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?

This trial tests whether a special exercise method called blood flow restriction (BFR) can change the thickness of a specific elbow ligament and improve joint flexibility. It targets individuals without injuries who are willing to engage in eight weeks of low-intensity exercises. Healthy individuals who can commit to this program may be suitable candidates. The trial also examines whether these exercises can increase arm strength. Participants will exercise twice a week and undergo scans and strength tests at the beginning and end of the trial. As an unphased trial, this study offers a unique opportunity to explore innovative exercise methods and contribute to advancing fitness science.

Will I have to stop taking my current medications?

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

What prior data suggests that blood flow restriction training is safe for ligament and joint health?

Research has shown that blood flow restriction (BFR) training is generally well-tolerated and can improve muscle strength while reducing pain. Studies have found that using light weights with BFR strengthens muscles and lessens pain. For instance, BFR training can increase quadriceps (thigh muscles) strength by about 15-30% and lower pain levels.

Although these studies have not reported major side effects, participants should pay attention to their body's response during training. BFR has been safely used in various situations, such as aiding recovery after knee surgeries. This suggests that BFR could be a safe option for those in this trial aiming to improve elbow ligament and joint health. Participants should always discuss any concerns with the research team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction (BFR) Training for ligament and joint health because it offers a novel approach by enhancing muscle strength and recovery without the need for heavy weightlifting. Unlike standard rehabilitation methods, which often involve extensive physical therapy and sometimes surgery for conditions like ligament injuries, BFR Training uses a unique mechanism. It involves applying a specialized cuff to restrict blood flow partially, stimulating muscle growth and repair with lighter loads. This technique not only reduces stress on joints and ligaments but also shortens recovery time, making it a promising alternative to traditional treatments.

What evidence suggests that Blood Flow Restriction Training is effective for ligament and joint health?

Studies have shown that blood flow restriction training (BFRT) can improve muscle strength, size, and performance. Some research suggests that BFRT might aid knee function in the medium term, but it does not significantly boost early muscle strength recovery. In the short term, BFRT can reduce knee pain, but it does not improve knee function or strength more than traditional methods. This trial will specifically investigate the effects of BFRT on the elbow's ulnar collateral ligament (UCL). Although limited data exists on BFRT's impact on the UCL, its ability to enhance muscles suggests potential benefits for ligaments and joints. Overall, BFRT appears promising for boosting physical performance and muscle health. ^{2 5 6 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

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]

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 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]

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]

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) 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]

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39350350/

The Efficacy of Blood Flow Restriction Training to Improve ... Conclusions: The addition of BFRT to a rehabilitation program for athletes pre- and post-ACLR was no more effective than standard rehabilitation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1466853X25000744

Blood flow restriction training compared to conventional ... Blood flow restriction training can significantly reduce short-term knee pain. No significant effects on knee function or strength were identified.

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05673-8

The effects of blood flow restriction training on early muscle ... BFRT demonstrated limited effectiveness in early muscle strength recovery during ACLR rehabilitation but may have a positive impact on mid-term knee function.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06664827/blood-flow-restriction-bfr-training-on-the-ulnar-collateral-ligament-ucl

Blood Flow Restriction (BFR) Training on the Ulnar ... The goal of this clinical trial is to identify any differences in elbow ulnar collateral ligament (UCL) relative thickness and joint space ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06406907

Effects of Short Duration Blood Flow Restriction Training on ... Short duration BFRT studies have positive effects on muscle strength, muscle size, performance, hormonal levels, inflammatory marks and satellite cells. However ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11346237/

Acute and Chronic Effects of Blood Flow Restriction ... This systematic review has highlighted BFR for ACL reconstruction rehabilitation. Low loads combined with BFR improve pain, muscle strength, function, and CSA.

7. medrxiv.org medrxiv.org/content/10.1101/2025.10.12.25337802v1.full-text

Blood Flow Restriction Training After ACL Reconstruction Across the eight RCTs, BFR training improved quadriceps strength (≈ 15–30 %), increased or preserved CSA (+10–12 %), reduced pain (–1 to –3 VAS ...

8. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12527

Comparison of blood flow restriction training rehabilitation and ... Blood flow restriction training (BFRT) has been found to reduce quadriceps atrophy and weakness after anterior cruciate ligament (ACL) surgery.