Clinical trial NCT03758755: Blood Flow Restriction Following ACL Reconstruction
Official title: The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: BFR
ACL
rehabilitation
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 49
Sex: ALL
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.

Detailed description: Recovery from anterior cruciate ligament (ACL) reconstruction involves early physical therapy to promote muscular development. Traditional training regimens are based on the concept that muscle growth is induced with high resistance exercises of at least 65-70% of 1-repetition maximum. Achieving a high resistance level can be challenging in the early post-surgical patient who may be limited by pain, muscle atrophy, diminished proprioception, and psychological factors. Increasing evidence has suggested that Blood Flow Restriction (BFR) in resistance training, while transmitting a decreased load (25-50% of 1-repetition maximum) across the surgical site, may provide an additional benefit of inducing muscular development similar to that of high intensity exercises .

Augmenting exercises with BFR involves an external pressure cuff applied to the proximal portion of the extremity, which is inflated to a pressure that restricts venous outflow while allowing arterial inflow to continue. This creates a physiologic environment for the patient to gain the hypertrophic effect of high resistance training, though at a lower and safer intensity. Studies suggest that BFR stimulates muscular development through an increase in metabolic stress, muscle fiber recruitment, cell swelling, and protein synthesis.

Eligibility criteria: Inclusion Criteria:

1. Age 13-35 years at the time of surgery
2. Anterior Cruciate Ligament (ACL) reconstruction
3. Using a physical therapy center with Blood Flow Restriction capabilities.

Exclusion Criteria:

1. Concomitant ligament reconstruction
2. Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
3. History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
4. Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
5. History of coagulation disorders or current use of anticoagulants
6. Completion of physical therapy at a location not affiliated with the study
7. Pregnancy

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Questionnaire Score
timeFrame: Measured preoperatively and at 12 weeks post-op.
measure: Visual Analog Score
timeFrame: Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
measure: Quadriceps Tendon Strength
timeFrame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
measure: Thigh Circumference
timeFrame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
measure: Degrees of Knee Flexion
timeFrame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
measure: Degrees of Knee Extension
timeFrame: Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Secondary outcomes:
measure: Adverse Effects
timeFrame: Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Orthopedic Surgeon
name: Edward Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
citation: Iversen E, Rostad V, Larmo A. Intermittent blood flow restriction does not reduce atrophy following anterior cruciate ligament reconstruction. J Sport Health Sci. 2016 Mar;5(1):115-118. doi: 10.1016/j.jshs.2014.12.005. Epub 2015 Apr 18.
citation: Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
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citation: Takada S, Okita K, Suga T, Omokawa M, Morita N, Horiuchi M, Kadoguchi T, Takahashi M, Hirabayashi K, Yokota T, Kinugawa S, Tsutsui H. Blood flow restriction exercise in sprinters and endurance runners. Med Sci Sports Exerc. 2012 Mar;44(3):413-9. doi: 10.1249/MSS.0b013e31822f39b3.
citation: Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
citation: Yasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.