Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

ACL Tear Clinical Trial

Official title:

Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484961
• Other study ID #: Pro000138201
• Status: Completed
• Phase: N/A
• Start date: March 18, 2016
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

References & Publications (30)

Žargi T, Drobnic M, Stražar 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. — View 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. Epub 2005 Dec 8. Erratum in: J Appl Physiol. 2008 Apr;104(4):1255. — View 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. — View 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

Anderson AW, Smith JJ. Proximal tibial fracture after patellar tendon autograft for ipsilateral ACL reconstruction. J Knee Surg. 2009 Apr;22(2):142-4. — View 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. — View 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. — View Citation

Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyère 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. Review. — View 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.

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

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.

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. — View 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. — View Citation

Mündermann 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. — View 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. — View Citation

Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.

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. Review. — View 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. — View 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. — View Citation

Vechin FC, Libardi CA, Conceição MS, Damas FR, Lixandrão 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. — View 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. — View 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. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if BFR changes loss of LE lean muscle mass	LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)	Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Primary	Determine if BFR changes loss of bone mass	Bone mass was measured in grams using DEXA (iDXA, GE®)	Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Primary	Determine if BFR changes loss of bone mineral density	Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)	Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Secondary	Does BFR change the number of exercise repetitions in functional physical therapy testing	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)	Week 8 and Week 12 post-surgery