Blood Flow Restriction Therapy for Hip Fracture

Overseen By Matthew C Hess, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Blood thinners

Disqualifiers: DVT, Cancer, Dementia, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help older adults recover after hip surgery. Participants will receive either standard physical therapy or physical therapy enhanced with blood flow restriction (using a cuff to temporarily reduce blood flow) and electrical stimulation to determine if these additional methods improve recovery. It targets individuals aged 65 or older who recently underwent surgery for a specific type of hip fracture and were living independently and walking unaided before their injury. As an unphased trial, this study allows participants to contribute to innovative recovery methods that could enhance future treatments.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using any medication or supplement that may increase blood clotting risk, you may be excluded from participating.

What prior data suggests that the Delfi Tourniquet System Cuff is safe for elderly patients after hip fracture surgery?

Research has shown that blood flow restriction (BFR) therapy is generally safe for recovery after surgery. Studies have demonstrated that the Delfi Tourniquet System, used in BFR, safely manages pressure on the limb, reducing the risk of harm.

In studies with older patients recovering from hip fractures, BFR therapy proved to be low-risk and noninvasive. It helps prevent muscle loss and improves strength. Additionally, combining neuromuscular electrical stimulation (NMES) with BFR has been well-tolerated, with no major side effects reported.

While all medical treatments carry some risk, current evidence supports the safety of using the Delfi Tourniquet System with NMES in post-surgery rehabilitation for hip fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Blood Flow Restriction (BFR) therapy combined with Neuromuscular Electrical Stimulation (NMES) for hip fractures because it introduces a novel approach to rehabilitation. Unlike standard physical therapy, which primarily focuses on gradual exercise progression, this method uses a Delfi Tourniquet System Cuff to restrict blood flow, potentially enhancing muscle strength and recovery by simulating intense exercise with lighter loads. Additionally, the integration of NMES works to stimulate muscles electrically, which can further accelerate muscle recovery and strength gains without overstraining the patient. This combination of techniques offers a fresh strategy that might speed up recovery and improve outcomes compared to conventional rehabilitation methods.

What evidence suggests that blood flow restriction therapy is effective for hip fracture recovery?

Research has shown that blood flow restriction (BFR) therapy can help build muscle strength when combined with light weight training. In this trial, one group will receive routine physical therapy combined with BFR using the Delfi tourniquet system and neuromuscular electrical stimulation (NMES). A study found that BFR with physical therapy improved muscle strength and size more than regular therapy alone. This method reduces stress on joints while still increasing strength. Additionally, using NMES with BFR might further boost muscle activity and recovery. These techniques seem promising for aiding recovery from hip fractures by improving muscle function and overall rehabilitation outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

David A Patch, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Elderly patients aged 65 or older who have had surgery for a hip fracture can join this trial. They must have been able to walk half a mile before the injury, speak English, and be capable of light exercise. Those with severe obesity, uncontrolled high blood pressure, recent surgeries on legs, COVID-19 infection, history of deep vein thrombosis (DVT), or conditions increasing coagulopathy risk cannot participate.

Inclusion Criteria

You can walk about 0.5 mile without feeling much pain or getting too out of breath.

I have a hip fracture that hasn't been operated on or has no implants.

I do not have a broken thigh bone due to disease.

Exclusion Criteria

You have severe obesity with a body mass index (BMI) over 40.

I do not have severe issues that would prevent me from following up on treatment.

I have a history of sickle cell anemia, peripheral arterial disease, dementia, or actively treated cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive routine post-operative physical therapy or routine physical therapy with blood flow restriction and neuromuscular electrical stimulation for 2 weeks

2 weeks

5 visits per week (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, muscle strength, and functional recovery

2 weeks

Extension

Potential for a larger 8-week intervention study based on pilot study results

What Are the Treatments Tested in This Trial?

Interventions

• Delfi Tourniquet System Cuff

Trial Overview

The study is testing if adding Blood Flow Restriction therapy to regular post-surgery physical therapy helps elderly patients recover better from hip fractures. Participants will use the Delfi Tourniquet System Cuff during their rehabilitation exercises.

How Is the Trial Designed?

Group I: Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES) Experimental Treatment 1 Intervention

The intervention group will start with a Delfi tourniquet system cuff set on a limb occlusion pressure (LOP) of 60-100%. The intervention group will also use a neuromuscular electrical stimulation device at therapeutic level in addition to BFR.

Group II: Routine Post-operative Physical Therapy Active Control 1 Intervention

The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Blood flow restriction (BFR) training, when combined with traditional resistance training, can significantly enhance strength in healthy athletes, with 78% of studies showing notable improvements compared to control groups.

BFR training also has the potential to increase muscle size and improve sport-specific performance metrics, with 50% of studies reporting muscle size gains and 75% showing enhancements in athletic performance measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for Athletes: A Systematic Review. Wortman, RJ., Brown, SM., Savage-Elliott, I., et al.[2021]

Tourniquets are effective in providing blood-free surgical fields in orthopaedic surgery, but they carry risks of nerve, muscle, and tissue injuries; however, advancements in tourniquet technology have reduced these risks by lowering pressure levels.

Recent evidence shows that tourniquets can also be used for blood flow restriction (BFR) therapy, which helps reduce muscle atrophy and improve strength, thus enhancing recovery outcomes when used appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tourniquet-induced nerve compression injuries are caused by high pressure levels and gradients - a review of the evidence to guide safe surgical, pre-hospital and blood flow restriction usage. Masri, BA., Eisen, A., Duncan, CP., et al.[2020]

In a study of 29 participants, a minimum blood flow restriction pressure of 50% limb occlusion pressure (LOP) was necessary to significantly reduce arterial blood flow in the lower limbs, indicating a threshold for effective blood flow restriction.

The study found no significant differences in vessel diameter or blood flow at higher occlusion pressures (60% to 90% LOP), suggesting that pressures above 50% LOP may not provide additional benefits for blood flow restriction during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Blood Flow Responses to Varying Blood Flow Restriction Pressures in the Lower Limb. Hornikel, B., Saffold, KS., Mota, JA., et al.[2023]

In a study of 46 subjects over 8 weeks, both blood flow restriction (BFR) training and traditional exercise led to significant strength gains in the rotator cuff muscles, but there was no difference in strength improvements between the two methods.

Both groups also experienced increases in supraspinatus tendon thickness, indicating that low-load, high-repetition exercises can effectively enhance rotator cuff strength and tendon size, regardless of BFR application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. Brumitt, J., Hutchison, MK., Kang, D., et al.[2023]

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[2023]

A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.

BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Citations

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A 4-week supervised rehabilitation combined with BFR is more effective in improving muscle strength and size and functional performance compared with the ...

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However, other studies have reported similar outcomes with LI-BFR and LI training in bone health improvements. While some studies have explored ...

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PTS for BFR System - Delfi Medical

The PTS Personalized Tourniquet System for Blood Flow Restriction (BFR) has been specifically designed to safely regulate and control tourniquet pressure.

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In those circumstances, it is a low risk and noninvasive technique. By limiting muscle atrophy and aiding in the recovery of strength and function, it has the ...

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The Role of Blood Flow Restriction Therapy in Postoperati...

This is a prospective, randomized blinded 2-week study of elderly patients recovering from surgical treatment of hip fractures with two arms: 1) ...