Blood Flow Restriction Training for Knee Instability

(BRAINS Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Caitin Conley

Disqualifiers: Osteochondral lesion, Osteoarthritis, Knee surgery, Inflammatory disorder, Diabetes, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether using an air cuff to limit blood flow during physical therapy helps people with unstable kneecaps recover faster. Patients will receive either regular physical therapy or regular therapy plus this new method. The goal is to see if this approach helps muscles get stronger more quickly.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have diabetes or uncontrolled hypertension, you are not eligible to participate.

What data supports the effectiveness of the treatment Blood Flow Restriction Training for knee instability?

Research shows that Blood Flow Restriction Training (BFRT) can help improve knee strength and reduce muscle loss in various knee conditions, such as after knee surgery or in knee osteoarthritis. It has also been found to decrease knee pain more effectively than regular resistance training alone. ^{1 2 3 4 5}

Is Blood Flow Restriction Training generally safe for humans?

Blood Flow Restriction Training (BFRT) has been shown to be relatively safe in healthy populations over the past 25 years, according to numerous studies. ^{2 3 5 6 7}

How is Blood Flow Restriction Training different from other treatments for knee instability?

Blood Flow Restriction Training (BFRT) is unique because it uses a cuff to partially restrict blood flow, allowing for muscle strengthening with lighter weights, which is beneficial for those who cannot handle heavy loads after knee surgery or injury. This approach can help reduce muscle loss and improve strength more effectively than traditional heavy strength training, especially in early rehabilitation stages. ^{2 4 5 7 8}

Research Team

Caitlin Conley, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for individuals aged 14-40 with closed growth plates and traumatic patellar instability, who are active in sports like tennis or skiing at least once a week. They must want to return to their pre-injury activity level. Excluded are those with certain knee conditions, surgeries, high BMI (>35), varicose veins, history of deep vein thrombosis in the family, planned long absences during the trial period, diabetes or uncontrolled hypertension.

Inclusion Criteria

My bones have finished growing, as confirmed by an X-ray.

I want to return to my activity level before my injury.

You are physically active and engage in sports activities like running, tennis, or skiing at least 1-3 times per week.

Exclusion Criteria

My last episode of instability was over 3 months ago.

I have varicose veins or a family history of deep vein thrombosis.

Your body mass index (BMI) is higher than 35, which means you are significantly overweight.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo 8 weeks of either standard physical therapy or standard physical therapy with blood flow restriction training (BFRT).

8 weeks

4 visits (in-person) at weeks 1, 5, 9, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee and hip strength, biomechanics, and MRI evaluations.

24 months

3 visits (in-person) at 1 year, 2 years, and additional assessments

Treatment Details

Interventions

• Blood Flow Restriction Training (Behavioural Intervention)

Trial Overview The study tests blood flow restriction training (BFRT) against sham BFRT to see if it helps recovery from patellar instability. Participants will be randomly assigned to either real BFRT or a placebo-like version without actual restriction to compare outcomes.

Participant Groups

Group I: Standard Physical Therapy with Sham BFRT Active Control 1 Intervention

Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.

Group II: Standard Physical Therapy with BFRT Active Control 1 Intervention

Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.

Blood Flow Restriction Training is already approved in Japan for the following indications:

Approved in Japan as KAATSU Training for:

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

Who Is Running the Clinical Trial?

Caitin Conley

Lead Sponsor

Trials

1

Recruited

80+

Cale Jacobs, PhD

Lead Sponsor

Trials

5

Recruited

140+

Caitlin Conley

Lead Sponsor

Trials

1

Recruited

80+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Findings from Research

This study is investigating the effectiveness of blood-flow restriction training (BFRT) for improving outcomes in 78 patients with acute patellar dislocations, aiming to enhance recovery and prevent long-term joint issues.

The trial will compare BFRT to a sham treatment alongside standard physical therapy, focusing on patient-reported outcomes, quadriceps strength, and cartilage health, addressing a gap in current rehabilitation practices for patellar instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow Restriction training After patellar INStability (BRAINS Trial). Brightwell, BD., Stone, A., Li, X., et al.[2022]

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 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 after knee surgery significantly improves the cross-sectional area of the quadriceps muscle, indicating reduced muscle atrophy, based on a systematic review of 11 studies.

However, there were no significant improvements in patient-reported outcomes, and preoperative BFR training did not show clinical benefits, suggesting that while BFR is effective post-surgery, its role before surgery needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Wengle, L., Migliorini, F., Leroux, T., et al.[2022]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

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]

Blood flow restriction low load strength training (BFR-LLST) is feasible for patients recovering from knee cartilage or meniscus repair, with over 84% adherence to the program over 9 weeks.

No serious adverse events were reported during the study, indicating that BFR-LLST is a safe addition to usual care exercise, potentially preventing muscle atrophy without increasing pain or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction added to usual care exercise in patients with early weight bearing restrictions after cartilage or meniscus repair in the knee joint: a feasibility study. Jakobsen, TL., Thorborg, K., Fisker, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Low load resistance training with blood flow restriction decreases anterior knee pain more than resistance training alone. A pilot randomised controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Blood flow Restriction training After patellar INStability (BRAINS Trial). [2022]

3. 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]

4. 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]

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

The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. [2022]

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

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

Blood flow restriction added to usual care exercise in patients with early weight bearing restrictions after cartilage or meniscus repair in the knee joint: a feasibility study. [2022]