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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302558
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Anikar Chhabra, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
ACL Injury Device: Blood Flow Restriction (BFR)Cuff Device: SHAM Blood Flow Restriction (BFR) cuff Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Low-Intensity Blood Flow Restriction Training as a Pre-Operative Rehabilitative Modality to Improve Post-Operative Outcomes for ACL Reconstruction
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in muscle diameter (hypertrophy) [ Time Frame: 2 weeks pre-operative, 8-10 days post-operative ]
    Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris


Secondary Outcome Measures :
  1. Change in muscle strength [ Time Frame: 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative ]
    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



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Ages Eligible for Study:   13 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302558


Contacts
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Contact: Jedediah (Jed) Lee, PT, DPT (480) 342-6807 Lee.Jedediah@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Anikar Chhabra, MD Mayo Clinic

Additional Information:
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Responsible Party: Anikar Chhabra, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04302558    
Other Study ID Numbers: 19-008473
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries