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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special device called AirBand might aid recovery from ACL (a knee ligament) surgery. The researchers aim to determine if restricting blood flow during rehab exercises can alter immune cell activities and gene expression, potentially speeding up recovery. Participants will use both inflated and uninflated versions of the AirBand to compare effects. The trial suits individuals who have undergone ACL surgery, are in generally good health, and can attend two study sessions at least one week apart. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve recovery methods for ACL surgery patients.

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 is the safety track record for AirBand?

Research has shown that blood flow restriction (BFR) therapy, such as that used with AirBand, is generally easy to handle. Studies have found that BFR can help maintain muscle strength and aid recovery after surgeries like ACL reconstruction. Although long-term safety data on BFR is limited, current research suggests it is safe when used properly. Some individuals might experience mild discomfort during use, but serious side effects are rare. Overall, AirBand and similar devices are considered safe for short-term use in rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BFR (Blood Flow Restriction) Training for ACL recovery because it offers a unique approach compared to traditional rehabilitation methods. Unlike standard exercises that rely on heavy weights to rebuild muscle strength after an ACL injury, BFR uses an inflatable device such as the AirBand to restrict blood flow, allowing muscles to grow stronger using lighter weights. This method can reduce stress on the healing joint, potentially speeding up recovery and reducing the risk of re-injury. Additionally, the AirBand's ability to be used both inflated and uninflated provides flexibility in treatment, making it adaptable for different stages of recovery.

What evidence suggests that AirBand BFR Training is effective for ACL recovery?

Research has shown that blood flow restriction (BFR) therapy, such as the AirBand, holds promise for ACL recovery. In this trial, participants will undergo both inflated and uninflated AirBand sessions. Studies indicate that BFR helps maintain muscle strength and size during rehabilitation without heavy weights, which is especially beneficial post-surgery. One review found that BFR can reduce muscle loss in the thigh after ACL surgery and may lead to better recovery outcomes than traditional exercises alone. Overall, evidence supports BFR as an effective method to aid recovery after ACL reconstruction. ^{5 6 7 8 9}

Who Is on the Research Team?

Rachel Perry, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 in good health with no conditions that would risk my safety in the study.

Exclusion Criteria

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

I am currently taking blood thinners.

You are pregnant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. airbandsbfr.com airbandsbfr.com/products/bfr-bands?srsltid=AfmBOooLaeY8EwYkS-KE12-6m1gvn4Fhn4lyYN3u-Nzk5Bb9SzvoH_yL

AirBands 2.0 Blood Flow Restriction Therapy Preserves Whole Limb Bone and Muscle Following ACL Reconstruction. Store Service. Increased strength (rehab). Restoring knee ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7727417/

A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD ... This review of the available evidence yields promising results regarding the use of BFR and LIRT in the remediation of femoral muscle atrophy after an ACL ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X2100016X

Rehabilitation outcomes and parameters of blood flow ... Rehabilitation with blood flow restriction (BFR) produces gains in strength and muscle mass, avoiding the use of heavy loads.

4. mdpi.com mdpi.com/2077-0383/13/20/6265

Blood Flow Restriction Training and Its Use in ... Conclusions: BFRT shows promise for maintaining muscle mass and improving patient reported outcomes following ACL reconstruction. However, the high risk of bias ...

5. researchgate.net researchgate.net/publication/377583992_Effectiveness_of_Blood_Flow_Restriction_Training_on_Increasing_Strength_in_Post_Surgery_Rehabilitation_of_Anterior_Cruciate_Ligament_ACL_Compared_with_Traditional_ACL_Rehabilitation_Protocol

(PDF) Effectiveness of Blood Flow Restriction Training on ... Conclusion: Blood flow restriction training was found to be more effective than strengthening exercise for thetreatment of post rehabilitation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811521/

Blood Flow Restriction Therapy and Its Use for ... Blood flow restriction (BFR) is an expanding rehabilitation modality that uses a tourniquet to reduce arterial inflow and occlude venous outflow.

7. airbandsbfr.com airbandsbfr.com/products/bfr-bands?srsltid=AfmBOoo-MA_FekCOYI4boHuDtrWuFZQTrG1NvYoKCX7iqMejIIvYlt7v

AirBands 2.0 AirBands is revolutionizing Blood Flow Restriction training for health and performance professionals with an affordable, easy to use BFR solution. Wireless ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8191295/

Biomechanical Effects of Blood Flow Restriction Training After ... There remains limited prospective long-term data on the efficacy and safety of BFR after ACL reconstruction. The present study demonstrates that BFR leads to ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0749806324001774

Blood Flow Restriction Therapy After Anterior Cruciate ... Blood flow restriction (BFR) therapy involves performing exercises while a specialized blood pressure cuff is applied to the proximal aspect of the operative ...