<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484961</url>
  </required_header>
  <id_info>
    <org_study_id>Pro000138201</org_study_id>
    <nct_id>NCT04484961</nct_id>
  </id_info>
  <brief_title>Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction</brief_title>
  <official_title>Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Methodist Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Methodist Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective randomized control trial consisting of subjects requiring ACL&#xD;
      reconstruction with BTB autograft. Subjects were randomly divided into two groups following&#xD;
      their inclusion in the study. One group underwent the normal ACL rehab protocol as determined&#xD;
      by the participating surgeons. The study group underwent normal ACL rehab modified by use of&#xD;
      a tourniquet for blood flow restriction during selected exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On the day of the procedure, the surgeon will measure the subject's thigh circumference 1/3&#xD;
      distance from the superior pole of the patella to the inguinal crease. The subject will then&#xD;
      undergo the normal BTB autograft ACL reconstruction procedure. A subject will be excluded&#xD;
      from the study if a meniscal repair is performed. At the subject's two week post-operative&#xD;
      clinic visit, the physician will measure thigh circumference at 1/3 distance from the&#xD;
      superior pole of the patella to the inguinal crease. Study group subjects will begin physical&#xD;
      therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be&#xD;
      taken through normal ACL rehab protocol as well as BFR exercises. Control group subjects will&#xD;
      do the same exercises and formal physical therapy rehab protocol as the study group without&#xD;
      BFR.&#xD;
&#xD;
      The BFR exercises will consist of: bilateral leg press week 3-10, eccentric leg press weeks&#xD;
      4-10, hamstring curl week 4-6, eccentric hamstring curl weeks 7-10, straight leg press weeks&#xD;
      6-10. The pressure used will be elevated to occluded blood flow by 80% (80% occlusion&#xD;
      pressure) which will be determined for each individual subject. Subjects will do exercises at&#xD;
      20% of 1RM in 4 sets of 30-15-15-15 repetitions separated by 30 seconds of rest. Repetition&#xD;
      maximum (1RM) will be determined by the contralateral leg, using the greatest amount of&#xD;
      weight with full range of motion and proper form. This will be done over three separate&#xD;
      tries, separated by one minute breaks. Resistance loads will be adjusted every 2 weeks as&#xD;
      strength improves. During the exercise protocol, if patients are unable to complete the&#xD;
      prescribed amount of repetitions, rest periods between sets will be increased as needed. The&#xD;
      control group will do these exercises without BFR. Both study and control groups will also do&#xD;
      the surgeons' standard post-ACL reconstruction physical therapy protocol.&#xD;
&#xD;
      Cuff pressures will be determined using the Loenneke et al outline, based off of thigh&#xD;
      circumference and estimated cuff pressure for 50% artery occlusion [19].&#xD;
&#xD;
      Body composition (DEXA), bone density (DEXA), IKDC and Tegner Lysholm scores will be recorded&#xD;
      at first rehabilitation visit, two weeks, eight weeks and 12 weeks following the initiation&#xD;
      of rehab (1 wk following surgery). Y- balance, single leg squat distance, and single leg step&#xD;
      down will be measured at 8 weeks and 12 weeks of rehab. Return to play will be recorded as&#xD;
      the number of months after the day of operation until subject returns to sport.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2016</start_date>
  <completion_date type="Actual">July 10, 2020</completion_date>
  <primary_completion_date type="Actual">July 10, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine if BFR changes loss of LE lean muscle mass</measure>
    <time_frame>Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery</time_frame>
    <description>LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if BFR changes loss of bone mass</measure>
    <time_frame>Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery</time_frame>
    <description>Bone mass was measured in grams using DEXA (iDXA, GE®)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine if BFR changes loss of bone mineral density</measure>
    <time_frame>Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery</time_frame>
    <description>Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does BFR change the number of exercise repetitions in functional physical therapy testing</measure>
    <time_frame>Week 8 and Week 12 post-surgery</time_frame>
    <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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>ACL Tear</condition>
  <arm_group>
    <arm_group_label>Control - Routine Rehab</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group received standard ACL rehab with no blood flow restriction therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental - BFR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood flow restriction (BFR)</intervention_name>
    <description>The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.</description>
    <arm_group_label>Experimental - BFR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-35&#xD;
&#xD;
          -  Received ACL surgery with a patellar tendon autograft&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant meniscal tear or additional ligamentous injury to the knee&#xD;
&#xD;
          -  Obesity (BMI&gt;30)&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cardiovascular, renal, liver or pulmonary disease&#xD;
&#xD;
          -  Active infections&#xD;
&#xD;
          -  Cancer (current or treated within the past 2 years) or coagulation disorder&#xD;
&#xD;
          -  Rapid weight change within the past year&#xD;
&#xD;
          -  Physically unable to participate in the intervention&#xD;
&#xD;
          -  Are not currently taking, or recently (w/in 1month of participation) taken prescribed&#xD;
             or over the counter ergogenic aids or compounds known to be banned by the NCAA. The&#xD;
             NCAA banned substances list can be viewed from:&#xD;
             http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs&#xD;
&#xD;
          -  Unable to complete a minimum of 85% of the assigned rehabilitation sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick McCulloch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Methodist Hospital Research Institute</affiliation>
  </overall_official>
  <reference>
    <citation>Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8. Erratum In: J Appl Physiol. 2008 Apr;104(4):1255.</citation>
    <PMID>16339340</PMID>
  </reference>
  <reference>
    <citation>Abe T, Sakamaki M, Fujita S, Ozaki H, Sugaya M, Sato Y, Nakajima T. Effects of low-intensity walk training with restricted leg blood flow on muscle strength and aerobic capacity in older adults. J Geriatr Phys Ther. 2010 Jan-Mar;33(1):34-40.</citation>
    <PMID>20503732</PMID>
  </reference>
  <reference>
    <citation>Abe T, Yasuda T, Midorikawa T, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily &quot;KAATSU&quot; resistance training. Int J KAATSU Train Res. 2005;1(1):6-12</citation>
  </reference>
  <reference>
    <citation>Anderson AW, Smith JJ. Proximal tibial fracture after patellar tendon autograft for ipsilateral ACL reconstruction. J Knee Surg. 2009 Apr;22(2):142-4. doi: 10.1055/s-0030-1247739.</citation>
    <PMID>19476179</PMID>
  </reference>
  <reference>
    <citation>Anderson MJ, Diko S, Baehr LM, Baar K, Bodine SC, Christiansen BA. Contribution of mechanical unloading to trabecular bone loss following non-invasive knee injury in mice. J Orthop Res. 2016 Oct;34(10):1680-1687. doi: 10.1002/jor.23178. Epub 2016 Feb 10.</citation>
    <PMID>26826014</PMID>
  </reference>
  <reference>
    <citation>Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.</citation>
    <PMID>21098818</PMID>
  </reference>
  <reference>
    <citation>Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.</citation>
    <PMID>28251287</PMID>
  </reference>
  <reference>
    <citation>Bowman EN, El-shaar R, Milligan H, et al. The Proximal and Distal Effects of Blood Flow Restriction Therapy on Upper and Lower Extremity Strengthening: A Randomized Controlled Trial. Orthop J Sports Med. 2019;7(7_suppl5):2325967119S2325900337.</citation>
  </reference>
  <reference>
    <citation>Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.</citation>
    <PMID>17909396</PMID>
  </reference>
  <reference>
    <citation>Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.</citation>
    <PMID>26446893</PMID>
  </reference>
  <reference>
    <citation>Elkasrawy M, Immel D, Wen X, Liu X, Liang LF, Hamrick MW. Immunolocalization of myostatin (GDF-8) following musculoskeletal injury and the effects of exogenous myostatin on muscle and bone healing. J Histochem Cytochem. 2012 Jan;60(1):22-30. doi: 10.1369/0022155411425389.</citation>
    <PMID>22205678</PMID>
  </reference>
  <reference>
    <citation>Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.</citation>
    <PMID>20150565</PMID>
  </reference>
  <reference>
    <citation>Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.</citation>
    <PMID>28500081</PMID>
  </reference>
  <reference>
    <citation>Hamrick MW. A role for myokines in muscle-bone interactions. Exerc Sport Sci Rev. 2011 Jan;39(1):43-7. doi: 10.1097/JES.0b013e318201f601.</citation>
    <PMID>21088601</PMID>
  </reference>
  <reference>
    <citation>Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.</citation>
    <PMID>29879638</PMID>
  </reference>
  <reference>
    <citation>Lambert B, Hedt C, Epner E, et al. BFR For Proximal Benefit: Blood Flow Restriction Therapy For The Shoulder? Med Sci Sports Exerc. 2019;51(6):972-973.</citation>
  </reference>
  <reference>
    <citation>Lambert B, Hedt CA, Jack RA, et al. Blood flow restriction therapy preserves whole limb bone and muscle following ACL reconstruction. Orthop J Sports Med. 2019;7(3_suppl2):2325967119S2325900196.</citation>
  </reference>
  <reference>
    <citation>Lambert BS, Hedt C, Moreno M, Harris JD, McCulloch P. Blood Flow Restriction Therapy for Stimulating Skeletal Muscle Growth: Practical Considerations for Maximizing Recovery in Clinical Rehabilitation Settings. Tech Orthop. 2018;33(2):89-97.</citation>
  </reference>
  <reference>
    <citation>Lambert BS, Shimkus KL, Fluckey JD, Riechman SE, Greene NP, Cardin JM, Crouse SF. Anabolic responses to acute and chronic resistance exercise are enhanced when combined with aquatic treadmill exercise. Am J Physiol Endocrinol Metab. 2015 Feb 1;308(3):E192-200. doi: 10.1152/ajpendo.00689.2013. Epub 2014 Nov 25.</citation>
    <PMID>25425002</PMID>
  </reference>
  <reference>
    <citation>Loenneke JP, Kim D, Fahs CA, Thiebaud RS, Abe T, Larson RD, Bemben DA, Bemben MG. Effects of exercise with and without different degrees of blood flow restriction on torque and muscle activation. Muscle Nerve. 2015 May;51(5):713-21. doi: 10.1002/mus.24448.</citation>
    <PMID>25187395</PMID>
  </reference>
  <reference>
    <citation>Mundermann A, Payer N, Felmet G, Riehle H. Comparison of volumetric bone mineral density in the operated and contralateral knee after anterior cruciate ligament and reconstruction: A 1-year follow-up study using peripheral quantitative computed tomography. J Orthop Res. 2015 Dec;33(12):1804-10. doi: 10.1002/jor.22962. Epub 2015 Jul 14.</citation>
    <PMID>26123943</PMID>
  </reference>
  <reference>
    <citation>Patterson SD, Brandner CR. The role of blood flow restriction training for applied practitioners: A questionnaire-based survey. J Sports Sci. 2018 Jan;36(2):123-130. doi: 10.1080/02640414.2017.1284341. Epub 2017 Feb 1.</citation>
    <PMID>28143359</PMID>
  </reference>
  <reference>
    <citation>Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.</citation>
  </reference>
  <reference>
    <citation>Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.</citation>
    <PMID>25430600</PMID>
  </reference>
  <reference>
    <citation>Swift JM, Nilsson MI, Hogan HA, Sumner LR, Bloomfield SA. Simulated resistance training during hindlimb unloading abolishes disuse bone loss and maintains muscle strength. J Bone Miner Res. 2010 Mar;25(3):564-74. doi: 10.1359/jbmr.090811.</citation>
    <PMID>19653816</PMID>
  </reference>
  <reference>
    <citation>Thangamani VB, Flanigan DC, Merk BR. Intra-articular distal femur fracture extending from an expanded femoral tunnel in an anterior cruciate ligament (ACL) reconstructed knee: a case report. J Trauma. 2009 Dec;67(6):E209-12. doi: 10.1097/TA.0b013e3181469f42.</citation>
    <PMID>19065114</PMID>
  </reference>
  <reference>
    <citation>Vechin FC, Libardi CA, Conceicao MS, Damas FR, Lixandrao ME, Berton RP, Tricoli VA, Roschel HA, Cavaglieri CR, Chacon-Mikahil MP, Ugrinowitsch C. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015 Apr;29(4):1071-6. doi: 10.1519/JSC.0000000000000703.</citation>
    <PMID>25264670</PMID>
  </reference>
  <reference>
    <citation>Wright R, Spindler K, Huston L, Amendola A, Andrish J, Brophy R, Carey J, Cox C, Flanigan D, Jones M, Kaeding C, Marx R, Matava M, McCarty E, Parker R, Vidal A, Wolcott M, Wolf B, Dunn W. Revision ACL reconstruction outcomes: MOON cohort. J Knee Surg. 2011 Dec;24(4):289-94. doi: 10.1055/s-0031-1292650.</citation>
    <PMID>22303759</PMID>
  </reference>
  <reference>
    <citation>Yamanaka T, Farley RS, Caputo JL. Occlusion training increases muscular strength in division IA football players. J Strength Cond Res. 2012 Sep;26(9):2523-9. doi: 10.1519/JSC.0b013e31823f2b0e.</citation>
    <PMID>22105051</PMID>
  </reference>
  <reference>
    <citation>Zargi T, Drobnic M, Strazar K, Kacin A. Short-Term Preconditioning With Blood Flow Restricted Exercise Preserves Quadriceps Muscle Endurance in Patients After Anterior Cruciate Ligament Reconstruction. Front Physiol. 2018 Aug 24;9:1150. doi: 10.3389/fphys.2018.01150. eCollection 2018.</citation>
    <PMID>30197599</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Methodist Hospital Research Institute</investigator_affiliation>
    <investigator_full_name>Patrick McCulloch</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 18, 2022</submitted>
    <returned>March 18, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484961
org study id: Pro000138201
nct id: NCT04484961
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Determine if BFR changes loss of LE lean muscle mass
time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
description: LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)
measure: Determine if BFR changes loss of bone mass
time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
description: Bone mass was measured in grams using DEXA (iDXA, GE®)
measure: Determine if BFR changes loss of bone mineral density
time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
description: Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
measure: Does BFR change the number of exercise repetitions in functional physical therapy testing
time frame: Week 8 and Week 12 post-surgery
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)
arm group label: Control - Routine Rehab
arm group type: No Intervention
description: Participants in this group received standard ACL rehab with no blood flow restriction therapy.
arm group label: Experimental - BFR
arm group type: Experimental
description: Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
intervention type: Device
intervention name: Blood flow restriction (BFR)
description: The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
arm group label: Experimental - BFR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick McCulloch, MD
role: Principal Investigator
affiliation: The Methodist Hospital Research Institute
citation: Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8. Erratum In: J Appl Physiol. 2008 Apr;104(4):1255.
PMID: 16339340
citation: Abe T, Sakamaki M, Fujita S, Ozaki H, Sugaya M, Sato Y, Nakajima T. Effects of low-intensity walk training with restricted leg blood flow on muscle strength and aerobic capacity in older adults. J Geriatr Phys Ther. 2010 Jan-Mar;33(1):34-40.
PMID: 20503732
citation: Abe T, Yasuda T, Midorikawa T, et al. Skeletal muscle size and circulating IGF-1 are increased after two weeks of twice daily "KAATSU" resistance training. Int J KAATSU Train Res. 2005;1(1):6-12
citation: Anderson AW, Smith JJ. Proximal tibial fracture after patellar tendon autograft for ipsilateral ACL reconstruction. J Knee Surg. 2009 Apr;22(2):142-4. doi: 10.1055/s-0030-1247739.
PMID: 19476179
citation: Anderson MJ, Diko S, Baehr LM, Baar K, Bodine SC, Christiansen BA. Contribution of mechanical unloading to trabecular bone loss following non-invasive knee injury in mice. J Orthop Res. 2016 Oct;34(10):1680-1687. doi: 10.1002/jor.23178. Epub 2016 Feb 10.
PMID: 26826014
citation: Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.
PMID: 21098818
citation: Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyere O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1.
PMID: 28251287
citation: Bowman EN, El-shaar R, Milligan H, et al. The Proximal and Distal Effects of Blood Flow Restriction Therapy on Upper and Lower Extremity Strengthening: A Randomized Controlled Trial. Orthop J Sports Med. 2019;7(7_suppl5):2325967119S2325900337.
citation: Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.
PMID: 17909396
citation: Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
PMID: 26446893
citation: Elkasrawy M, Immel D, Wen X, Liu X, Liang LF, Hamrick MW. Immunolocalization of myostatin (GDF-8) following musculoskeletal injury and the effects of exogenous myostatin on muscle and bone healing. J Histochem Cytochem. 2012 Jan;60(1):22-30. doi: 10.1369/0022155411425389.
PMID: 22205678
citation: Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PMID: 20150565
citation: Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.
PMID: 28500081
citation: Hamrick MW. A role for myokines in muscle-bone interactions. Exerc Sport Sci Rev. 2011 Jan;39(1):43-7. doi: 10.1097/JES.0b013e318201f601.
PMID: 21088601
citation: Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.
PMID: 29879638
citation: Lambert B, Hedt C, Epner E, et al. BFR For Proximal Benefit: Blood Flow Restriction Therapy For The Shoulder? Med Sci Sports Exerc. 2019;51(6):972-973.
citation: Lambert B, Hedt CA, Jack RA, et al. Blood flow restriction therapy preserves whole limb bone and muscle following ACL reconstruction. Orthop J Sports Med. 2019;7(3_suppl2):2325967119S2325900196.
citation: Lambert BS, Hedt C, Moreno M, Harris JD, McCulloch P. Blood Flow Restriction Therapy for Stimulating Skeletal Muscle Growth: Practical Considerations for Maximizing Recovery in Clinical Rehabilitation Settings. Tech Orthop. 2018;33(2):89-97.
citation: Lambert BS, Shimkus KL, Fluckey JD, Riechman SE, Greene NP, Cardin JM, Crouse SF. Anabolic responses to acute and chronic resistance exercise are enhanced when combined with aquatic treadmill exercise. Am J Physiol Endocrinol Metab. 2015 Feb 1;308(3):E192-200. doi: 10.1152/ajpendo.00689.2013. Epub 2014 Nov 25.
PMID: 25425002
citation: Loenneke JP, Kim D, Fahs CA, Thiebaud RS, Abe T, Larson RD, Bemben DA, Bemben MG. Effects of exercise with and without different degrees of blood flow restriction on torque and muscle activation. Muscle Nerve. 2015 May;51(5):713-21. doi: 10.1002/mus.24448.
PMID: 25187395
citation: Mundermann A, Payer N, Felmet G, Riehle H. Comparison of volumetric bone mineral density in the operated and contralateral knee after anterior cruciate ligament and reconstruction: A 1-year follow-up study using peripheral quantitative computed tomography. J Orthop Res. 2015 Dec;33(12):1804-10. doi: 10.1002/jor.22962. Epub 2015 Jul 14.
PMID: 26123943
citation: Patterson SD, Brandner CR. The role of blood flow restriction training for applied practitioners: A questionnaire-based survey. J Sports Sci. 2018 Jan;36(2):123-130. doi: 10.1080/02640414.2017.1284341. Epub 2017 Feb 1.
PMID: 28143359
citation: Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.
citation: Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.
PMID: 25430600
citation: Swift JM, Nilsson MI, Hogan HA, Sumner LR, Bloomfield SA. Simulated resistance training during hindlimb unloading abolishes disuse bone loss and maintains muscle strength. J Bone Miner Res. 2010 Mar;25(3):564-74. doi: 10.1359/jbmr.090811.
PMID: 19653816
citation: Thangamani VB, Flanigan DC, Merk BR. Intra-articular distal femur fracture extending from an expanded femoral tunnel in an anterior cruciate ligament (ACL) reconstructed knee: a case report. J Trauma. 2009 Dec;67(6):E209-12. doi: 10.1097/TA.0b013e3181469f42.
PMID: 19065114
citation: Vechin FC, Libardi CA, Conceicao MS, Damas FR, Lixandrao ME, Berton RP, Tricoli VA, Roschel HA, Cavaglieri CR, Chacon-Mikahil MP, Ugrinowitsch C. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015 Apr;29(4):1071-6. doi: 10.1519/JSC.0000000000000703.
PMID: 25264670
citation: Wright R, Spindler K, Huston L, Amendola A, Andrish J, Brophy R, Carey J, Cox C, Flanigan D, Jones M, Kaeding C, Marx R, Matava M, McCarty E, Parker R, Vidal A, Wolcott M, Wolf B, Dunn W. Revision ACL reconstruction outcomes: MOON cohort. J Knee Surg. 2011 Dec;24(4):289-94. doi: 10.1055/s-0031-1292650.
PMID: 22303759
citation: Yamanaka T, Farley RS, Caputo JL. Occlusion training increases muscular strength in division IA football players. J Strength Cond Res. 2012 Sep;26(9):2523-9. doi: 10.1519/JSC.0b013e31823f2b0e.
PMID: 22105051
citation: Zargi T, Drobnic M, Strazar K, Kacin A. Short-Term Preconditioning With Blood Flow Restricted Exercise Preserves Quadriceps Muscle Endurance in Patients After Anterior Cruciate Ligament Reconstruction. Front Physiol. 2018 Aug 24;9:1150. doi: 10.3389/fphys.2018.01150. eCollection 2018.
PMID: 30197599
responsible party type: Principal Investigator
investigator affiliation: The Methodist Hospital Research Institute
investigator full name: Patrick McCulloch
investigator title: Principal investigator
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No
submitted: January 18, 2022
returned: March 18, 2022