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Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT04484961
Recruitment Status : Completed
First Posted : July 24, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Patrick McCulloch, The Methodist Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
ACL Tear Device: Blood flow restriction (BFR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Official Title: Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : March 18, 2016
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control - Routine Rehab
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
Experimental: Experimental - BFR
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Device: Blood flow restriction (BFR)
The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.




Primary Outcome Measures :
  1. Determine if BFR changes loss of LE lean muscle mass [ Time Frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery ]
    LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)

  2. Determine if BFR changes loss of bone mass [ Time Frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery ]
    Bone mass was measured in grams using DEXA (iDXA, GE®)

  3. Determine if BFR changes loss of bone mineral density [ Time Frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery ]
    Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)


Secondary Outcome Measures :
  1. Does BFR change the number of exercise repetitions in functional physical therapy testing [ Time Frame: Week 8 and Week 12 post-surgery ]
    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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484961


Sponsors and Collaborators
The Methodist Hospital Research Institute
Investigators
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Principal Investigator: Patrick McCulloch, MD The Methodist Hospital Research Institute
Publications:
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
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.
Korakakis V, Whiteley R, Epameinontidis K. Blood flow restriction-induced analgesia in patients with anterior knee pain. J Sci Med Sport. 2017;20:e100.
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.
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.
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.
Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.

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Responsible Party: Patrick McCulloch, Principal investigator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04484961    
Other Study ID Numbers: Pro000138201
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries