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
|Condition or disease||Intervention/treatment||Phase|
|ACL Tear||Device: Blood flow restriction (BFR)||Not Applicable|
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 .
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|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)|
|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|
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.
- 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®)
- 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®)
- 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®)
- 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)
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
|Principal Investigator:||Patrick McCulloch, MD||The Methodist Hospital Research Institute|