128 Participants Needed

Blood Flow Restriction Therapy for Lower Limb Injury

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Overseen BySamy Shelbaya
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called blood flow restriction therapy, which uses a special cuff on the leg to limit blood flow, potentially improving strength and muscle mass in individuals with lower leg injuries like tendon ruptures. The study will compare this therapy to a placebo version to determine its effectiveness. Suitable candidates for this trial are those with a lower leg extensor injury who plan to undergo physical therapy.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that blood flow restriction therapy is safe for lower limb injuries?

Research has shown that blood flow restriction therapy (BFRT) is generally well-tolerated. Studies have found that this therapy can improve muscle strength and reduce pain during recovery. For instance, one study found that it led to strength gains similar to those from traditional weightlifting, suggesting its safety.

While some discomfort from the cuff's pressure may occur, studies have not reported any serious side effects. The therapy involves placing a cuff around the leg to limit blood flow, but it is carefully controlled to prevent major issues. Overall, people handle this treatment well, and it could be a useful option for building strength after an injury.12345

Why are researchers excited about this trial?

Unlike traditional treatments for lower limb injuries, which often involve physical therapy or surgery, blood flow restriction therapy (BFRT) uses a pressure cuff to limit blood flow to the injured area. This technique is unique because it allows for muscle strengthening and recovery with lower intensity exercises, which can be less taxing on the body. Researchers are excited about BFRT because it has the potential to accelerate rehabilitation times by enhancing muscle growth and strength without the need for heavy weights or strenuous activity. Additionally, the therapy's ability to specifically target the injured area with controlled pressure could lead to more efficient and effective recovery outcomes.

What evidence suggests that blood flow restriction therapy is effective for lower limb injuries?

Research has shown that blood flow restriction therapy can enhance muscle strength and size. This therapy uses a cuff to limit blood flow to the muscles, promoting growth even with lighter exercises. Evidence suggests it can also reduce pain and improve function more effectively than regular resistance training. In this trial, participants will receive either the experimental blood flow restriction therapy, which limits approximately 80% of arterial blood flow using a pressure cuff, or a placebo version with a lower pressure setting. For individuals with leg injuries, this method increased strength and reduced pain. In athletes, combining this therapy with other training led to greater muscle strength improvements. Overall, this approach has shown promise for muscle recovery and growth.12467

Who Is on the Research Team?

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Guillem Gonzales-Lomas, MD

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with lower limb extensor injuries who plan to undergo physical therapy. It's not suitable for those under 18 or over 65, mentally impaired individuals, people using mobility aids before injury, patients with prior similar injuries, circulation issues, severe hypertension, additional leg trauma, sickle cell anemia, venous thromboembolism or cancer.

Inclusion Criteria

I have an injury to my lower limb's extensor (like a torn quadriceps or patella tendon, or a broken kneecap).
ASA class I-II
I plan to undergo physical therapy as part of my treatment.

Exclusion Criteria

Any patient considered a vulnerable subject
I am legally competent and mentally sound.
I plan to receive the standard treatment, not the study therapy.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo blood flow restriction therapy with a pressure cuff to enhance muscle hypertrophy and rehabilitation

6 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction Therapy
Trial Overview The study tests the effectiveness of blood flow restriction therapy in treating lower limb extensor injuries. Participants will receive physical therapy either with a pressure cuff that restricts blood flow or a placebo cuff without this effect to compare results on muscle strength and mass.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: blood flow restriction therapy (pressure cuff)Experimental Treatment1 Intervention
Group II: blood flow restriction therapy (placebo)Placebo Group1 Intervention

Blood Flow Restriction Therapy is already approved in United States, Japan, European Union for the following indications:

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Approved in United States as Blood Flow Restriction Therapy for:
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Approved in Japan as KAATSU Training for:
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Approved in European Union as Blood Flow Restriction Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.
The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.
Use of Blood Flow Restriction Training for Postoperative Rehabilitation.Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]
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.
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]
Resistance training with blood flow restriction (BFR) at low loads can produce muscle fatigue comparable to high-load training, with 21 participants showing that 20% maximal voluntary contraction (MVC) with continuous partial occlusion caused greater fatigue than high-load training (31% vs 19% decrement in MVC).
The study suggests that specific BFR protocols, particularly the 20% MVC with continuous partial occlusion, may be more effective for muscle fatigue than other BFR methods or high-load training, indicating potential for optimizing resistance training strategies.
Effects of exercise load and blood-flow restriction on skeletal muscle function.Cook, SB., Clark, BC., Ploutz-Snyder, LL.[2022]

Citations

Blood Flow Restriction Training - PMCEvidence suggests that blood flow restriction training can improve function and pain outcomes beyond traditional resistance training in individuals with joint ...
Blood Flow Restriction Training: A Tool to Enhance ...Blood flow restriction training (BFRT) is a tool utilized in rehabilitation and injury prevention to improve muscle strength and size.
The effect of blood flow restriction training on core muscle ...Four weeks of LL-BFRT significantly reduced pain and functional disability while inducing similar strength gains as HL-RT in male collegiate athletes with ...
Blood Flow Restriction Therapy to Optimize Muscle Size ...This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone).
The effects of blood flow restriction combined with endurance ...With the addition of BFR to endurance training, athletes will experience greater gains in lower limb muscle strength and V̇O2max. However, ...
Effects of blood flow restriction training on physical fitness ...Our results revealed that the BFRT intervention had small to large improvements in the athletes' strength (ES = 0.74–1.03), power (ES = 0.46), ...
Blood flow restriction training and the exercise pressor reflexDuring BFR training, blood flow to the exercising muscle is mechanically restricted by placing flexible pressurizing cuffs around the active limb proximal to ...
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