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

February 18, 2022 updated by: Norton Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quadriceps Strength
Time Frame: 12 weeks post-op
Quadriceps Strength measured using a handheld dynamoneter
12 weeks post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score, Jr,
Time Frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Knee Injury and Osteoarthritis Outcome Score, Jr,
Pre-Op, 6 and 12 weeks and 12 months post-op
Veterans Rand -12
Time Frame: 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
Time Frame: Pre-Op, 6 and 12 weeks post-op
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
Time Frame: Pre-Op, 6 and 12 weeks and 12 months post-op
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
Time Frame: 6 weeks post-op
Quadriceps Strength measured using a handheld dynamoneter
6 weeks post-op
Quadriceps Strength
Time Frame: 12 months post-op
Quadriceps Strength measured using a handheld dynamoneter
12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norton Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey Stimac, MD, Norton Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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