Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Changes between the two group assessed by muscle strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Six-minute walk (SMW) (Behavioral)
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.
Intervention: Numerical pain scale (Behavioral)
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.
Intervention: Self-assessed function (Behavioral)
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.
Intervention: Muscle biopsies (Procedure)
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.
Intervention: Strength testing (Device)
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.
Intervention: Short Physical Performance Battery (SPPB) (Behavioral)
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.
Intervention: Strength testing (Device)
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.
Intervention: Short Physical Performance Battery (SPPB) (Behavioral)
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.
Intervention: Six-minute walk (SMW) (Behavioral)
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.
Intervention: Numerical pain scale (Behavioral)
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.
Intervention: Self-assessed function (Behavioral)
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.
Intervention: Muscle biopsies (Procedure)
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.
Intervention: Determination of 1 Repetition Maximum (1-RM) (Device)
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.
Intervention: Blood flow restriction exercise (Device)
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.
Intervention: Borg CR10 scale (Behavioral)
Outcomes
Primary Outcomes
Changes between the two group assessed by muscle strength
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
Test the strength of subject's lower extremity muscles on the dynamometer system
Secondary Outcomes
- Changes between the two group assessed by Short Physical Performance Battery (SPPB)(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by self-assessment outcomes(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by pain(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by biological targets on the muscle tissue(Up to 4 hours (end of surgery))
- Changes between the two group assessed by Six-minute walk (SMW) test(Changes from baseline (pre-op) up to 2 weeks post-op)