Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Denver Health and Hospital Authority

Status: Enrolling

Conditions: Tibial Fractures; Lower Extremity Fracture

Treatments: Other: Therapeutic Exercise; Device: Blood Flow Restriction with low load exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06496035

24-0894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Blood flow restriction training

Experimental group

Description:

Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device

Treatment:

Device: Blood Flow Restriction with low load exercise

Traditional physical therapy

Active Comparator group

Description:

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.

Treatment:

Other: Therapeutic Exercise