Clinical trial NCT06496035: Blood Flow Restriction Training in Patients With Lower Extremity Fractures
Official title: Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures: Effect on Fracture Healing, Muscle Strength and Girth, and Return to Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tibial Fractures
Lower Extremity Fracture
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fracture healing
timeFrame: 6 weeks, 12 weeks, 6 months
Secondary outcomes:
measure: Muscle strength
timeFrame: 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months
measure: Muscle girth
timeFrame: 2, 4, 6, 12 weeks and 6 months
measure: Physical function
timeFrame: 2, 6,12 weeks and 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Megan E Smith, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: