Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction

Researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.

Study Overview

• Status: Completed
• Conditions: ACL Injury
• Intervention / Treatment: Device: Blood Flow Restriction (BFR)Cuff; Device: SHAM Blood Flow Restriction (BFR) cuff

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be between 13 and 40 years old
• Subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction
• Subjects must be able to understand study procedures and comply with them for the entire duration of the study
• Subjects must have normal contralateral limb strength

Exclusion Criteria:

• Subjects with any personal history of deep vein thrombosis or with such history in their immediate family
• Subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading
• Subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg
• Subjects with an inability or unwillingness of individual or legal guardian to give written informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Flow Restriction (BFR) group; Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while the blood flow to the leg is reduced by a blood flow restriction cuff.	Device: Blood Flow Restriction (BFR)Cuff; Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow
Sham Comparator: SHAM Blood Flow Restriction (BFR) group; Subjects previously diagnosed with a torn ACL who have yet to undergo surgical reconstruction and pre-operative rehabilitation will do a series of low-intensity strength exercises while a blood flow restriction cuff is applied but inflation pressure will be limited	Device: SHAM Blood Flow Restriction (BFR) cuff; Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle diameter (hypertrophy)	Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris	2 weeks pre-operative, 8-10 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle strength	Muscle strength will be measured in subjects as the percent strength of the injured leg compared to the non-injured leg based on handheld dynamometer and the number of leg presses performed at the 1-rep maximum	2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anikar Chhabra, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 8, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

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: 19-008473

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: Yes