40 Participants Needed

Blood Flow Restriction Training for ACL Reconstruction Recovery

AP
AF
Overseen ByArthur Fredericks, MSPT
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Connecticut Children's Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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 idea that Blood Flow Restriction Training for ACL Reconstruction Recovery is an effective treatment?

The available research does not provide any data on Blood Flow Restriction Training for ACL Reconstruction Recovery. Instead, it focuses on the use of tumor necrosis factor inhibitors for rheumatoid arthritis, which is unrelated to ACL recovery.12345

Is Blood Flow Restriction Training safe for humans?

Blood Flow Restriction (BFR) training, which uses a tourniquet to limit blood flow during exercise, is generally considered safe when used correctly. Advances in personalized tourniquet systems have reduced the risk of injuries, such as nerve damage, by controlling pressure levels, making BFR a safer option for improving muscle strength and recovery.678910

How does blood flow restriction training differ from other treatments for ACL reconstruction recovery?

Blood flow restriction training is unique because it uses a cuff to partially block blood flow during exercise, allowing patients to train with lighter weights while still gaining strength and muscle size, unlike traditional high-load training.79111213

What is the purpose of this trial?

While there are a number studies that have reported on the use of blood flow restriction training (BFRT) in the adult population, there is limited information about the use of BFRT in the adolescent population. This study aims to evaluate the use of BFRT in conjunction with traditional anterior ligament reconstruction (ACLR) rehabilitation in adolescents.The purpose of this study is to compare the addition of a BFRT based exercise protocol to a standard ACL rehabilitation protocol in adolescents. Does the addition of BFRT-based exercise improve strength, hypertrophy, and patient reported outcomes after ACLR in the adolescent population?

Research Team

AW

Adam Weaver, PT, DPT

Principal Investigator

Physical Therapist

Eligibility Criteria

This trial is for adolescents who have had ACL reconstruction and were active in sports before their injury. They must have completed surgery and physical therapy at Connecticut Children's, following standard protocols, without other major knee injuries or surgeries, weight bearing restrictions over 4 weeks due to additional pathology, or follow-up procedures like arthrofibrosis.

Inclusion Criteria

Before surgery, you participated in more than 50 hours per year of intense sports and plan to go back to that level after the surgery.
I completed orthopedic surgery and physical therapy at Connecticut Children's.
I have finished my post-surgery rehab according to the standard plan.

Exclusion Criteria

I cannot attend most of my physical therapy sessions.
I must limit putting weight on my leg for over 4 weeks after surgery due to other knee issues.
I have another leg injury or had surgery on either knee.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction surgery followed by a rehabilitation protocol, with the experimental group receiving additional blood flow restriction training (BFRT) exercises.

8 weeks
2 visits per week (in-person)

Follow-up

Participants are monitored for changes in strength, hypertrophy, and patient-reported outcomes at various intervals post-operation.

2 years
Regular follow-up visits at 3, 6, 9 months, and 2 years post-op

Treatment Details

Interventions

  • Delfi Personalized Tourniquet System
Trial Overview The study tests if adding Blood Flow Restriction Training (BFRT) using the Delfi Personalized Tourniquet System to standard ACL rehab improves strength, muscle growth, and patient outcomes in adolescents after ACL reconstruction compared to just the standard rehab protocol.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BFR Intervention GroupExperimental Treatment1 Intervention
In addition to the standard ACL rehabilitation protocol, the experimental group will complete 2 exercises using the Delfi BFR cuff 2x/week for 8 weeks during their treatment session at Connecticut Children's Sports Physical Therapy on the second post-operative visit. Cuff size will be determined by patient thigh circumference Limb occlusion pressure will be determined in supine position and all exercises will be completed at 80% occlusion. Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press
Group II: No Intervention/Control GroupActive Control1 Intervention
In addition to the standard ACL rehabilitation protocol, the control group will complete the same exercises as the experimental group starting on the second post-operative visit. Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press

Find a Clinic Near You

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials
76
Recruited
30,000+

University of Connecticut

Collaborator

Trials
194
Recruited
162,000+

Findings from Research

A consensus among 15 Italian rheumatologists found that starting TNF inhibitors (TNFi) immediately in DMARDs-naïve patients with early rheumatoid arthritis (RA) does not significantly improve clinical, functional, or radiographic outcomes compared to a step-up approach within 12 weeks.
The review included 6 studies with a total of 1080 records, indicating that while TNFi can be effective, the optimal timing for its use in treatment strategies for early RA remains uncertain and requires further investigation.
Immediate treatment with tumour necrosis factor inhibitors in synthetic disease-modifying anti-rheumatic drugs-naïve patients with rheumatoid arthritis: results of a modified Italian Expert Consensus.Bortoluzzi, A., Valesini, G., D'Angelo, S., et al.[2018]
In a study of 1,818 elderly patients with rheumatoid arthritis undergoing major surgeries, the timing of infliximab infusion before surgery did not affect the risk of post-operative infections or mortality.
Post-operative infection rates varied among different surgical procedures, but there was no increased risk associated with receiving infliximab closer to the time of surgery, suggesting that withholding TNF inhibitors may not be necessary.
Pre-operative withholding of infliximab and the risk of infections after major surgery in patients with rheumatoid arthritis.Ward, MM., Dasgupta, A.[2021]
Tumor necrosis factor inhibitors (TNFi) are effective biologic therapies for rheumatoid arthritis (RA) with a proven clinical efficacy, but they are associated with a range of potential adverse events, from mild to serious.
Despite the risks, the overall safety profile of TNFi is reasonable, and with proper screening and ongoing monitoring, the benefits of treatment generally outweigh the risks, especially when compared to the dangers of untreated RA.
The safety of tumor necrosis factor-alpha inhibitors in the treatment of rheumatoid arthritis.Hernández, MV., Sanmartí, R., Cañete, JD.[2017]

References

Immediate treatment with tumour necrosis factor inhibitors in synthetic disease-modifying anti-rheumatic drugs-naïve patients with rheumatoid arthritis: results of a modified Italian Expert Consensus. [2018]
Pre-operative withholding of infliximab and the risk of infections after major surgery in patients with rheumatoid arthritis. [2021]
The safety of tumor necrosis factor-alpha inhibitors in the treatment of rheumatoid arthritis. [2017]
Comparing a tapering strategy to the standard dosing regimen of TNF inhibitors in rheumatoid arthritis patients with low disease activity. [2017]
Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis-a proof of principle and exploratory trial: is dose tapering practical in good responders? [2022]
Tourniquet-induced nerve compression injuries are caused by high pressure levels and gradients - a review of the evidence to guide safe surgical, pre-hospital and blood flow restriction usage. [2020]
Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial. [2023]
Acute Blood Flow Responses to Varying Blood Flow Restriction Pressures in the Lower Limb. [2023]
Blood Flow Restriction Training for Athletes: A Systematic Review. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
A SYSTEMATIC REVIEW OF THE EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE ATROPHY AND CIRCUMFERENCE POST ACL RECONSTRUCTION. [2022]
Blood flow restriction training in South Africa - a panel discussion. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. [2020]
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