Blood Flow Restriction Therapy for Ruptured Achilles Tendon

Overseen By Haley Goble

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Obesity, Diabetes, Cardiovascular, 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: 5

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether blood flow restriction therapy (BFRT) can accelerate recovery after surgery for a torn Achilles tendon. The researchers aim to determine if this therapy can prevent muscle shrinkage, improve recovery outcomes, and reduce the time needed to resume normal activities. Participants will be divided into two groups: one will receive the new therapy with a special tourniquet during exercises, while the other will follow the usual rehabilitation process. The trial seeks adults who have undergone Achilles tendon surgery and can attend physical therapy sessions at a specific location. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery methods for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that blood flow restriction therapy is safe for Achilles tendon rehabilitation?

Research has shown that blood flow restriction therapy (BFRT) is generally safe. One study found that using BFRT for 12 weeks was safe and feasible for patients who didn't undergo surgery, meaning they managed the treatment well without major problems.

Some reports indicate that patients have experienced improvements in function and pain after using BFRT. While no serious issues were reported, individual experiences can differ. Overall, evidence suggests that patients tolerate BFRT well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about blood flow restriction therapy for a ruptured Achilles tendon because it offers a novel approach to rehabilitation. Unlike standard care, which typically involves gradual physical therapy to restore the tendon, this technique uses a tourniquet to restrict blood flow during specific exercises. This method may enhance muscle strength and recovery speed, potentially allowing patients to regain full function more quickly. By simulating high-intensity training at lower loads, it could reduce the risk of further injury while still promoting effective healing.

What evidence suggests that blood flow restriction therapy is effective for Achilles tendon rupture?

Research shows that blood flow restriction therapy (BFRT), which participants in this trial may receive, can aid recovery from an Achilles tendon rupture. Studies have found that BFRT helps maintain calf muscle strength and size after surgery. In some cases, it also improved movement and reduced pain. This therapy uses a special cuff to limit blood flow during exercise, enhancing muscle recovery even with lighter weights. Early evidence suggests that BFRT may help individuals return to their activities more quickly after an Achilles injury. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently undergone surgery to repair a ruptured Achilles tendon. Specific eligibility criteria are not provided, but typically participants would need to be in stable health post-surgery and able to commit to the rehabilitation program.

Inclusion Criteria

I am undergoing or scheduled for PARS or open repair surgery.

Proposed PT with Methodist Location

I am 18 years old or older.

Exclusion Criteria

Pregnant

I have heart, kidney, liver, or lung disease.

Unable to complete a minimum of 85% of the assigned rehabilitation sessions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants complete full body composition scans (DEXA) and questionnaires before surgery

1 week

1 visit (in-person)

Post-operative Treatment

Participants undergo either BFR therapy in addition to standard PT or standard PT alone

16 weeks

Twice a week (in-person)

Follow-up

Participants are monitored for muscle mass preservation, bone density, range of motion, and patient-reported outcomes

16 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Blood flow restriction with Delfi PTS

Trial Overview The study is testing whether using blood flow restriction therapy alongside physical therapy after an Achilles tendon rupture surgery can reduce muscle loss, improve patient outcomes, and shorten the time it takes for athletes to return to their sport.

How Is the Trial Designed?

Group I: Standard of Care (control) group Experimental Treatment 1 Intervention

The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.

Group II: Blood flow restriction group Experimental Treatment 2 Interventions

The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.

Blood flow restriction with Delfi PTS is already approved in United States, European Union for the following indications:

Approved in United States as Blood Flow Restriction Therapy for:

• Post-surgical rehabilitation
• Musculoskeletal injuries
• Sports injuries
• Joint pain
• Tendinopathies
• Fractures
• Osteoporosis

Approved in European Union as Blood Flow Restriction Therapy for:

• Rehabilitation after Achilles tendon rupture
• Muscle strengthening
• Pain relief
• Pre-surgical strengthening
• Post-surgical rehabilitation

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) 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]

In a controlled study involving 40 rats, ischemic therapies like blood flow restriction therapy (BFRT) and repetitive restriction of muscle blood flow (RRMBF) did not lead to improvements in muscle mass, strength, or satellite cell density, suggesting limited efficacy for these methods in enhancing muscle function.

However, the RRMBF group showed significantly elevated growth hormone (GH) levels, indicating a potential biochemical response to this type of ischemic therapy, even though it did not translate to physical improvements in muscle characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. Ramme, AJ., Darcy, R., Rourke, BJ., et al.[2020]

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) can be beneficial for rehabilitation but poses risks such as increased blood pressure and adverse cardiovascular responses, especially in individuals with pre-existing conditions like hypertension and diabetes.

To ensure safety, a risk stratification tool is recommended for clinicians to assess patients' medical histories and identify those who may be at higher risk for complications when undergoing BFRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. Nascimento, DDC., Rolnick, N., Neto, IVS., 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]

Blood flow restriction training (BFRT) was safely applied to two female athletes with shoulder pain, resulting in significant improvements in shoulder function, range of motion, and muscle strength after 16 to 22 treatment sessions.

The study suggests that BFRT could be an effective addition to traditional rehabilitation methods for managing subacromial pain, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. Miller, M., Zeppieri, G., Farmer, KW., et al.[2023]

A review of 21 randomized controlled trials found that Blood Flow Restriction Therapy (BFRT) combined with exercise did not significantly improve athletic performance, muscle strength, or hypertrophy compared to exercise alone.

Both immediate and long-term effects of BFRT on sprint and jump performance, as well as muscle strength and hypertrophy, showed no significant differences, suggesting that BFRT may not provide additional benefits over traditional exercise methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction therapy with exercise are no better than exercise alone in improving athletic performance, muscle strength, and hypertrophy: a systematic review and meta-analysis. Khurana, D., Dutta, N., Malik, S., et al.[2023]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S095825922400066X

The effectiveness of low-load Blood flow restriction ... Blood flow restriction exercise (BFRE) is effective at low weight loads. Evaluation of the effectiveness of BFRE in Achilles tendon rupture rehabilitation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8792708/

Effect of Blood Flow Restriction Therapy Following Achilles ... This is a randomized controlled trial designed to study whether BFR can minimize loss of calf strength and muscle volume after Achilles rupture.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08734-5

The impact of blood flow restriction training on tendon ... Additionally, five case reports using BFRT demonstrated improvements in functional outcomes and pain [35, 48,49,50,51]. However, one study ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06254794

Effect of BFR Rehab After Achilles Tendon Rupture The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, ...

5. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2022.879860/full

Blood Flow Restriction Resistance Training in Tendon ... In the rehabilitation of ACL ruptures, LL-BFRT has been found to be a beneficial training method for increasing muscular adaptations in those who have ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096532/

The impact of blood flow restriction training on tendon ... BFRT conditions showed a significant decrease in tendon thickness at all measurement points, whereas HLRT and LLRT conditions demonstrated ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06434272

Blood Flow Restriction Exercise in Patients With an ... The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture ...