BFR Training for ACL Recovery

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Rachel Perry, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Must not be taking: Anticoagulants

Disqualifiers: Cardiovascular, Diabetes, Rheumatoid arthritis, others

No Placebo Group

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. ^{2 4 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}

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.

Trial 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 (Behavioural Intervention)

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,

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale New Haven Hospital Milford, CT

Gaylord Outpatient Physical Therapy North Haven Clinic North Haven, CT

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

References

1. 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] More than 2 million anterior cruciate ligament (ACL) injuries occur worldwide each year. Most surgeons suggest that athletes and active persons with significant knee functional demands, including cutting motions, require and should be offered ligament reconstruction surgery. Despite concentrated rehabilitation efforts, deficits in quadriceps size and strength can persist for years after surgery. Blood flow restriction (BFR) training can help overcome disuse muscular atrophy in the mid-term postoperative period after anterior cruciate ligament reconstruction (ACLR) surgery. The purpose of this study was to evaluate the effects of quadriceps training with different levels of blood flow restriction on quadriceps strength and thickness of participants after ACLR.

2. 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] Blood flow restriction training (BFRT) after anterior cruciate ligament reconstruction (ACLR) is rising in popularity because of its benefits in reducing muscle atrophy and mitigating knee strength deficits.

3. 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] ACL reconstruction often results in an extended period of muscle atrophy and weakness. Blood flow restriction (BFR) training is a technique that has been shown to decrease muscle atrophy in a variety of populations.

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

Blood flow restriction training in South Africa - a panel discussion. [2023] Blood flow restriction (BFR) training uses a cuff to partially occlude venous blood flow and improve musculoskeletal training outcomes. Over the past 25 years, numerous studies have demonstrated its relative safety and efficacy.

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] Anterior cruciate ligament tears or ruptures are common orthopedic injuries. Anterior cruciate ligament reconstruction (ACLR) is an orthopedic procedure allowing for earlier return to sports, improved maintenance of lifestyle demands, and restored knee stability and kinematics. A perioperative rehabilitative adjunct recently gaining interest is blood flow restriction (BFR), a method in which temporary restriction of blood flow to a chosen extremity is introduced and can be used as early as a few days postoperative. There has been increasing investigation and recent literature regarding BFR. This review synthesizes current concepts of BFR use in the ACLR perioperative period. [Orthopedics. 2023;46(6):e333-e340.].

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] Blood Flow Restriction (BFR) training has gained popularity as a novel training strategy in athletes and rehabilitation settings in recent years.

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] Blood flow restriction (BFR) training involves low-weight exercises performed under vascular occlusion via an inflatable cuff. For patients who cannot tolerate high-load exercises, BFR training reportedly provides the benefits of high-load regimens, with the advantage of less tissue and joint stress.

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

Blood Flow Restriction Training for Athletes: A Systematic Review. [2021] Blood flow restriction (BFR) is a novel technique involving the use of a cuff/tourniquet system positioned around the proximal end of an extremity to maintain arterial flow while restricting venous return.