Blood Flow Restriction Exercise Study

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT02868021

Run by

University of Florida

People needed

12

Starts

2016-12-12

Expected to finish

2018-08-01

Last updated by the study team

2019-07-24

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• United States, Florida UF Health — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.