Blood Flow Restriction Training in ACL Surgery

Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction

This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects

Study Overview

• Status: Terminated
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: blood flow restriction; Other: physical therapy standard of care

Detailed Description

This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.

Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.

Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • UAMS Center on Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women, ages 18-34 years.
2. Scheduled to undergo elective ACL surgery at UAMS.
3. Capable of providing informed consent.
4. Willing to exercise with BFR.
5. COVID-19 negative or asymptomatic.

Exclusion Criteria:

1. Any surgical indication other than ACL repair.
2. Body mass index >40.
3. Pregnant female.
4. Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
5. Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.
6. Heart failure as evidenced by use of prescription diuretics.
7. History of atrial fibrillation.
8. Oxygen saturation <95% on room air at rest.
9. Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
11. Compromised vascular circulation in the legs (e.g. peripheral vascular disease).
12. History of deep vein thrombosis.
13. Varicose veins in the legs.
14. Known Sickle cell disease or trait.
15. Unwilling to avoid using protein or amino-acid supplements during participation.
16. Unwilling to avoid using BFR during prescribed post-operative physical therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: physical therapy with blood flow restriction	Other: blood flow restriction; Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
Other: physical therapy without blood flow restriction; Standard of care.	Other: physical therapy standard of care; the current standard of care after surgery for ACL repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Voluntary Contraction	Max torque produced in newton meter per second during an isometric contraction	16-weeks post-surgery
ACL Repair Range of Motion	Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.	from enrollment to the end of treatment at 16 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Arny A Ferrando, Ph.D., University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 261865

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