Blood Flow Restriction Training in Patients With Lower Extremity Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tibial Fractures; Lower Extremity Fracture
• Intervention / Treatment: Device: Blood Flow Restriction with low load exercise; Other: Therapeutic Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan E Smith, PT, DPT; Phone Number: 6513191730; Email: megan.smith@dhha.org
• Study Contact Backup: Name: Mathew A Haager, PT, DPT; Phone Number: 5639407061; Email: mat.haager@dhha.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health Medical Center
      • Contact: Mathew A Haager, PT, DPT; Phone Number: 5639407061; Email: mat.haager@dhha.org
      • Contact: Megan E Smith, PT, DPT; Phone Number: 651-319-1730; Email: megan.smith@dhha.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction training; 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; 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.
Active Comparator: Traditional physical therapy; 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; Exercise performed at appropriate load as guided by physical therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Megan E Smith, PT, DPT, Denver Health

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: 24-0894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No