Blood flow restriction (BFR)
DeviceThe study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
NCT Number: NCT04484961
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.
Looking for future studies?
Notify Me18 year–35 year
All sexes
Interventional
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 [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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)
Time frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Bone mass was measured in grams using DEXA (iDXA, GE®)
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®)
Time frame: Week 8 and Week 12 post-surgery
Single leg (SL) squat (best of 3 attempts)
Time frame: 8 weeks post surgery, 12 weeks post surgery
SL eccentric step down (reps to fatigue or inadequate technique)
Time frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance anterior (best of 3 attempts)
Time frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance posteromedial (best of 3 attempts)
Time frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance posterolateral (best of 3 attempts)
Time frame: 8 weeks post surgery, 12 weeks post surgery
SL leg press (1RM)
Time frame: 8 weeks post surgery, 12 weeks post surgery
SL hamstring curl (1RM)
The Methodist Hospital Research Institute
Other
Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07723625
ACL Injury, ACL Tear
Denpasar, Bali, Indonesia
View Trial DetailsNCT07681193
ACL Injury, ACL Tear
Chapel Hill, North Carolina, United States
View Trial DetailsNCT05876013
ACL, ACL Injury
Trondheim, Trøndelag, Norway
View Trial DetailsNCT06340932
ACL Tear, Anterior Cruciate Ligament Injuries
DuBois, Pennsylvania, United States
View Trial Details