An interventional study of Blood Flow Restriction with low load exercise and Therapeutic Exercise in Tibial Fractures and Lower Extremity Fracture, sponsored by Denver Health and Hospital Authority. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Treatment
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.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
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Exclusion Criteria:
Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device
Device: Blood Flow Restriction with low load exercise
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.
Other: Therapeutic 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.
Exercise performed at appropriate load as guided by physical therapist
Fracture 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
Plan to share: No
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Denver Health and Hospital Authority