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NCT Number: NCT06496035

Blood Flow Restriction Training in Patients With Lower Extremity Fractures

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction with low load exercise

Device

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.

Therapeutic exercise

Other

Exercise performed at appropriate load as guided by physical therapist

Primary outcomes

  1. Fracture healing

    Time frame: 6 weeks, 12 weeks, 6 months

    Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures

Secondary outcomes

  1. Muscle strength

    Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months

    Knee extension and ankle plantarflexion strength measured with a dynamometer

  2. Muscle girth

    Time frame: 2, 4, 6, 12 weeks and 6 months

    Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line

  3. Physical function

    Time frame: 2, 6,12 weeks and 6 months

    Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)

Study contacts

Contact information is provided by the study sponsor or research team.

Mathew A Haager, PT, DPT

CONTACT

[email protected]

5639407061

Megan E Smith, PT, DPT

CONTACT

[email protected]

6513191730

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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