Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
Condition: ACL Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

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.
    

Intervention name(s): Blood flow restriction (BFR)
Intervention type(s): Device
Intervention description(s): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.
Masking: None (Open Label)
Primary purpose: Treatment