Blood Flow Restriction Exercise Study



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:55 - 80
Updated:11/10/2018
Start Date:December 12, 2016
End Date:August 1, 2018

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Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery

This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up
to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure
clinical outcomes such as strength, lower extremity function, and pain.

The purpose of this study is to test the feasibility and efficacy of a low-resistance
exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative
period of patients awaiting TKA. BFR exercise is a new exercise method that has not been
studied in the perioperative period. The investigators will compare our intervention to a
no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is
feasible in the preoperative period and if BFR exercise will improve functional,
physiological, and molecular outcomes when compared to patients without exercise.

Inclusion Criteria:

- are scheduled for elective TKA for osteoarthritis

- 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 below the age of 55 years old

- 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
We found this trial at
1
site
13706 Innovation Drive
Gainesville, Florida 32610
Phone: 352-494-3165
?
mi
from
Gainesville, FL
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