BFRT vs Standard PT After Total Knee Arthroplasty (BFRT-TKA)

Blood Flow Restriction Training Vs Standard Physical Therapy Following Total Knee Arthroplasty Prospective Intervention Study (Blood Flow Restriction Training: BFRT)

Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.

Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.

Primary Outcome Measures:

Quadriceps Strength: dynamometry (hand held)

Secondary Outcomes Measures:

Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test

Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks

Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: Blood Flow Restriction Training; Procedure: Standard Physical Therapy

Detailed Description

Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.

Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.

Primary Outcome Measures:

Quadriceps Strength: dynamometry (hand held)

Secondary Outcomes Measures:

Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test

Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks

Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm

Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Status post primary TKA and cleared by surgeon for Physical Therapy.
• Ages 50-79 years old
• Able to participate fully in PT
• Primary cruciate retaining or posterior stabilized TKA.

• Knee Range of Motion of surgical extremity is a minimum of 5° on full extension to 90° on full flexion

  • Exclusion Criteria:

• Unable to consent for study participation
• Unable to participate in preoperative testing
• Any ligamentous or osseous reconstruction at time of surgery that limits weight bearing
• History of Deep Vein Thrombosis
• Injury or recent procedure to uninvolved extremity within 6 months
• History of endothelial dysfunction
• History of Peripheral Vascular Disease including varicose veins
• Easy bruisability
• TKA is revision
• History of surgical wound complication on involved extremity
• History of stroke
• History of dementia
• History of neuromuscular disorder
• History of Chronic Obstructive Pulmonary Disease
• History of diabetes mellitus with neuropathy
• History of previous intra-articular fracture of involved extremity causing surgical fixation
• History of sickle cell trait/disease
• Previous participation in BFRT
• Any surgical procedure affecting their ability to complete all PT sessions or testing.
• History of functionally limiting arthritis in non-surgical Lower Extremity
• Prior contralateral Total Knee Arthroplasty
• Prior Total Hip Arthroplasty
• Positive pregnancy test
• Enrollment into another clinical research trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Flow Restriction Training; Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT involves placing the pressure cuff before the start of therapeutic exercises. Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching	Procedure: Blood Flow Restriction Training; Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises
Active Comparator: Standard Physical Therapy; Subjects will receive American College of Sports Medicine guided-strength training Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching	Procedure: Standard Physical Therapy; Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Strength	Quadriceps Strength measured using a handheld dynamoneter	12 weeks post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score, Jr,	Knee Injury and Osteoarthritis Outcome Score, Jr,	Pre-Op, 6 and 12 weeks and 12 months post-op
Veterans Rand -12	Veterans Rand -12	Pre-Op, 6 and 12 weeks and 12 months post-op
Four square Test	Subject will be asked to walk forward, sideways, backward and sideways over four squares.	Pre-Op, 6 and 12 weeks post-op
5x Sit to Stand Test	Subject will be asked to sit in a chair with back straight and feet on a flat surface positioned about shoulder width apart, arms crossed at chest and asked to stand up and sit down five times.	Pre-Op, 6 and 12 weeks and 12 months post-op
Quadriceps Strength	Quadriceps Strength measured using a handheld dynamoneter	6 weeks post-op
Quadriceps Strength	Quadriceps Strength measured using a handheld dynamoneter	12 months post-op

Collaborators and Investigators

• Sponsor: Norton Healthcare
• Investigators: Principal Investigator: Jeffrey Stimac, MD, Norton Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): December 29, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Blood Flow Restriction Training; Quadriceps Strengthening
• Other Study ID Numbers: 19-N0153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No