What side effects are associated with this type of intervention?

Common treatments for leg injuries similar to Blood Flow Restriction Training (BFRT) include physical therapy, eccentric exercises, and resistance training. Known side effects of these treatments can include muscle soreness, fatigue, and, in some cases, delayed onset muscle soreness (DOMS). Additionally, improper technique or overuse can lead to muscle strains or exacerbation of existing injuries. For BFRT specifically, potential side effects may include discomfort from the restriction bands, bruising, and a temporary increase in blood pressure. It is important to perform these exercises under professional supervision to minimize risks.

What prior FDA approvals exist?

There are no specific FDA-approved drugs that directly mimic the mechanism of Blood Flow Restriction Training (BFRT) for the treatment of leg injuries. However, various physical therapy techniques, including supervised exercise programs, have been recognized for their effectiveness in improving muscle strength and recovery in conditions like peripheral artery disease. Additionally, treatments such as platelet-rich plasma (PRP) injections and stem cell therapies are being investigated for their potential benefits in muscle and tendon recovery, although they are not yet widely approved for these specific uses.

What other types of research exist?

Promising novel alternatives to Blood Flow Restriction Training (BFRT) for leg injury patients include: 1) Platelet-Rich Plasma (PRP) injections, which have shown benefits in treating various tendinopathies and muscle injuries by promoting healing and reducing pain. 2) Extracorporeal Shock Wave Therapy (ESWT), which has been effective in enhancing tissue regeneration and reducing pain in tendinopathies. 3) Autologous Blood Injections, which have demonstrated efficacy in resistant tendinopathies by promoting healing through growth factors. These therapies offer potential benefits in muscle strength and recovery for leg injury patients.

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Behavioural Intervention

Blood Flow Restriction Training for Knee Instability (BRAINS Trial)

N/A

Recruiting

Research Sponsored by Caitin Conley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Skeletally mature with closed growth plates visualized by radiograph

Age 14 to 40 years

Must not have

History of any inflammatory disorder

Concomitant osteochondral lesion requiring surgical fixation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort due to restricted blood flow during training sessions and possible muscle fatigue post-training. There might also be risks associated with wearing the device used for restricting blood flow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 14 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of an inflammatory disorder.

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I need surgery for a bone and cartilage injury.

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I have conditions or past surgeries that affect my walking.

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I have had surgery on one or both of my knees before.

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I have diabetes or high blood pressure that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

MRI Muscle Volume

MRI T1rho

Quadriceps Strength Symmetry

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard Physical Therapy with Sham BFRTActive Control1 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 BFRTActive Control1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Blood Flow Restriction Training (BFRT) enhances muscle strength and recovery by restricting blood flow to muscles during exercise, creating a hypoxic environment that increases muscle fiber recruitment and metabolic stress. This leads to greater muscle hypertrophy and strength gains, and stimulates the release of growth factors and anabolic hormones, promoting muscle repair and growth. For leg injury patients, BFRT allows effective muscle strengthening and rehabilitation with lower exercise intensities, reducing the risk of further injury while achieving significant therapeutic benefits.