BFR Training for ACL Recovery

Recruiting at 1 trial location

Overseen By Andin Fosam, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Anticoagulants

Disqualifiers: Cardiovascular, Diabetes, Rheumatoid arthritis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a crossover phase 4 study to evaluate the impact of blood flow restriction on immunometabolism and gene expression in immune cells in individuals undergoing rehabilitation from anterior cruciate ligament reconstruction.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are using anticoagulant medications or have been treated with another investigational drug within one month of the study start.

What data supports the idea that BFR Training for ACL Recovery is an effective treatment?

The available research shows that BFR Training is effective for ACL recovery by helping to reduce muscle loss and improve knee strength. One study found that BFR Training helps increase quadriceps strength and size after ACL surgery. Another study highlights its benefits in reducing muscle weakness in adolescents after ACL reconstruction. Overall, BFR Training is shown to decrease muscle atrophy, which is a common issue after ACL surgery. ^{1 2 3 4 5}

What safety data exists for BFR training?

Numerous studies over the past 25 years have demonstrated the relative safety and efficacy of blood flow restriction (BFR) training. It is used in various settings, including rehabilitation after anterior cruciate ligament reconstruction, and is considered beneficial for those who cannot tolerate high-load exercises due to its lower stress on tissues and joints. ^{1 3 6 7 8}

Is the treatment AirBand promising for ACL recovery?

Yes, AirBand, which is a type of Blood Flow Restriction (BFR) Training, is promising for ACL recovery. It helps reduce muscle loss and improve knee strength after surgery, making it a valuable tool for rehabilitation. ^{1 2 3 4 6}

Research Team

Rachel Perry, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals aged 18-60 who are in good health and currently rehabilitating from anterior cruciate ligament reconstruction. Participants must be willing to follow the study procedures and have no recent smoking history, febrile illness, vascular issues in legs, or serious medical conditions like diabetes or rheumatoid arthritis.

Inclusion Criteria

Provision of signed and dated informed consent form

I am willing and able to follow the study rules and attend two visits a week apart.

I am between 18 and 60 years old.

Exclusion Criteria

I have had issues with blood flow in my legs, including clots.

I am currently taking blood thinners.

You are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two training sessions with blood flow restriction (BFR) and control interventions using AirBands

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for immunometabolic responses and gene expression changes after each training session

1-2 weeks

Treatment Details

Interventions

• AirBand

Trial Overview The study is testing the effects of blood flow restriction training using an AirBand device during rehabilitation after ACL surgery. It's a phase 4 crossover study focusing on how this method affects immune cell metabolism and gene expression.

Participant Groups

Group I: Uninflated Airbnd followed by AirBand Experimental Treatment 2 Interventions

The order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,

Group II: AirBand followed by uninflated AirBand Experimental Treatment 2 Interventions

The order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

In a study involving 32 adolescents (16 in the BFRT group and 16 in the control group), blood flow restriction training (BFRT) significantly improved isometric knee extension strength at both 3 months post-surgery and at the time of return to sport compared to traditional rehabilitation alone.

The BFRT group also reported better functional outcomes, as indicated by higher Pediatric International Knee Documentation Committee (Pedi-IKDC) scores, demonstrating enhanced patient-reported function after ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. Roman, DP., Burland, JP., Fredericks, A., et al.[2023]

Blood flow restriction (BFR) training combined with low-intensity resistance training (LIRT) shows promise in reducing quadriceps muscle atrophy after ACL reconstruction, with three out of four studies indicating an increase in muscle cross-sectional area.

The systematic review assessed four studies with moderate strength, suggesting that while BFR may be beneficial, further research is needed before it can be widely recommended in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION. Charles, D., White, R., Reyes, C., 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]

In a study of 30 participants who underwent ACL reconstruction, those using 80% arterial occlusion pressure (AOP) during blood flow restriction (BFR) training showed significant improvements in quadriceps strength and muscle thickness after 8 weeks compared to lower AOP levels and a control group.

The combination of BFR with low-intensity quadriceps training not only enhanced muscle recovery but also helped reduce strength deficits between the injured and healthy legs, suggesting that higher compression levels can optimize rehabilitation outcomes for ACLR patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of quadriceps training at different levels of blood flow restriction on quadriceps strength and thickness in the mid-term postoperative period after anterior cruciate ligament reconstruction: a randomized controlled external pilot study. Li, X., Li, J., Qing, L., et al.[2023]

Anterior cruciate ligament reconstruction (ACLR) is an effective surgical option for restoring knee stability and allowing athletes to return to sports more quickly after an ACL injury.

Blood flow restriction (BFR) is a promising rehabilitative technique that can be applied shortly after ACLR to enhance recovery, although further research is needed to fully understand its benefits in the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Current Concepts of Blood Flow Restriction in the Perioperative Period of Anterior Cruciate Ligament Reconstruction. Hasegawa, ME., Delos Reyes, CD., Rimm, JB., et al.[2023]

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]

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, when combined with traditional resistance training, can significantly enhance strength in healthy athletes, with 78% of studies showing notable improvements compared to control groups.

BFR training also has the potential to increase muscle size and improve sport-specific performance metrics, with 50% of studies reporting muscle size gains and 75% showing enhancements in athletic performance measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for Athletes: A Systematic Review. Wortman, RJ., Brown, SM., Savage-Elliott, I., et al.[2021]

References

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

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. [2023]

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

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Effect of quadriceps training at different levels of blood flow restriction on quadriceps strength and thickness in the mid-term postoperative period after anterior cruciate ligament reconstruction: a randomized controlled external pilot study. [2023]

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

Update on Current Concepts of Blood Flow Restriction in the Perioperative Period of Anterior Cruciate Ligament Reconstruction. [2023]

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. 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]

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

Blood Flow Restriction Training for Athletes: A Systematic Review. [2021]