Blood flow restriction–enhanced rehabilitation for people with tibial shaft 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
Run by Denver Health and Hospital Authority · NCT06496035 · Data updated 2026-11-12
This trial will test whether using a blood flow restriction device during low-load strengthening exercises helps adults with tibial shaft fractures regain muscle strength and size, heal their fracture, and return to normal function faster than standard exercises alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Denver Health and Hospital Authority Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06496035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with closed tibial shaft fractures who can begin physical therapy within two weeks after surgery and who do not have exclusionary vascular, clotting, bone density, renal, or pregnancy-related conditions are appropriate candidates.
✕Probably not a fit
Patients with impaired limb circulation, active deep vein thrombosis, clotting disorders, sickle cell disease, osteoporosis or osteopenia, lymphedema, severe uncontrolled hypertension, significant renal compromise, infection in the limb, pregnancy, age under 18, or incarceration are excluded and would not be candidates for this BFR protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional study will assign adults with closed tibial shaft fractures to either a blood flow restriction (BFR) group or a control group that performs the same low-load strengthening exercises without BFR. The BFR group will use a device that partially occludes venous flow in the limb while performing supervised exercises with a Doctor of Physical Therapy, and the control group will receive standard therapeutic exercise. Outcomes include objective measures of muscle strength and girth, radiographic or clinical measures of fracture healing, and patient-reported physical function over the rehabilitation period. The protocol excludes patients with conditions that increase vascular or thrombotic risk and requires initiation of physical therapy within two weeks post-operatively at the study site.
Why it matters
Potential benefit: If successful, adding BFR to low-load exercise could preserve or improve muscle and may speed functional recovery and fracture healing after tibial shaft fractures.
How similar studies have gone: Smaller postoperative and injury-focused studies have shown that BFR can limit muscle atrophy and improve strength and have suggested favorable changes in bone metabolism markers, but its specific application in tibial fracture trauma patients is less well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Denver Health Medical Center
Denver, Colorado, United States Recruiting
Study contacts
- Principal investigator: Megan E Smith, PT, DPT — Denver Health
- Study coordinator: Megan E Smith, PT, DPT
- Email: megan.smith@dhha.org
- Phone: 6513191730
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.