Blood Flow Restriction Training in Patients With Lower Extremity Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Flow Restriction with low load exercise, Therapeutic Exercise.
- Who it may be relevant to
- Registry conditions: Tibial Fractures, Lower Extremity Fracture. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device Blood 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. - Other Therapeutic Exercise
Exercise performed at appropriate load as guided by physical therapist
Primary outcome measures
- Fracture healing [Time frame: 6 weeks, 12 weeks, 6 months]
Secondary outcome measures (3)
- Muscle strength [Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months]
- Muscle girth [Time frame: 2, 4, 6, 12 weeks and 6 months]
- Physical function [Time frame: 2, 6,12 weeks and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Denver Health Medical Center — Denver
Identifiers
NCT: NCT06496035 · 24-0894