Blood Flow Restriction Exercise Study

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Strength testing; Behavioral: Short Physical Performance Battery (SPPB); Behavioral: Six-minute walk (SMW); Behavioral: Numerical pain scale; Behavioral: Self-assessed function; Procedure: Muscle biopsies; Device: Determination of 1 Repetition Maximum (1-RM); Device: Blood flow restriction exercise; Behavioral: Borg CR10 scale

• Registration Number: NCT02868021
• Lead Sponsor: University of Florida

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 Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Study Start: 2016-12-12
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EX-BFR group	Determination of 1 Repetition Maximum (1-RM)	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.
NO-EX group	Six-minute walk (SMW)	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.
EX-BFR group	Numerical pain scale	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.
NO-EX group	Strength testing	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.
NO-EX group	Self-assessed function	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.
NO-EX group	Muscle biopsies	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.
EX-BFR group	Strength testing	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.
EX-BFR group	Short Physical Performance Battery (SPPB)	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.
EX-BFR group	Six-minute walk (SMW)	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.
EX-BFR group	Muscle biopsies	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.
NO-EX group	Short Physical Performance Battery (SPPB)	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.
NO-EX group	Numerical pain scale	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.
EX-BFR group	Self-assessed function	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.
EX-BFR group	Blood flow restriction exercise	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.
EX-BFR group	Borg CR10 scale	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.

Primary Outcome Measures

Name	Time	Method
Changes between the two group assessed by muscle strength	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 Outcome Measures

Name	Time	Method
Changes between the two group assessed by Short Physical Performance Battery (SPPB)	Changes from baseline (pre-op) up to 2 weeks post-op	SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Changes between the two group assessed by self-assessment outcomes	Changes from baseline (pre-op) up to 2 weeks post-op	Assessed using the Late Life Function and Disability Instrument
Changes between the two group assessed by pain	Changes from baseline (pre-op) up to 2 weeks post-op	Measure pain using an 11-point numerical pain scale
Changes between the two group assessed by biological targets on the muscle tissue	Up to 4 hours (end of surgery)	Analysis of the muscle tissue will focus on metabolism, inflammation, autophagy, apoptosis and other mechanisms of muscular atrophy.
Changes between the two group assessed by Six-minute walk (SMW) test	Changes from baseline (pre-op) up to 2 weeks post-op	SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.

Trial Locations

Locations (1)

United States, Florida UF Health; 🇺🇸 Gainesville, Florida, United States