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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age \>= 65) after recovering from surgical treatment of hip fractures.

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.

Is Blood Flow Restriction Therapy generally safe for humans?

Blood Flow Restriction Therapy, which uses a tourniquet to limit blood flow, is generally safe when used correctly, but it can pose risks like nerve or muscle injury if not properly managed. Advances in tourniquet technology have improved safety by reducing these risks. ^{1 2 3 4 5}

How does blood flow restriction therapy differ from other treatments for hip fracture?

Blood flow restriction therapy is unique because it uses a cuff to partially restrict blood flow in the limbs, creating a low-oxygen environment that helps improve muscle strength and function. This approach is different from traditional rehabilitation methods, which do not typically involve altering blood flow to enhance recovery. ^{2 3 4 5 6}

Research Team

David A Patch, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2020]

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

Blood Flow Restriction Training for Athletes: A Systematic Review. [2021]

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

Acute Blood Flow Responses to Varying Blood Flow Restriction Pressures in the Lower Limb. [2023]

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

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. [2023]

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

Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]