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

Trial Summary

What is the purpose of this trial?

The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.

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 data supports the effectiveness of the treatment 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 musculoskeletal injuries. It has been effective in enhancing rehabilitation by increasing muscle mass and reducing pain, which suggests it could be beneficial for hip surgery recovery as well. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy generally safe for humans?

Blood Flow Restriction Therapy (BFR) has been shown to be a safe method for rehabilitation, allowing patients to start strength training earlier and improve recovery. It has been used safely in both civilian and military populations, with documented benefits and adaptations in muscle strength and function. ^{1 2 5 6 7}

How does BFR therapy differ from other treatments for hip surgery rehabilitation?

BFR therapy is unique because it allows patients to perform low-weight exercises while restricting blood flow, which mimics the effects of high-load exercises without putting stress on the joints. This makes it particularly beneficial for those who cannot tolerate traditional high-load exercises, promoting muscle strength and growth with less risk of injury. ^{1 3 4 8 9}

Research Team

James Genuario, MD

Principal Investigator

University of Colorado SOM

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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) 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) 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]

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 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]

References

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

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. [2022]

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

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

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

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

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]

5. India pubmed.ncbi.nlm.nih.gov

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

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

Blood Flow Restriction Therapy: From Development to Applications. [2020]

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

Blood Flow Restriction Training Can Improve Peak Torque Strength in Chronic Atrophic Postoperative Quadriceps and Hamstrings Muscles. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. [2020]

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

Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. [2020]