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

Trial Summary

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 data supports the effectiveness of the treatment Blood Flow Restriction Therapy for ruptured Achilles tendon?

Research shows that Blood Flow Restriction Therapy (BFRT) can help improve muscle strength and mass, which is beneficial for rehabilitation after injuries. It has been effective in strengthening muscles and preventing muscle loss in various conditions, suggesting it could aid recovery in tendon injuries like a ruptured Achilles tendon. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy generally safe for humans?

Blood Flow Restriction Therapy (BFRT) is generally considered safe for healthy individuals, but it may cause increased blood pressure and other cardiovascular issues, especially in people with existing health conditions like heart disease or diabetes. It's important to have a medical evaluation before starting BFRT to ensure it's safe for you. ^{1 5 6 7 8}

How is Blood Flow Restriction Therapy different from other treatments for a ruptured Achilles tendon?

Blood Flow Restriction Therapy (BFRT) is unique because it allows for strength training with low loads by restricting blood flow to the muscles, which can help improve muscle function and strength without the need for heavy weights. This makes it particularly useful for early rehabilitation stages, potentially leading to faster recovery compared to traditional methods that require higher intensity exercises. ^{1 3 4 5 6}

What is the purpose of this trial?

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.

Eligibility Criteria

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.

I have diabetes.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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) 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) 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]

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) 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]

References

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

Local and Systemic Effects of Blood Flow Restriction Therapy in an Animal Model. [2020]

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

Blood Flow Restriction Training for Subacromial Pain: Two Case Reports. [2023]

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. 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]

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

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

7. England 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. [2022]