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Blood Flow Restriction Following ACL Reconstruction (BFR)

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Therapy
ACL Reconstruction rehabilitation
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring BFR, ACL, rehabilitation

Eligibility Criteria

13 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inova Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BFR Therapy

No BFR

Arm Description

This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.

This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR

Outcomes

Primary Outcome Measures

International Knee Documentation Committee (IKDC) Questionnaire Score
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Visual Analog Score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Quadriceps Tendon Strength
We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Thigh Circumference
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Degrees of Knee Flexion
Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Degrees of Knee Extension
Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.

Secondary Outcome Measures

Adverse Effects
Observation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.

Full Information

First Posted
November 14, 2018
Last Updated
November 30, 2022
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT03758755
Brief Title
Blood Flow Restriction Following ACL Reconstruction
Acronym
BFR
Official Title
The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inova Health Care Services

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
BFR, ACL, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFR Therapy
Arm Type
Experimental
Arm Description
This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.
Arm Title
No BFR
Arm Type
Active Comparator
Arm Description
This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction Therapy
Intervention Description
A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
Intervention Type
Other
Intervention Name(s)
ACL Reconstruction rehabilitation
Intervention Description
post-operative rehabilitation according to current standards of care
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) Questionnaire Score
Description
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Time Frame
Measured preoperatively and at 12 weeks post-op.
Title
Visual Analog Score
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain," with "no pain" corresponding to a VAS score of 0 and "worst pain" corresponding to a VAS score of 10.
Time Frame
Measured preoperatively, at 2-weeks post-op, 6 weeks post-op, and 12 weeks post-op
Title
Quadriceps Tendon Strength
Description
We will measure quadriceps tendon strength (closed chain) strength using a hand-held dynamometer placed just distal to the knee joint on the posterior calf with the patient in the supine position. The outcome will be reported biweekly as a percentage of the strength of the contralateral side, and then finally reported as a change in strength from the first measurement to the final measurement. The results reported in this data table refer to the percent strength of the operated leg when compared to the contralateral side. The change in strength results can be found in the statistical analysis section.
Time Frame
Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Title
Thigh Circumference
Description
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella. The outcome will be reported biweekly as a percentage of the contralateral side, and then finally reported as a change in circumference from the first measurement to the final measurement. The results reported in this data table refer to the percent circumference of the operated leg when compared to the contralateral side. The change in circumference results can be found in the statistical analysis section.
Time Frame
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Title
Degrees of Knee Flexion
Description
Degrees of knee flexion will be measured on the operative side by a licensed physical therapist. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee flexion at each reported time point. The change in knee flexion results can be found in the statistical analysis section.
Time Frame
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Title
Degrees of Knee Extension
Description
Degrees of knee extension will be measured on the operative side by a licensed physical therapist, with zero degrees indicating the knee completely at extension and negative degrees indicating degrees of hyperextension. The outcome will be reported biweekly and then finally reported as a change in degrees from the first measurement to the final measurement. The results reported in this data table refer to the degrees of knee extension at each reported time point. The change in knee extension results can be found in the statistical analysis section.
Time Frame
Tracked in the perioperative week and then from initiation of therapy 2 weeks post-op through 12 weeks post-op.
Secondary Outcome Measure Information:
Title
Adverse Effects
Description
Observation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.
Time Frame
Tracked from initiation of therapy 2 weeks post-op through 12 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 13-35 years at the time of surgery Anterior Cruciate Ligament (ACL) reconstruction Using a physical therapy center with Blood Flow Restriction capabilities. Exclusion Criteria: Concomitant ligament reconstruction Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc) History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE) Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.) History of coagulation disorders or current use of anticoagulants Completion of physical therapy at a location not affiliated with the study Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Chang, MD
Organizational Affiliation
Orthopedic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Health System
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28259850
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.
Results Reference
background
PubMed Identifier
30356481
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.
Results Reference
background
PubMed Identifier
12635796
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.
Results Reference
background
PubMed Identifier
26118847
Citation
Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Blood flow restricted exercise for athletes: A review of available evidence. J Sci Med Sport. 2016 May;19(5):360-7. doi: 10.1016/j.jsams.2015.04.014. Epub 2015 May 9.
Results Reference
background
PubMed Identifier
22415101
Citation
Suga T, Okita K, Takada S, Omokawa M, Kadoguchi T, Yokota T, Hirabayashi K, Takahashi M, Morita N, Horiuchi M, Kinugawa S, Tsutsui H. Effect of multiple set on intramuscular metabolic stress during low-intensity resistance exercise with blood flow restriction. Eur J Appl Physiol. 2012 Nov;112(11):3915-20. doi: 10.1007/s00421-012-2377-x. Epub 2012 Mar 14.
Results Reference
background
PubMed Identifier
21795999
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.
Results Reference
background
PubMed Identifier
10846023
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.
Results Reference
background
PubMed Identifier
19253083
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.
Results Reference
background

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Blood Flow Restriction Following ACL Reconstruction

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