Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
Primary Purpose
ACL Tear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood flow restriction (BFR)
Sponsored by
About this trial
This is an interventional treatment trial for ACL Tear
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control - Routine Rehab
Experimental - BFR
Arm Description
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Outcomes
Primary Outcome Measures
Determine if BFR changes loss of LE lean muscle mass
LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)
Determine if BFR changes loss of bone mass
Bone mass was measured in grams using DEXA (iDXA, GE®)
Determine if BFR changes loss of bone mineral density
Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04484961
First Posted
July 13, 2020
Last Updated
July 23, 2020
Sponsor
The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04484961
Brief Title
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
Official Title
Effects of Blood Flow Restriction Rehabilitation After Bone Patellar Tendon Bone Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2016 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Routine Rehab
Arm Type
No Intervention
Arm Description
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
Arm Title
Experimental - BFR
Arm Type
Experimental
Arm Description
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Intervention Type
Device
Intervention Name(s)
Blood flow restriction (BFR)
Intervention Description
The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
Primary Outcome Measure Information:
Title
Determine if BFR changes loss of LE lean muscle mass
Description
LE lean muscle mass was measured in grams using DEXA (iDXA, GE®)
Time Frame
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Title
Determine if BFR changes loss of bone mass
Description
Bone mass was measured in grams using DEXA (iDXA, GE®)
Time Frame
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Title
Determine if BFR changes loss of bone mineral density
Description
Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
Time Frame
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Secondary Outcome Measure Information:
Title
Does BFR change the number of exercise repetitions in functional physical therapy testing
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)
Time Frame
Week 8 and Week 12 post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick McCulloch, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16339340
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.
Results Reference
background
PubMed Identifier
20503732
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
19476179
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.
Results Reference
background
PubMed Identifier
26826014
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.
Results Reference
background
PubMed Identifier
21098818
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.
Results Reference
background
PubMed Identifier
28251287
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
17909396
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.
Results Reference
background
PubMed Identifier
26446893
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.
Results Reference
background
PubMed Identifier
22205678
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.
Results Reference
background
PubMed Identifier
20150565
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.
Results Reference
background
PubMed Identifier
28500081
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.
Results Reference
background
PubMed Identifier
21088601
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.
Results Reference
background
PubMed Identifier
29879638
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
25425002
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.
Results Reference
background
PubMed Identifier
25187395
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.
Results Reference
background
PubMed Identifier
26123943
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.
Results Reference
background
PubMed Identifier
28143359
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.
Results Reference
background
Citation
Rosenthal R. Parametric measures of effect size. The handbook of research synthesis. 1994;621:231-244.
Results Reference
background
PubMed Identifier
25430600
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.
Results Reference
background
PubMed Identifier
19653816
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.
Results Reference
background
PubMed Identifier
19065114
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.
Results Reference
background
PubMed Identifier
25264670
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.
Results Reference
background
PubMed Identifier
22303759
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.
Results Reference
background
PubMed Identifier
22105051
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.
Results Reference
background
PubMed Identifier
30197599
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.
Results Reference
background
Learn more about this trial
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
We'll reach out to this number within 24 hrs