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

NCT04302558 | Completed

• 1 other identifier: 19-008473
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in muscle strength

  2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative

Study Arms (2)

Blood Flow Restriction (BFR) group

EXPERIMENTAL

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.

Behavioral: Exercise Blood Flow Restriction training

SHAM Blood Flow Restriction (BFR) group

SHAM COMPARATOR

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

Behavioral: SHAM Exercise Blood Flow Restriction training

Interventions

Exercise Blood Flow Restriction training BEHAVIORAL

While exercising, an Inflatable cuff, similar to a blood pressure cuff, is applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow

Blood Flow Restriction (BFR) group

SHAM Exercise Blood Flow Restriction training BEHAVIORAL

While exercising 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

SHAM Blood Flow Restriction (BFR) group

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• McGurren DP, Glattke KE, Chhabra A, Boddu SP, Poon SK, Flug JA, Brinkman JC, Goetzinger S, Lee JE, Nocella A, Rogge J, De Luigi AJ. Assessment of Interrater Reliability for Interpretation of Musculoskeletal Ultrasound Imaging of the Quadriceps Femoris. Am J Phys Med Rehabil. 2025 Oct 1;104(10):906-910. doi: 10.1097/PHM.0000000000002731. Epub 2025 Mar 6.

  PMID: 40101801 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Anikar Chhabra, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 10, 2020
• Study Start: December 18, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)