Blood Flow Restriction Training for Ligament and Joint Health

Overseen By Haley Goble, MHA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Injury, Vascular issues, DVT, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to identify any differences in elbow ulnar collateral ligament (UCL) relative thickness and joint space laxity in the dominant arm following an 8-week course of low intensity resistance exercises with blood flow restriction (BFR) exercises in healthy volunteers. The main questions it aims to answer are: 1. Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space? 2. Are there changes in arm strength following the 8-week strengthening protocol with/without BFR? Participants will: * Complete two BFR sessions a week for a total of eight weeks. * Complete an exercise session with both arms (dominant arm will receive BFR) at each study visit. * Have sonographs taken of the UCL at the first and last study visit. * Complete strength assessments at the first and last study visit.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Blood Flow Restriction Training safe for humans?

Blood Flow Restriction Training (BFRT) has been shown to be relatively safe over the past 25 years, with some reported minor side effects like bruising, lightheadedness, and cramping. It has been used in various settings, including athletic training and rehabilitation, with screening processes often in place to ensure safety. ^{1 2 3 4 5}

How is Blood Flow Restriction Training different from other treatments for ligament and joint health?

Blood Flow Restriction Training (BFRT) is unique because it uses a cuff to partially restrict blood flow, which can enhance muscle strength and recovery with lower intensity exercises compared to traditional methods. This makes it particularly useful for rehabilitation and improving musculoskeletal health without the need for heavy weights. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Blood Flow Restriction Training for ligament and joint health?

Research shows that Blood Flow Restriction Training (BFRT) can help improve muscle strength and physical function in people with knee osteoarthritis and chronic ankle instability. It is also beneficial in reducing muscle loss and improving knee strength after ligament surgery. ^{1 4 5 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in an 8-week study to assess the effects of low intensity resistance exercises with blood flow restriction on their dominant arm's elbow ligament and joint space. Participants must be able to commit to two sessions per week.

Inclusion Criteria

Healthy volunteer

Agree to complete all exercise sessions and program in its entirety

Exclusion Criteria

Current participation in other BFR research study

I have had a deep vein thrombosis (DVT) before.

I cannot exercise due to a condition affecting my muscles or bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete two BFR sessions a week for a total of eight weeks, with sonographs and strength assessments at the first and last study visit

8 weeks

16 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 Training

Trial Overview The trial tests if using a Delfi PTS Blood Flow Restriction Tourniquet System during exercise affects the thickness of the ulnar collateral ligament or causes changes in joint space and arm strength over eight weeks, compared to exercising without BFR.

How Is the Trial Designed?

Group I: BFR Training on the UCL Experimental Treatment 1 Intervention

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

Approved in United States as Blood Flow Restriction Training for:

• Rehabilitation after patellar instability
• Post-operative rehabilitation
• Muscle strengthening in patients with injuries or physical limitations

Approved in European Union as Blood Flow Restriction Training for:

• Rehabilitation after orthopedic surgeries
• Muscle strengthening in elderly and arthritic patients
• Post-operative rehabilitation

Approved in Japan as KAATSU Training for:

• Muscle strengthening and hypertrophy
• Rehabilitation after injuries
• Improving muscle endurance

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

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) shows promising preliminary evidence for improving tendon health and clinical outcomes, based on a review of 13 studies involving various tendon conditions.

However, due to the limited number of studies and the variability in intervention parameters, more research is needed to establish definitive conclusions and recommendations for BFRT in tendon rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. Burton, I., McCormack, A.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 32 adolescents (16 in the BFRT group and 16 in the control group), blood flow restriction training (BFRT) significantly improved isometric knee extension strength at both 3 months post-surgery and at the time of return to sport compared to traditional rehabilitation alone.

The BFRT group also reported better functional outcomes, as indicated by higher Pediatric International Knee Documentation Committee (Pedi-IKDC) scores, demonstrating enhanced patient-reported function after ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. Roman, DP., Burland, JP., Fredericks, A., et al.[2023]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

Blood flow restriction (BFR) training is considered a safe and effective method for improving musculoskeletal training outcomes, supported by 25 years of research.

There is a need for standardized, evidence-based protocols for BFR training among health professionals in South Africa to ensure its proper and safe application during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. Evans, RW., Ganda, J., van Schalkwyk, L., et al.[2023]

A survey of 108 participants using BFR/KAATSU devices revealed that 61.4% used inflatable devices, and most had received some form of education before using the equipment, indicating a commitment to safe application of the training method.

Adverse effects such as bruising, lightheadedness, and cramping were reported by 21.4% of users, highlighting the need for careful monitoring and screening before administering BFR/KAATSU training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Trends in Blood Flow Restriction. Cuffe, M., Novak, J., Saithna, A., et al.[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]

Citations

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. [2022]

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

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. [2023]

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

Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction. [2023]

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

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]

6. South Africa pubmed.ncbi.nlm.nih.gov

Blood flow restriction training in South Africa - a panel discussion. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Current Trends in Blood Flow Restriction. [2022]

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

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