Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

October 10, 2024 updated by: Patrick McCulloch,MD, The Methodist Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control - Routine Rehab
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
Experimental: Experimental - BFR
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if BFR Changes Loss of LE Lean Muscle Mass
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®)
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Determine if BFR Changes Loss of Bone Mass
Time Frame: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Bone mass was measured in grams using DEXA (iDXA, GE®)
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Determine if BFR Changes Loss of Bone Mineral Density
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®)
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: Week 8 and Week 12 post-surgery
Single leg (SL) squat (best of 3 attempts)
Week 8 and Week 12 post-surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
SL eccentric step down (reps to fatigue or inadequate technique)
8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance anterior (best of 3 attempts)
8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance posteromedial (best of 3 attempts)
8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
Y-balance posterolateral (best of 3 attempts)
8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
SL leg press (1RM)
8 weeks post surgery, 12 weeks post surgery
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Time Frame: 8 weeks post surgery, 12 weeks post surgery
SL hamstring curl (1RM)
8 weeks post surgery, 12 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Patrick McCulloch, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2016

Primary Completion (Actual)

July 10, 2020

Study Completion (Actual)

July 10, 2020

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro000138201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ACL Tear

Clinical Trials on Blood flow restriction (BFR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe