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

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302558
• Other study ID #: 19-008473
• Status: Completed
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: May 4, 2022

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Behavioral:
• Exercise 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
• SHAM 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle diameter (hypertrophy)	Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris	2 weeks pre-operative, 8-10 days post-operative
Secondary	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	2 weeks pre-operative, 4 weeks pre-operative, 8 weeks post-operative

External Links

•   Mayo Clinic Clinical Trials