Tibial FracturesNCT06496035
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
A study testing Blood Flow Restriction with low load exercise and Therapeutic Exercise in people with Tibial Fractures and Lower Extremity Fracture, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Fractures, Lower Extremity Fracture
- What is being tested?
- Blood Flow Restriction with low load exercise and Therapeutic Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult with closed tibial shaft fracture
- Ability to begin physical therapy treatment within 2 weeks post-operatively
Who cannot join
- 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
Show all 12Show fewer
- Renal compromise
- Severe uncontrolled hypertension (SBP>180)
- Lymphedema
- Under age 18
- Pregnancy
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Megan E Smith, PT, DPT, 651-319-1730, megan.smith@dhha.org
Mathew A Haager, PT, DPT, 5639407061, mat.haager@dhha.org
About this study
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
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.
Read the 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.
- Conditions
- Tibial Fractures, Lower Extremity Fracture
- Being tested
- Blood Flow Restriction with low load exercise, Therapeutic Exercise
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction with low load exerciseDevice
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 ExerciseOther
Exercise performed at appropriate load as guided by physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training | Experimental | Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device Receives: Device: Blood Flow Restriction with low load exercise |
| Traditional physical therapy | Active comparator | 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. Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing
Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures
Measured: 6 weeks, 12 weeks, 6 months
Secondary outcomes (3)
Muscle strength
Knee extension and ankle plantarflexion strength measured with a dynamometer
Measured: 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
Measured: 2, 4, 6, 12 weeks and 6 months
Physical function
Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)
Measured: 2, 6,12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Nov 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan E Smith, PT, DPT, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496035
- Sponsor's protocol ID
- 24-0894
- Status last verified
- Oct 2025
- First submitted
- 3 Jul 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06496035
- Acronym / sponsor ID
- 24-0894
- Conditions
- Tibial Fractures, Lower Extremity Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training | Experimental | Device: Blood Flow Restriction with low load exercisePatients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device |
| Traditional physical therapy | Active comparator | Other: Therapeutic ExercisePatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult with closed tibial shaft fracture
- Ability to begin physical therapy treatment within 2 weeks post-operatively
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction with low load exerciseCuff/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. | Device | Blood flow restriction training |
| Therapeutic ExerciseExercise performed at appropriate load as guided by physical therapist | Other | Traditional physical therapy |
Primary outcome
Fracture healing
Time frame: 6 weeks, 12 weeks, 6 months
Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan E Smith, PT, DPT principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction with low load exercise and Therapeutic Exercise in people with Tibial Fractures and Lower Extremity Fracture, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan E Smith, PT, DPT (6513191730, megan.smith@dhha.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing (time frame: 6 weeks, 12 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.