Blood Flow Restriction Following ACL Reconstruction (BFR)

November 30, 2022 updated by: Edward Chang, MD, Inova Health Care Services

The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction

The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.

Study Overview

Status

Status

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

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

Recovery from anterior cruciate ligament (ACL) reconstruction involves early physical therapy to promote muscular development. Traditional training regimens are based on the concept that muscle growth is induced with high resistance exercises of at least 65-70% of 1-repetition maximum. Achieving a high resistance level can be challenging in the early post-surgical patient who may be limited by pain, muscle atrophy, diminished proprioception, and psychological factors. Increasing evidence has suggested that Blood Flow Restriction (BFR) in resistance training, while transmitting a decreased load (25-50% of 1-repetition maximum) across the surgical site, may provide an additional benefit of inducing muscular development similar to that of high intensity exercises .

Augmenting exercises with BFR involves an external pressure cuff applied to the proximal portion of the extremity, which is inflated to a pressure that restricts venous outflow while allowing arterial inflow to continue. This creates a physiologic environment for the patient to gain the hypertrophic effect of high resistance training, though at a lower and safer intensity. Studies suggest that BFR stimulates muscular development through an increase in metabolic stress, muscle fiber recruitment, cell swelling, and protein synthesis.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

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
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Health System

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

9 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 13-35 years at the time of surgery
  2. Anterior Cruciate Ligament (ACL) reconstruction
  3. Using a physical therapy center with Blood Flow Restriction capabilities.

Exclusion Criteria:

  1. Concomitant ligament reconstruction
  2. Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
  3. History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
  4. Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
  5. History of coagulation disorders or current use of anticoagulants
  6. Completion of physical therapy at a location not affiliated with the study
  7. Pregnancy

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: BFR Therapy
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Device: Blood Flow Restriction Therapy
A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
Other: ACL Reconstruction rehabilitation
post-operative rehabilitation according to current standards of care
Active Comparator: No BFR
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
Other: ACL Reconstruction rehabilitation
post-operative rehabilitation according to current standards of care

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
International Knee Documentation Committee (IKDC) Questionnaire Score
Time Frame: Measured preoperatively and at 12 weeks post-op.
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Measured preoperatively and at 12 weeks post-op.
Visual Analog Score
Time Frame: Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
Quadriceps Tendon Strength
Time Frame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Thigh Circumference
Time Frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of Knee Flexion
Time Frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of Knee Extension
Time Frame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 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
Adverse Effects
Time Frame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op
Observation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.
Tracked from initiation of therapy 2 weeks post-op through 12 weeks 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.
Inova Health Care Services

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: Edward Chang, MD, Orthopedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 1, 2018

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.
November 1, 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.
October 26, 2022

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).
November 14, 2018

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.
November 28, 2018

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.
November 29, 2018

Study Record Updates

Last Update Posted (Estimate)

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.
December 22, 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.
November 30, 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.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 18-3150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Anterior Cruciate Ligament Rupture

Clinical Trials on Blood Flow Restriction Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings