What is the mechanism of action of this treatment?

Blood Flow Restriction (BFR) therapy involves restricting blood flow to muscles during low-intensity exercise, promoting muscle hypertrophy and strength gains similar to high-intensity training. This method is beneficial for patients who cannot tolerate high-intensity workouts due to pain or other limitations. BFR creates a hypoxic environment that stimulates muscle protein synthesis and increases growth hormone release, leading to improved muscle strength and recovery. This is crucial for muscle weakness patients as it provides an effective and less strenuous alternative to traditional strength training, enhancing rehabilitation outcomes.

What side effects are associated with this type of intervention?

Blood Flow Restriction (BFR) therapy, used in muscle weakness treatment, can lead to several side effects. These include increased neuromuscular fatigue, as indicated by greater decreases in voluntary activation and surface electromyography amplitude. Additionally, patients may experience discomfort, pain, and a potential risk of blood clot formation due to restricted blood flow. Other common treatments for muscle weakness, such as resistance training, may cause muscle soreness, joint pain, and in some cases, overuse injuries. It is essential to monitor these side effects and consult with a healthcare provider to ensure safe and effective treatment.

What prior FDA approvals exist?

FDA approvals for the treatment of muscle weakness have included various pharmacological and therapeutic approaches. While specific FDA-approved drugs directly analogous to blood flow restriction (BFR) therapy are not detailed, treatments like physical therapy and resistance training are commonly recommended for muscle weakness. BFR therapy itself is an emerging technique in rehabilitation, showing promise in enhancing muscle strength and recovery post-surgery, such as knee arthroscopy. Other related treatments may include anabolic agents or neuromuscular electrical stimulation, which aim to improve muscle mass and function.

What other types of research exist?

Promising novel alternatives to Blood Flow Restriction (BFR) therapy for muscle weakness patients include: 1) Neuromuscular Electrical Stimulation (NMES), which uses electrical impulses to stimulate muscle contractions and improve strength. 2) Regenerative Medicine approaches such as stem cell therapy and platelet-rich plasma (PRP) injections, which aim to repair and regenerate damaged muscle tissue. 3) Advanced resistance training techniques, including eccentric training and high-intensity interval training (HIIT), which have been shown to enhance muscle strength and endurance. 4) Virtual Reality (VR)-based rehabilitation programs that provide immersive and engaging environments to promote muscle recovery and adherence to exercise regimens.

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BFR Therapy for Post-Knee Arthroscopy Recovery (ACL BFR Trial)

N/A

Recruiting

Led By James Genuario, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Patients with ACL reconstruction with quadriceps, hamstring, bone-patellar-bone or allograft graft, with/without meniscectomies

Be younger than 65 years old

Must not have

Untreated Hypertension

Untreated Hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial investigates if using Blood Flow Restriction (BFR) therapy can help patients recover faster and stronger after knee surgery. BFR uses a special cuff to limit blood flow during exercise, making muscles grow and strengthen with less effort. The goal is to see if this method improves recovery better than standard rehabilitation alone.

Who is the study for?

This trial is for patients who've had knee arthroscopy and are rehabilitating from ACL reconstruction. They must be able to use a smartphone with the SAGA BFR app. It's not for those with MCL repairs, clotting disorders, recent severe cardiovascular or brain events, untreated blood pressure issues, pregnancy/postpartum within 6 months, poor English understanding, recent major injuries or surgeries on both knees close together.

What is being tested?

The study tests how effective blood flow restriction (BFR) therapy is when used in rehabilitation after knee surgery. Participants will use a BFR cuff along with an application that guides them through the process.

What are the potential side effects?

Potential side effects of using the BFR cuff may include discomfort at the site of application, temporary numbness or tingling in the limb due to restricted blood flow, muscle fatigue during exercise and possible bruising.

Eligibility Criteria

Inclusion Criteria

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

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I had ACL surgery using tissue from my body or a donor, with or without meniscus removal.

Exclusion Criteria

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

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I have high blood pressure that hasn't been treated.

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I have low blood pressure that hasn't been treated.

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I have had a recent severe muscle injury or trauma.

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I have had a deep vein thrombosis.

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I have hemophilia or am on blood thinners.

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I have had a pulmonary embolism.

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I do not understand English.

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I have a blood clotting disorder.

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I have had surgery to repair my meniscus.

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I have had surgery to repair or transplant cartilage.

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My ACL surgery will use tissue from the opposite side of my body.

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I have had a stroke caused by bleeding in the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Knee extensor strength

Secondary study objectives

ACL-RSI

Brief Resiliency Score (BRS)

IKDC

+7 more

Trial Design

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Participants undergo standard post-operative physical therapy as prescribed by their surgeon.

Group II: BFR CuffActive Control1 Intervention

Patients undergo standard post-operative physical therapy as prescribed by their surgeon with the addition of a Blood Flow Restriction (BFR) cuff that is used during their exercises.

0 / 13Eligibility 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 (BFR) therapy involves restricting blood flow to muscles during low-intensity exercise, promoting muscle hypertrophy and strength gains similar to high-intensity training. This method is beneficial for patients who cannot tolerate high-intensity workouts due to pain or other limitations. BFR creates a hypoxic environment that stimulates muscle protein synthesis and increases growth hormone release, leading to improved muscle strength and recovery. This is crucial for muscle weakness patients as it provides an effective and less strenuous alternative to traditional strength training, enhancing rehabilitation outcomes.

Restricted Blood Flow Exercise in Sedentary, Overweight African-American Females May Increase Muscle Strength and Decrease Endothelial Function and Vascular Autoregulation.Legs and trunk muscle hypertrophy following walk training with restricted leg muscle blood flow.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,786 Previous Clinical Trials

2,787,530 Total Patients Enrolled

1 Trials studying Muscle Weakness

70 Patients Enrolled for Muscle Weakness

James Genuario, MDPrincipal InvestigatorUniversity of Colorado, Denver

3 Previous Clinical Trials

131 Total Patients Enrolled

Media Library

BFR Cuff Clinical Trial Eligibility Overview. Trial Name: NCT05735236 — N/A

Muscle Weakness Research Study Groups: Control, BFR Cuff

Muscle Weakness Clinical Trial 2023: BFR Cuff Highlights & Side Effects. Trial Name: NCT05735236 — N/A

BFR Cuff 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735236 — N/A

~28 spots leftby Nov 2025

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