and insulin-dependent diabetes
* patients with uncontrolled cardiovascular disease e.g. (Classes of Heart Failure (CHF) New York Heart Association (NYHA) class 3 or higher, BP \> 180/110 mmHg)
* patients with severe pulmonary disease requiring continuous oxygen therapy
* patients with active neoplasm
* patients with peripheral vascular disease or deep vein thrombosis (within the last 3 years)
* patients with structured exercise/Physical Therapy(PT)/Occupational Therapy (OT)/fitness program enrollment within 12 weeks prior to surgery and/or more than 2 hours per month on gym/fitness room exercises
* patients with BMI greater than 40 kg/m2
* patients with opioid use of more than 30 mg Morphine-equivalents per day
* patients with chronic oral steroid use
* patients with chronic anticoagulation (e.g. Plavix, Warfarin)
* patients with planned postoperative admission to a skilled nursing/inpatient rehab facility
* patients with ipsilateral joint disease involving hip, ankle or spine
* neurologic or other etiology of quadriceps wasting
* surgery within less than 4 weeks
* patients with comorbidities that the PI judges as not suitable for the study
* patients with a minimal mental status (MMSE) score below 24
55 Years
80 Years
ALL
No
Sponsors
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University of Florida Clinical and Translational Science Institute (CTSI)
UNKNOWN
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Rene Przkora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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United States, Florida UF Health
Gainesville, Florida, United States
Countries
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Other Identifiers
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IRB201601042
Identifier Type: -
Identifier Source: org_study_id
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