Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?

The University of Texas System (UT)

Status: Enrolling

Conditions: Quadriceps Atrophy; ACL Reconstruction

Treatments: Device: Blood flow restriction; Other: Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03096366

HSC-MS-16-1047

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.

Enrollment: 150 estimated patients

Sex: All

Ages: 14 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anterior cruciate ligament (ACL) reconstruction with concomitant meniscus or cartilage restoration procedures
• Adherence to modified weight bearing status before initiation of PT
• Expected participation in recreational or competitive sports after release to full activities

Exclusion criteria

• Unable to attend (or participate in) physical therapy
• Pregnancy
• Malignancy
• Fracture
• Peripheral vascular disease
• History of deep vein thrombosis (DVT)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Physical therapy (PT) plus blood flow restriction (BFR)

Experimental group

Description:

Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg).

Treatment:

Device: Blood flow restriction

Other: Physical therapy

Physical therapy

Active Comparator group

Description:

Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.

Treatment:

Other: Physical therapy