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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Blood Flow Restriction Training for lower extremity fractures?

Research shows that Blood Flow Restriction Training (BFR) can help improve muscle strength and function with less stress on tissues and joints, making it useful for people who can't handle heavy exercises. It's been effective in rehabilitation after surgeries and for conditions like knee osteoarthritis, suggesting it could also be beneficial for lower extremity fractures. ^{1 2 3 4 5}

How is Blood Flow Restriction Training different from other treatments for lower extremity fractures?

Blood Flow Restriction Training (BFR) is unique because it allows patients to perform low-weight exercises while using a cuff to restrict blood flow, which can help build muscle strength and size without the need for heavy weights. This is particularly beneficial for patients who cannot tolerate high-load exercises, as it reduces stress on tissues and joints compared to traditional rehabilitation methods. ^{2 3 4 6 7}

Research Team

Megan E Smith, PT, DPT

Principal Investigator

Denver Health

Eligibility Criteria

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 can start physical therapy within 2 weeks after surgery.

I have a closed fracture in my tibia.

Exclusion Criteria

My kidney function is not normal.

Pregnancy

My blood pressure is not higher than 180.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]

6. United States 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. [2023]

7. South Africa pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. [2023]