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

Primary Purpose

ACL Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Blood Flow Restriction training

SHAM Exercise Blood Flow Restriction training

About this trial

This is an interventional supportive care trial for ACL Injury

Eligibility Criteria

13 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Blood Flow Restriction (BFR) group

SHAM Blood Flow Restriction (BFR) group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in muscle diameter (hypertrophy)

Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04302558

First Posted

March 8, 2020

Last Updated

February 1, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04302558

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

December 18, 2020 (Actual)

Primary Completion Date

May 4, 2022 (Actual)

Study Completion Date

May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ACL Injury

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blood Flow Restriction (BFR) group

Arm Type

Experimental

Arm Description

Arm Title

SHAM Blood Flow Restriction (BFR) group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise Blood Flow Restriction training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

SHAM Exercise Blood Flow Restriction training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in muscle diameter (hypertrophy)

Description

Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris

Time Frame

2 weeks pre-operative, 8-10 days post-operative

Secondary Outcome Measure Information:

Title

Change in muscle strength

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anikar Chhabra, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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