BFRT vs Standard PT After Total Knee Arthroplasty

NCT ID: NCT04366336

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2021-12-29

Brief Summary

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.

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Blood Flow Restriction Training

Intervention Type: PROCEDURE

Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises

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

Group Type: ACTIVE_COMPARATOR

Standard Physical Therapy

Intervention Type: PROCEDURE

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

Interventions

Blood Flow Restriction Training

Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norton Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Stimac, MD

Role: PRINCIPAL_INVESTIGATOR

Norton Healthcare

Locations

Norton Healthcare

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

19-N0153

Identifier Type: -

Identifier Source: org_study_id