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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
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
March 8, 2020
Last Updated
February 1, 2023
Sponsor
Mayo Clinic
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
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
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
No
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
No
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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