The Effect of Various Strength Training Protocols in ACL Reconstructed Participants
Condition: Anterior Cruciate Ligament (ACL) Tear; Physical Therapy
Study type: Interventional

Summary: 
      The purpose of the study is to determine how two different blood flow restriction training
      programs used in conjunction with standard rehabilitation affect leg strength. By doing this
      study, the investigator hopes to learn if one program improves strength and function more
      than the other. The investigator also hope to learn how the training affects the properties
      of muscle in participants who will or have had anterior cruciate ligament (ACL)
      reconstruction. These results will help define how the training programs are working.

      There will be no charge to the participant for their physical therapy visits as long as they
      are part of the study

      The initial visit and follow up assessment at the end of the training will each take up to 6
      hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and
      questionaires).

      The physical therapy visits will range from 60-120 minutes depending on the participant's
      stage of recovery and the activities to engage in. Training sessions will be held 3 days a
      week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be
      a total of 4 additional study visits over a 7 month period. The first visit will be used to
      capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength).
      The second visit will occur right before surgery to assess changes during prehabilitation
      (strength and walking mechanics). The third visit will occur 4-5 months after surgery and
      will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI,
      strength, gait). The last visit will occur 6-7 months after surgery and will involve an
      assessment of their thigh muscle strength, walking, and jumping form.

      The muscle biopsy and magnetic resonance imaging portion of the study will occur in the
      outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center
      and the MRI center located on the medical center campus. The muscle biopsy will take an
      additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours
      total to complete both procedures. The investigator will accommodate participant preference
      for scheduling.
    

Detailed description: 
      The following procedures may be performed.

      Training sessions: Participants will be randomly assigned one of two groups. Assignments to
      which group are determined by random assignment based upon participant's number. One group
      will receive standard of care and the other will receive standard of care plus blood flow
      restriction training.

      The air bands will then be placed on the participant's thighs and they will be doing a
      standardized exercise program that will vary depending on the stage of rehabilitation they
      are in and as determined by the study personnel. Participants will also complete a
      standardized course of physical therapy. Activities in physical therapy may include ice over
      the knee, range of motion exercises to maintain hip strength and gait training exercises as
      needed and as the participant's impairments dictate. The investigator will also provide an
      educational program at regular intervals on the injury and recovery.

      Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will
      be placed around the thigh. A second strap will be placed around the bottom of their lower
      leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will
      control movements and apply force at several different speeds and in a isometric mode.

      Motion Analysis: Motion analysis will provide a means for evaluating motion of the
      participant's hip, knee and ankle joints during walking and jogging on the treadmill.
      Participants will have reflective markers placed on certain landmarks of their legs and lower
      back to allow the motion analysis system to record their trunk, hip, knee, and ankle
      movements. Markers will be applied with sticky tape to the skin and if necessary, athletic
      tape to limit marker movement during activities. A stationary trial will be collected to help
      the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds
      every minute. Participants will perform a series of jumps on both legs and on a single leg.
      In addition participants will be asked to go up and down step.

      Treadmill Activity: Participants may walk on the treadmill as long as necessary to feel
      comfortable with it. Once ready, participants will walk at a self-selected warm up pace for 5
      minutes. The investigator will then gradually increase the speed 1.5 m/s for 2 minutes each.
      The speed of the treadmill will then be increased gradually to a self-selected comfortable
      jogging\running pace for 2 minutes. Participants may request to stop at any time.

      Muscle Biopsy: A small piece of muscle tissue will be removed from both of thighs. The muscle
      tissue will be taken from the outside of your thigh and will be taken about one hand width
      above your knee. A 1 inch by 1 inch portion of hair will possibly need to be shaved if
      necessary. The area of thigh will be numbed and a small ¼ inch incision will be made in the
      skin. A needle will then be briefly (lasting just a couple of seconds) inserted into the
      muscle to remove a .005 ounce piece of muscle (about the size of a pencil eraser). The
      incision will be pulled closed with a band-aid after the site is cleaned with an alcohol
      preparation and the participant's leg will be wrapped snugly with an elastic bandage. The
      procedure will last approximately 15 minutes. The tissue samples will be used in the analysis
      process. In addition, standard venipuncture methods will be used to collect one 7.5 mL tube
      of blood to be used for analysis.

      Magnetic Resonance Imaging & Spectroscopy Center: Participants will be asked to complete a
      medical screening questionnaire that will ask specific questions about their health and
      medical history. This information will be used to determine eligibility to participate in the
      study. At this time, the procedures and risks involved in participating in the research study
      will be explained to the individual. Participants will also fill out a questionnaire asking
      whether they have any metal in their body as well as any other medical conditions that may
      need to be considered before they enter the MRI scanner. The metal screening questionnaire
      will be reviewed by the individual operating the scanner and if any risks are identified, the
      participant may not be able to participate.

      Participants will be taken to the MRI scanner by the experimenter. Participants will be asked
      to remove all jewelry, body piercings, hair accessories, belts, wallets, credit cards, and
      loose change and leave these items with the experimenter. Participants will then be
      instructed about specific MRI procedures.

      The magnetic resonance scanning will take approximately 60 minutes per leg. Participants will
      be asked to lie still during the scanning.
    

Intervention name(s): Arm A - blood flow restriction training; Arm B - standard of care
Intervention type(s): Other; Other
Intervention description(s): Group receive standard of care plus blood flow restriction training; Group will receive standard of care plus a sham version of blood flow restriction training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment