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Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

Primary Purpose

ACL Tear

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood flow restriction (BFR)
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Tear

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 18-35
  • Received ACL surgery with a patellar tendon autograft

Exclusion Criteria:

  • Concomitant meniscal tear or additional ligamentous injury to the knee
  • Obesity (BMI>30)
  • Diabetes
  • Cardiovascular, renal, liver or pulmonary disease
  • Active infections
  • Cancer (current or treated within the past 2 years) or coagulation disorder
  • Rapid weight change within the past year
  • Physically unable to participate in the intervention
  • Are not currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA. The NCAA banned substances list can be viewed from: http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs
  • Unable to complete a minimum of 85% of the assigned rehabilitation sessions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control - Routine Rehab

    Experimental - BFR

    Arm Description

    Participants in this group received standard ACL rehab with no blood flow restriction therapy.

    Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.

    Outcomes

    Primary Outcome Measures

    Determine if BFR changes loss of LE lean muscle mass
    LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)
    Determine if BFR changes loss of bone mass
    Bone mass was measured in grams using DEXA (iDXA, GE®)
    Determine if BFR changes loss of bone mineral density
    Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)

    Secondary Outcome Measures

    Does BFR change the number of exercise repetitions in functional physical therapy testing
    Single leg (SL) squat (best of 3 attempts), SL eccentric step down (reps to fatigue or inadequate technique), Y-balance11,51 (best of 3 attempts), SL leg press (1RM), and SL hamstring curl (1RM)

    Full Information

    First Posted
    July 13, 2020
    Last Updated
    July 23, 2020
    Sponsor
    The Methodist Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04484961
    Brief Title
    Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
    Official Title
    Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 18, 2016 (Actual)
    Primary Completion Date
    July 10, 2020 (Actual)
    Study Completion Date
    July 10, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Methodist Hospital Research Institute

    4. Oversight

    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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
    Detailed Description
    On the day of the procedure, the surgeon will measure the subject's thigh circumference 1/3 distance from the superior pole of the patella to the inguinal crease. The subject will then undergo the normal BTB autograft ACL reconstruction procedure. A subject will be excluded from the study if a meniscal repair is performed. At the subject's two week post-operative clinic visit, the physician will measure thigh circumference at 1/3 distance from the superior pole of the patella to the inguinal crease. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal ACL rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR. The BFR exercises will consist of: bilateral leg press week 3-10, eccentric leg press weeks 4-10, hamstring curl week 4-6, eccentric hamstring curl weeks 7-10, straight leg press weeks 6-10. The pressure used will be elevated to occluded blood flow by 80% (80% occlusion pressure) which will be determined for each individual subject. Subjects will do exercises at 20% of 1RM in 4 sets of 30-15-15-15 repetitions separated by 30 seconds of rest. Repetition maximum (1RM) will be determined by the contralateral leg, using the greatest amount of weight with full range of motion and proper form. This will be done over three separate tries, separated by one minute breaks. Resistance loads will be adjusted every 2 weeks as strength improves. During the exercise protocol, if patients are unable to complete the prescribed amount of repetitions, rest periods between sets will be increased as needed. The control group will do these exercises without BFR. Both study and control groups will also do the surgeons' standard post-ACL reconstruction physical therapy protocol. Cuff pressures will be determined using the Loenneke et al outline, based off of thigh circumference and estimated cuff pressure for 50% artery occlusion [19]. Body composition (DEXA), bone density (DEXA), IKDC and Tegner Lysholm scores will be recorded at first rehabilitation visit, two weeks, eight weeks and 12 weeks following the initiation of rehab (1 wk following surgery). Y- balance, single leg squat distance, and single leg step down will be measured at 8 weeks and 12 weeks of rehab. Return to play will be recorded as the number of months after the day of operation until subject returns to sport.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Tear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control - Routine Rehab
    Arm Type
    No Intervention
    Arm Description
    Participants in this group received standard ACL rehab with no blood flow restriction therapy.
    Arm Title
    Experimental - BFR
    Arm Type
    Experimental
    Arm Description
    Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Blood flow restriction (BFR)
    Intervention Description
    The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
    Primary Outcome Measure Information:
    Title
    Determine if BFR changes loss of LE lean muscle mass
    Description
    LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)
    Time Frame
    Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
    Title
    Determine if BFR changes loss of bone mass
    Description
    Bone mass was measured in grams using DEXA (iDXA, GE®)
    Time Frame
    Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
    Title
    Determine if BFR changes loss of bone mineral density
    Description
    Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
    Time Frame
    Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
    Secondary Outcome Measure Information:
    Title
    Does BFR change the number of exercise repetitions in functional physical therapy testing
    Description
    Single leg (SL) squat (best of 3 attempts), SL eccentric step down (reps to fatigue or inadequate technique), Y-balance11,51 (best of 3 attempts), SL leg press (1RM), and SL hamstring curl (1RM)
    Time Frame
    Week 8 and Week 12 post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ages 18-35 Received ACL surgery with a patellar tendon autograft Exclusion Criteria: Concomitant meniscal tear or additional ligamentous injury to the knee Obesity (BMI>30) Diabetes Cardiovascular, renal, liver or pulmonary disease Active infections Cancer (current or treated within the past 2 years) or coagulation disorder Rapid weight change within the past year Physically unable to participate in the intervention Are not currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA. The NCAA banned substances list can be viewed from: http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs Unable to complete a minimum of 85% of the assigned rehabilitation sessions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick McCulloch, MD
    Organizational Affiliation
    The Methodist Hospital Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

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