This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.
This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.
Exercise performed at appropriate load as guided by physical therapist
Denver Health Medical Center
Denver, Colorado, United States
RECRUITINGFracture healing
Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures
Time frame: 6 weeks, 12 weeks, 6 months
Muscle strength
Knee extension and ankle plantarflexion strength measured with a dynamometer
Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months
Muscle girth
Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line
Time frame: 2, 4, 6, 12 weeks and 6 months
Physical function
Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)
Time frame: 2, 6,12 weeks and 6 months
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