ACL Injury
Conditions
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.
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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 40 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle diameter (hypertrophy) | 2 weeks pre-operative, 8-10 days post-operative | Measured using ultrasound images of the musculature and soft tissue of the quadriceps femoris |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength | 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 |
Countries
United States
Outcome results
None listed