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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood flow restriction training | Experimental | Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device |
|
| Traditional physical therapy | Active Comparator | Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction with low load exercise | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture healing | Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures | 6 weeks, 12 weeks, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Knee extension and ankle plantarflexion strength measured with a dynamometer | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan E Smith, PT, DPT | Contact | 6513191730 | megan.smith@dhha.org | |
| Mathew A Haager, PT, DPT | Contact | 5639407061 | mat.haager@dhha.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan E Smith, PT, DPT | Denver Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Recruiting | Denver | Colorado | 80204 | United States |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device
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Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart.
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| Therapeutic Exercise | Other | Exercise performed at appropriate load as guided by physical therapist |
|
| 2, 4, 6, 12 weeks and 6 months |
| Physical function | Subjective measure of function measured by Lower Extremity Functional Scale (LEFS) | 2, 6,12 weeks and 6 months |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |