Lower Extremity Fracture, Tibial Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBlood Flow Restriction with low load exercise
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.
OTHERTherapeutic Exercise
Exercise performed at appropriate load as guided by physical therapist
Sponsors
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart.
Intervention model description
Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult with closed tibial shaft fracture * Ability to begin physical therapy treatment within 2 weeks post-operatively
Exclusion criteria
* History of osteoporosis or osteopenia * Impaired circulation in the limb * Active deep vein thrombosis * Clotting disorders or other elevated risk of embolism * Sickle cell anemia * Infection in extremity * Renal compromise * Severe uncontrolled hypertension (SBP\>180) * Lymphedema * Under age 18 * Pregnancy * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture healing | 6 weeks, 12 weeks, 6 months | Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months | Knee extension and ankle plantarflexion strength measured with a dynamometer |
| Muscle girth | 2, 4, 6, 12 weeks and 6 months | Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line |
| Physical function | 2, 6,12 weeks and 6 months | Subjective measure of function measured by Lower Extremity Functional Scale (LEFS) |
Countries
United States
Contacts
Primary ContactMegan E Smith, PT, DPT
Backup ContactMathew A Haager, PT, DPT
Outcome results
None listed