Blood Flow Restriction Training for Lower Extremity Fractures

Overseen By Megan E Smith, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Denver Health and Hospital Authority

Disqualifiers: Osteoporosis, DVT, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a blood flow restriction device during light strength exercises can aid shinbone fracture healing more effectively than exercises without the device. The study aims to determine if this method can improve muscle strength, size, fracture healing, and help patients return to normal activities. Participants will be divided into two groups: one will use the blood flow restriction device, while the other will follow standard physical therapy. The trial seeks adults who have experienced a shinbone fracture and can begin physical therapy within two weeks after surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery methods for future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this blood flow restriction device is safe for use in patients with tibial shaft fractures?

Research has shown that blood flow restriction training (BFRT) is a safe method for recovery and injury prevention. Studies have found that it can increase muscle strength and size, even with lighter weights. In one study, participants reported significant improvements in pain and function after just four weeks of BFRT, surpassing results from traditional exercises alone.

The trial does not specify a phase, which might indicate an exploration of new applications for an existing method. This could suggest some level of safety, but it is crucial to consider personal health conditions before joining any trial. Consulting a healthcare provider ensures that this training is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about blood flow restriction training because it offers a fresh approach to rehabilitation for lower extremity fractures. Unlike traditional physical therapy, which involves standard exercises, this method uses a specialized device to restrict blood flow during exercises. This unique approach can stimulate muscle growth and strength with lower intensity workouts, potentially leading to faster recovery times. The possibility of enhancing muscle strength without the need for high-load exercises makes it a promising option for patients who are unable to perform intense physical activities due to their injury.

What evidence suggests that blood flow restriction training is effective for tibial shaft fractures?

This trial will compare Blood Flow Restriction Training (BFRT) with traditional physical therapy for patients with lower extremity fractures. Research has shown that BFRT can help build muscle strength. Specifically, studies have found that BFRT improves the strength of the quadriceps, the large muscle at the front of the thigh. This is particularly beneficial for individuals with weak knees or muscle loss. BFRT limits blood flow to the muscle during exercise, promoting muscle growth and strength even with lighter weights. Early results suggest it may aid recovery and reduce muscle loss after surgeries. Overall, BFRT could lead to faster recovery and better muscle growth for those with lower leg fractures. ^{2 3 5 6 7}

Who Is on the Research Team?

Megan E Smith, PT, DPT

Principal Investigator

Denver Health

Are You a Good Fit for This Trial?

This trial is for individuals with tibial shaft fractures. Participants should be able to perform low load strengthening exercises and must not have conditions that would interfere with exercise or use of a blood flow restriction device.

Inclusion Criteria

I have a closed fracture in my tibia.

I can start physical therapy within 2 weeks after surgery.

Exclusion Criteria

Pregnancy

Prisoner

My blood pressure is not higher than 180.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform physical therapy exercises with or without a blood flow restriction device

6 months

Regular visits as directed by a Doctor of Physical Therapy

Follow-up

Participants are monitored for muscle girth, strength, fracture healing, and physical function

6 months

Assessments at 2, 4, 6, 12 weeks and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Training

Trial Overview The study compares the effectiveness of using a blood flow restriction device during therapeutic exercises versus doing the exercises without it, focusing on muscle strength, size, fracture healing, and recovery time.

How Is the Trial Designed?

Group I: Blood flow restriction training Experimental Treatment 1 Intervention

Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device

Group II: Traditional physical therapy Active Control 1 Intervention

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.

Blood Flow Restriction Training is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Blood Flow Restriction Training for:

• Rehabilitation after patellar instability
• Post-operative rehabilitation
• Muscle strengthening in patients with injuries or physical limitations

Approved in European Union as Blood Flow Restriction Training for:

• Rehabilitation after orthopedic surgeries
• Muscle strengthening in elderly and arthritic patients
• Post-operative rehabilitation

Approved in Japan as KAATSU Training for:

• Muscle strengthening and hypertrophy
• Rehabilitation after injuries
• Improving muscle endurance

Who Is Running the Clinical Trial?

Denver Health and Hospital Authority

Lead Sponsor

Trials

106

Recruited

403,000+

Published Research Related to This Trial

Blood flow restriction training (BFRT) does not show significantly greater efficacy than conventional resistance training for treating knee osteoarthritis, based on a meta-analysis of 5 studies with low to moderate risk of bias.

BFRT may have a lower incidence of adverse events compared to high-load resistance training, suggesting it could be a safer option for patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Wang, HN., Chen, Y., Cheng, L., et al.[2022]

Blood flow restriction (BFR) training is considered a safe and effective method for improving musculoskeletal training outcomes, supported by 25 years of research.

There is a need for standardized, evidence-based protocols for BFR training among health professionals in South Africa to ensure its proper and safe application during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. Evans, RW., Ganda, J., van Schalkwyk, L., et al.[2023]

A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.

BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Low-load blood flow restriction (BFR) training, when combined with standard rehabilitation, showed significant improvements in muscle endurance and blood flow in patients undergoing anterior cruciate ligament reconstruction (ACLR), particularly noted in a preoperative study with a significant increase in muscle isometric endurance and blood flow to the vastus lateralis.

Postoperative BFR training demonstrated notable benefits in muscle hypertrophy and strength compared to traditional low-load resistance training, indicating that BFR could enhance recovery outcomes after ACLR, although more research is needed to confirm these findings due to the limited number of studies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Lu, Y., Patel, BH., Kym, C., et al.[2022]

In a study of 39 female patients with chronic ankle instability, Blood Flow Restriction (BFR) training alone did not improve muscle strength, dynamic balance, or physical function, while combined BFR with rehabilitation and rehabilitation alone showed significant improvements.

Both the BFR+R and R groups demonstrated enhanced muscle strength and dynamic balance, indicating that BFR is more effective when used alongside rehabilitation rather than as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of blood flow restriction as a stand-alone treatment on muscle strength, dynamic balance, and physical function in female patients with chronic ankle instability. Mahmoud, WS., Radwan, NL., Ibrahim, MM., et al.[2023]

Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.

The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]

A randomized controlled trial with 26 healthy participants showed that low-load blood flow restriction (BFR) training significantly increased muscle strength and limb circumference compared to a control group, with no reported adverse events.

BFR training was effective for strengthening muscle groups both proximal and distal to the tourniquet, and even improved strength in the non-restricted extremity, suggesting a systemic benefit from this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6299354/

Blood Flow–Restricted Training for Lower Extremity Muscle ... The limited published data show BFRT to be safe and potentially effective in improving quadriceps strength in patients with knee-related weakness and atrophy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07103252

Blood Flow Restriction Therapy to Optimize Muscle Size ... This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X24001652

Blood Flow Restriction Training: A Tool to Enhance ... BFRT facilitates gains in muscular strength and hypertrophy at lower loads, allowing for accelerated recovery and less disuse atrophy.

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08424-2

The effectiveness of individualized blood flow restriction ... The results showed that the individualized blood flow restriction training was feasible and suggested promising outcomes for participants after surgery.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1496482/full

The effect of blood flow restriction training on core muscle ... Results: Pain intensity and function disability level in LL-BFRT had extremely significant improvement at 4 weeks (p < 0.001, ES = 1.44–1.84).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8448465/

Blood Flow Restriction Training - PMC Evidence suggests that blood flow restriction training can improve function and pain outcomes beyond traditional resistance training in individuals with joint ...

7. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/122641-the-impact-of-blood-flow-restriction-training-on-tibial-bone-stress-injury-rehabilitation-an-exploratory-case-series

The Impact of Blood Flow Restriction Training on Tibial Bone ... The purpose of this study was to investigate the effects of lower extremity exercise with the addition of BFR upon bone mineral density, bone mineral content, ...