Clinical trial NCT02868021: Blood Flow Restriction Exercise Study
Official title: Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Elderly
Exercise
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Florida Clinical and Translational Science Institute (CTSI)
First posted: 2016-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes between the two group assessed by muscle strength
timeFrame: Changes from baseline (pre-op) up to 2 weeks post-op
Secondary outcomes:
measure: Changes between the two group assessed by Short Physical Performance Battery (SPPB)
timeFrame: Changes from baseline (pre-op) up to 2 weeks post-op
measure: Changes between the two group assessed by Six-minute walk (SMW) test
timeFrame: Changes from baseline (pre-op) up to 2 weeks post-op
measure: Changes between the two group assessed by pain
timeFrame: Changes from baseline (pre-op) up to 2 weeks post-op
measure: Changes between the two group assessed by self-assessment outcomes
timeFrame: Changes from baseline (pre-op) up to 2 weeks post-op
measure: Changes between the two group assessed by biological targets on the muscle tissue
timeFrame: Up to 4 hours (end of surgery)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: United States, Florida UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Rene Przkora, MD
role: PRINCIPAL_INVESTIGATOR
References: