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OpenTrials
Completed

NCT Number: NCT04302558

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

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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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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