Actively Recruiting
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
Led by Denver Health and Hospital Authority · Updated on 2025-11-21
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of using a blood flow restriction (BFR) device during low load strengthening exercises on patients with tibial shaft fractures. The study compares outcomes between patients who use the BFR device and those who perform exercises without it. The goal is to assess muscle strength, muscle size, fracture healing, and the return to normal function in these patients. Participants will be randomly assigned to one of two groups. The BFR group will perform strengthening exercises with a device that partially restricts venous blood flow in the leg using a cuff inflated to 60-80% of limb occlusion pressure, guided by a Doctor of Physical Therapy. The control group will perform the same exercises without the blood flow restriction device, following standard physical therapy practice. During the study, researchers will monitor fracture healing at 6 weeks, 12 weeks, and 6 months. Muscle strength, muscle girth, and physical function will be evaluated at multiple time points including 2, 4, 6, 12 weeks, and 6 months. Participants will follow a defined exercise protocol, and outcomes related to bone metabolism and tissue healing will be assessed. The total participation duration spans up to 6 months to observe recovery and rehabilitation progress.
CONDITIONS
Brief Title
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult with closed tibial shaft fracture
- Ability to begin physical therapy treatment within 2 weeks post-operatively
- Age between 18 and 100 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants perform physical therapy exercises with or without a blood flow restriction device as directed by a Doctor of Physical Therapy to aid fracture healing and muscle recovery.
Multiple visits over 6 months for physical therapy and assessments
Trial Site Locations
Total: 1 location
1
Denver Health Medical Center
Denver, Colorado, United States, 80204
Actively Recruiting
Research Team
M
Megan E Smith, PT, DPT
M
Mathew A Haager, PT, DPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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