BFRT vs Standard PT After Total Knee Arthroplasty

NCT04366336 | Withdrawn

• 1 other identifier: 19-N0153
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Blood Flow Restriction Training; Quadriceps Strengthening

Outcome Measures

Primary Outcomes (1)

• Quadriceps Strength

  Quadriceps Strength measured using a handheld dynamoneter

  12 weeks post-op

Secondary Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score, Jr,

  Pre-Op, 6 and 12 weeks and 12 months post-op

• Veterans Rand -12

  Pre-Op, 6 and 12 weeks and 12 months post-op

• Four square Test

  Pre-Op, 6 and 12 weeks post-op

• 5x Sit to Stand Test

  Pre-Op, 6 and 12 weeks and 12 months post-op

• Quadriceps Strength

  6 weeks post-op

Study Arms (2)

Blood Flow Restriction Training

EXPERIMENTAL

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

Standard Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Blood Flow Restriction Training PROCEDURE

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

Blood Flow Restriction Training

Standard Physical Therapy 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

Standard Physical Therapy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norton Healthcare: lead

Study Sites (1)

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jeffrey Stimac, MD

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: February 18, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

US (1)