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CompletedNCT04302558Updated Feb 3, 2023

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

An interventional study of Exercise Blood Flow Restriction training and SHAM Exercise Blood Flow Restriction training in ACL Injury, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 13 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
13 Years to 40 Years
Sex
All
01

Study 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.

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Conditions studied

  • ACL Injury
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In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's enrollment of 29 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
29 participants (actual)

Study arms

  • 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.

    Behavioral: Exercise Blood Flow Restriction training

  • 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

    Behavioral: SHAM Exercise Blood Flow Restriction training

Interventions

  • BehavioralExercise Blood Flow Restriction training

    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

  • BehavioralSHAM Exercise Blood Flow Restriction training

    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

06

What researchers measure

Primary outcomes

  1. Change in muscle diameter (hypertrophy)

    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 outcomes

  1. 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

    Time frame: 2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative

07

Study locations

1 site
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04302558
Lead sponsor
Mayo Clinic
Responsible party
Anikar Chhabra (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 10, 2020
Start date
Dec 18, 2020
Primary completion
May 4, 2022
Completion
May 4, 2022
Last update
Feb 3, 2023

Study contacts

Anikar Chhabra, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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