Blood Flow Restriction Following ACLR

Brief Title

Blood Flow Restriction Following ACLR

Official Title

Postoperative Blood Flow Restriction Training Following Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.

Brief Summary

      The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and
      improve strength after ACL reconstruction. It is hypothesized that BFR training will
      significantly reduce muscle loss and improve strength after ACL reconstruction. It is also
      hypothesized that BFR will result in improved patient reported outcomes and rates of return
      to sport.
    

Detailed Description

      Following anterior cruciate ligament (ACL) reconstruction, many patients experience weakness
      of the quadriceps (thigh muscles) and loss of muscle mass due to inactivity following
      surgery. Recent research has demonstrated that blood flow restriction (BFR) training can help
      reduce the loss of muscle mass and strength after surgery. Blood flow restriction training
      uses an inflatable cuff that prevents blood from flowing out of the leg while patients
      perform physical therapy exercises. This allows patients to use lighter weights while
      reducing muscle loss and building strength.

      This will be a prospective, randomized controlled trial of patients undergoing ACL
      reconstruction with bone-patellar tendon-bone (BTB) autograft. Half the subjects will be
      randomly assigned to the BFR group and half will undergo sham BFR therapy after surgery.

      Statistical Assumptions: To sufficiently power (80%) the investigation to detect a difference
      (alpha = 0.05) in quadriceps muscle strength (isokinetic contraction) following the
      completion of the BFR rehabilitation program, 19 subjects per group (38 total) would be
      required. However, accounting for a 20% attrition rate and an additional 20% potentially
      screened out at the time of surgery due to other pathology (i.e. repairable meniscus tears,
      cartilage defects, etc.) that alters the prescribed physical therapy protocol, this study
      will aim to recruit and enroll 54 subjects (27 per group).

      Following ACL reconstruction surgery, subjects will complete a standardized postoperative
      rehabilitation program with or without BFR. The rehabilitation program will be broken into 4
      phases including (1) protection, range of motion, and proprioception; (2) strength and
      endurance; (3) power and agility; and (4) return to sport training. Physical therapy will
      occur 2 times per week for 20 weeks. Subjects will attend follow-up visits at 1, 3, 6, and 12
      months. Physical exam and muscle mass measurements will be performed at all visits, while
      strength testing will be performed at 3, 6, and 12 months.

      The goal of this study is to determine the efficacy of BFR therapy in improving muscle
      strength and reducing loss of muscle mass following ACL reconstruction, in addition to
      determining the effect of BFR on patient reported outcomes and return to sport. It is
      anticipated that BFR will significantly reduce the loss of muscle mass and improve muscular
      strength compared to standard therapy. It is also expected that these subjects will have
      improved patient reported outcomes and greater rates of return to sport.
    


Study Type

Interventional


Primary Outcome

Muscle strength


Condition

Anterior Cruciate Ligament Injuries

Intervention

Blood Flow Restriction Training

Study Arms / Comparison Groups

 Sham Postoperative Rehabilitation
Description:  Patients in this group will complete the standardized postoperative rehabilitation program with sham BFR, which is pressure of 20 mmHG. Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set. The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

54

Start Date

June 2020

Completion Date

June 2021

Primary Completion Date

June 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients 18-40

          -  English-speaking

          -  Primary ACL Reconstruction

          -  No associated procedures (meniscal repair, other ligamentous pathology), or history of
             deep vein thrombosis.

          -  Clinical and radiographic examination (MRI) consistent with an acute full thickness
             ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft

          -  Written and informed consent for study participation

        Exclusion Criteria:

          -  Patients younger than 18 or older than 40 years of age

          -  Non-native English speaker

          -  Revision surgery or prior history of knee surgery

          -  Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative
             weight bearing status or rehabilitation protocol

          -  Inability to comply with the proposed follow-up clinic visits

          -  Patients lacking decisional capacity

          -  Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting
             disorder or hypercoagulable state

          -  Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test
             prior to procedure. Females of childbearing potential must agree to use an acceptable
             birth control method during study participation.

          -  Worker's compensation patients

          -  Any clinically significant finding that would place the patient at health risk, impact
             the study, or affect the completion of the study

          -  Any psychiatric illness that would prevent comprehension of the details and nature of
             the study and interfere with follow-up clinic visits
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Administrative Informations


NCT ID

NCT04086030

Organization ID

19050802


Responsible Party

Sponsor

Study Sponsor

Rush University Medical Center


Study Sponsor

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Verification Date

March 2020