BFR Therapy for Hip Surgery Rehabilitation

Overseen By Lauren M Heylmun, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Blood thinners

Disqualifiers: Bilateral hip surgeries, Hip dysplasia, DVT, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehabilitation method using blood flow restriction (BFR) therapy to determine its effectiveness in improving recovery after hip surgery. BFR involves using special cuffs during physical therapy to limit blood flow, potentially enhancing recovery. Participants will either use BFR cuffs with their usual therapy or continue their normal post-surgery rehabilitation routine. Ideal candidates are those undergoing hip arthroscopy for conditions like labral tears or femoroacetabular impingement syndrome and who can use a smartphone app. As an unphased trial, this study provides an opportunity to explore innovative rehabilitation methods that could enhance the recovery experience.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are taking blood thinners, you may not be eligible to participate.

What prior data suggests that this BFR therapy is safe for hip surgery rehabilitation?

A previous study found blood flow restriction (BFR) therapy to be generally safe with few side effects. Most people tolerate it well, though sessions occasionally stop due to discomfort or pressure issues on the arms or legs. Research has also shown that BFR does not increase the risk of blood clots, which reassures its safety. Overall, BFR therapy appears to be a well-tolerated option for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BFR (Blood Flow Restriction) therapy for hip surgery rehabilitation because it offers a novel approach by incorporating BFR cuffs into exercise routines. Unlike standard physical therapy, which usually involves typical exercises to strengthen muscles, BFR therapy uses cuffs to restrict blood flow during low-intensity exercises, potentially enhancing muscle strength and recovery with less strain. This unique mechanism allows patients to achieve results similar to high-intensity workouts, which is especially beneficial for those recovering from surgery and unable to perform more strenuous activities.

What evidence suggests that BFR therapy is effective for hip surgery rehabilitation?

Research has shown that Blood Flow Restriction (BFR) therapy can improve muscle strength and function after surgeries, such as hip surgeries. In this trial, participants in the BFR Group will receive BFR therapy, which previous studies have shown helps people recovering from hip surgery grow and strengthen their muscles. One study found that even those with very weak thigh muscles gained significant strength after several BFR sessions. BFR therapy also boosts overall muscle endurance and function for various muscle and bone injuries. These findings suggest that BFR therapy could aid recovery after surgery, allowing patients to regain strength more quickly. ^{1 5 6 7 8}

Who Is on the Research Team?

James Genuario, MD

Principal Investigator

University of Colorado SOM

Are You a Good Fit for This Trial?

This trial is for individuals with hip injuries like labral tears or femoroacetabular impingement, who are undergoing hip arthroscopy. Participants need to have a smartphone to use the free SAGA BFR app. It's not for those with untreated low blood pressure, recent severe muscle injury, planned bilateral hip surgeries close together, certain hip conditions, clotting disorders, pregnancy up to 6 months post-partum, or untreated high blood pressure.

Inclusion Criteria

I have a hip condition that requires surgery.

Patients must have access to a smartphone device in order to utilize the SAGA BFR application for use. The application is free to use.

Exclusion Criteria

I don't have clotting issues, untreated blood pressure problems, recent severe injuries, or am not pregnant/recently gave birth.

I have had surgery to repair my hamstring or glutes.

I am undergoing or have undergone a specific hip surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Post-operative rehabilitation with BFR therapy, focusing on initial recovery exercises

3 weeks

6 visits (in-person) for BFR training, 3 visits (in-person) for PT

Treatment Phase 2

Continuation of BFR therapy with progressive resistive exercises

3 weeks

3 visits (in-person) for BFR training, 3 visits (in-person) for PT

Treatment Phase 3

Advanced BFR therapy with increased resistance and complex exercises

6 weeks

6 visits (in-person) for BFR training, 6 visits (in-person) for PT

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 months

What Are the Treatments Tested in This Trial?

Interventions

• BFR

Trial Overview The study tests the effectiveness of Blood Flow Restriction (BFR) therapy during rehabilitation after hip surgery. The intervention group will use BFR cuffs provided by SAGA alongside standard physical therapy practices and track progress using an app.

How Is the Trial Designed?

Group I: BFR Group Experimental Treatment 1 Intervention

BFR cuffs will be used for specific exercises and added to the current SOC for post hip scope PT.

Group II: SOC Group Active Control 1 Intervention

Current SOC for post hip scope PT will be assigned.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Blood flow restriction (BFR) training allows patients to safely exercise with low resistance after knee surgery, promoting muscle growth and strength despite reduced oxygen delivery to muscle cells.

Orthopaedic surgeons and physical therapists are increasingly using BFR in rehabilitation protocols, highlighting its effectiveness in postoperative recovery for knee injuries and surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. DePhillipo, NN., Kennedy, MI., Aman, ZS., et al.[2020]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]

Blood flow restriction training (BFRT) does not show significantly greater efficacy than conventional resistance training for treating knee osteoarthritis, based on a meta-analysis of 5 studies with low to moderate risk of bias.

BFRT may have a lower incidence of adverse events compared to high-load resistance training, suggesting it could be a safer option for patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Wang, HN., Chen, Y., Cheng, L., et al.[2022]

Blood flow restriction (BFR) therapy can enhance skeletal muscle adaptations, making it a beneficial method for both civilian and military populations during rehabilitation.

BFR therapy allows patients to safely start strength training earlier in their recovery, potentially leading to quicker returns to activity and improved military readiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: From Development to Applications. Anderson, AB., Owens, JG., Patterson, SD., et al.[2020]

Blood Flow Restriction Training (BFRT) is an effective and innovative rehabilitation technique that can prevent muscle atrophy in post-surgical patients during initial bed rest, improving muscle function, strength, and mass.

BFRT, when combined with aerobic activities, not only enhances muscle strength but also improves cardiovascular fitness, making it a versatile treatment option for various conditions related to muscle weakness and degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training-An Overview and Implication in New Generation Physical Therapy: A Narrative Review. Saraf, A., Goyal, M., Goyal, K.[2022]

Low-load blood flow restriction (BFR) training, when combined with standard rehabilitation, showed significant improvements in muscle endurance and blood flow in patients undergoing anterior cruciate ligament reconstruction (ACLR), particularly noted in a preoperative study with a significant increase in muscle isometric endurance and blood flow to the vastus lateralis.

Postoperative BFR training demonstrated notable benefits in muscle hypertrophy and strength compared to traditional low-load resistance training, indicating that BFR could enhance recovery outcomes after ACLR, although more research is needed to confirm these findings due to the limited number of studies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Lu, Y., Patel, BH., Kym, C., et al.[2022]

A randomized controlled trial with 26 healthy participants showed that low-load blood flow restriction (BFR) training significantly increased muscle strength and limb circumference compared to a control group, with no reported adverse events.

BFR training was effective for strengthening muscle groups both proximal and distal to the tourniquet, and even improved strength in the non-restricted extremity, suggesting a systemic benefit from this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Bowman, EN., Elshaar, R., Milligan, H., et al.[2020]

Blood flow restriction training (BFRT) significantly improved muscle strength in patients with severe quadriceps and hamstring deficits after traditional rehabilitation failed, with notable increases in peak torque observed after just 9 sessions.

In a study of 27 patients who had undergone various knee surgeries, 86% showed over 20% improvement in quadriceps strength and 76% in hamstring strength after 18 BFRT sessions, indicating its efficacy as a rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training Can Improve Peak Torque Strength in Chronic Atrophic Postoperative Quadriceps and Hamstrings Muscles. Noyes, FR., Barber-Westin, SD., Sipes, L.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04113759

Blood Flow Restriction Following Hip Arthroscopy This study will evaluate the efficacy of BFR therapy in the postoperative period of primary hip arthroscopy to improve muscle hypertrophy during the short-term ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811521/

Blood Flow Restriction Therapy and Its Use for ... In individuals with severe chronic thigh weakness after knee surgery the majority made significant increases in strength after just 9 BFR sessions. In addition, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030811/

Survey of blood flow restriction therapy for rehabilitation in ... Blood flow restriction (BFR) therapy has demonstrated benefits across a spectrum of musculoskeletal injuries, including improved strength, endurance, function, ...

4. ctv.veeva.com ctv.veeva.com/study/comparison-of-methods-in-post-operative-hip-arthroscopy-rehabilitation

Comparison of Methods in Post Operative Hip Arthroscopy ... The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip ...

5. withpower.com withpower.com/trial/phase-hip-injuries-2022-e63f8

BFR Therapy for Hip Surgery Rehabilitation Research shows that Blood Flow Restriction (BFR) therapy can improve muscle strength and function in various conditions, including after surgeries and for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25000220

Blood flow restriction therapy for revolutionizing ... Results show that BFRT is generally safe and has few adverse effects, with tolerance problems leading to session cancellations and limb occlusion pressure ...

7. jospt.org jospt.org/doi/10.2519/jospt.2019.8375

Blood Flow Restriction Resistance Exercise as a ... Blood flow restriction (BFR) resistance exercise has emerged as a promising means of augmenting traditional low-intensity physical rehabilitation exercise.

8. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.808622/full

A Useful Blood Flow Restriction Training Risk Stratification ... A recent systematic review concluded that exercise with BFR does not exacerbate the activation of coagulation or enhance fibrinolytic activity (Nascimento et al ...