Blood Flow Restriction Training for Ruptured Achilles Tendon

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blood flow restriction resistance training (BFR-RT) aids recovery after Achilles tendon rupture surgery. The main goal is to determine if BFR-RT improves muscle recovery and functional outcomes compared to standard physical therapy or a sham version of BFR-RT. Participants will be divided into groups receiving either BFR-RT, the sham version, or standard physical therapy. This trial suits individuals who have undergone Achilles tendon surgery within the last two weeks and are committed to following a specific rehab plan. As an unphased trial, it offers a unique opportunity to contribute to innovative rehabilitation research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using fluoroquinolone antibiotics or systemic corticosteroids, you cannot participate if you've used them in the past 6 months.

What prior data suggests that blood flow restriction resistance training is safe for postoperative muscle recovery?

Research has shown that blood flow restriction resistance training (BFR-RT) is generally safe and well-tolerated. Several reports, including those on Achilles tendon injuries, indicate significant improvements in muscle strength and power without serious side effects. For instance, one study found a 55.8% increase in plantarflexion strength, which is the ability to point the foot downward, after six weeks of BFR training.

Another report noted that this type of training can safely help prevent muscle loss during recovery. While results can vary, evidence suggests that BFR-RT can be safely used in rehabilitation settings, especially under the supervision of trained professionals.12345

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction Resistance Training (BFR-RT) for Achilles tendon ruptures because it combines traditional physical therapy with an innovative technique that uses the Delfi Personalized Tourniquet System. This system applies calibrated pressure to partially restrict blood flow during low-load resistance exercises, which can enhance muscle strength and recovery without the need for heavy weights. Unlike standard rehabilitation, which focuses solely on range-of-motion and strengthening exercises, BFR-RT may accelerate healing and improve muscle function more efficiently. This potential for faster and more effective recovery is what makes BFR-RT a promising addition to the current treatment landscape for Achilles tendon injuries.

What evidence suggests that blood flow restriction resistance training could be effective for Achilles tendon rupture recovery?

Research has shown that Blood Flow Restriction Resistance Training (BFR-RT), a treatment under study in this trial, aids muscle recovery after an Achilles tendon rupture. Studies have found that BFR-RT can significantly increase strength, with some individuals experiencing up to a 55.8% improvement in ankle strength. It promotes muscle growth similar to traditional heavy weightlifting but without placing heavy stress on the tendon. This method helps maintain calf muscle size and enhances muscle function during tendon healing. Additionally, BFR-RT increases tendon stiffness, aiding recovery.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 who have had a recent (within 2 weeks) Achilles tendon rupture in one leg and received surgical repair. Participants must be willing and able to follow the rehab program and attend scheduled follow-ups.

Inclusion Criteria

I am willing and able to follow the rehab plan and attend all follow-up visits.
I am between 18 and 75 years old.
I have a recent tear in the middle of one Achilles tendon.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo postoperative rehabilitation with or without blood flow restriction resistance training

12 months
Regular supervised sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up evaluations at 6 weeks, 3 months, 4.5 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction Resistance Training (BFR-RT)
  • Sham Blood Flow Restriction

Trial Overview

The study compares three groups: blood flow restriction resistance training (BFR-RT) plus standard physical therapy, sham BFR-RT plus standard therapy, and standard physical therapy alone. The goal is to see if BFR-RT helps muscle recovery after Achilles tendon surgery.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Blood Flow Restriction Resistance Training + Standard Physical TherapyExperimental Treatment2 Interventions
Group II: Standard Physical Therapy AloneActive Control1 Intervention
Group III: Sham Blood Flow Restriction + Standard Physical TherapyPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Blood Flow Restriction Resistance Training in Tendon ... - PMC

For example, BFRT has been found to be an efficacious method for increasing strength gains and muscle hypertrophy in rehabilitation following surgery for ...

The Impact of Blood Flow Restriction Resistance Training ...

Outcomes will be compared between groups to evaluate the efficacy and safety of BFR-RT in postoperative Achilles tendon rupture rehabilitation. Masking ...

Blood Flow Restriction Training After Achilles Tendon ...

He was subsequently enrolled in a 6-week course of BFR training. He experienced plantarflexion strength improvements of 55.8% and 47.1% and power gains of 68.8% ...

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.

THE ACHILLES RECOVERY PROBLEM BFR WAS MADE ...

BFR has been shown to increase Achilles tendon stiffness similarly to high-load resistance training, meaning there is no clinical downside to ...

The impact of blood flow restriction training on tendon ... - PMC

The present scoping review shows contradictory results regarding tendon-related outcomes although studies point to increasing tendon function after ...

Use of Blood Flow Restriction Therapy in Perioperative ...

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in the rehabilitation of Achilles tendon rupture (ATR).

Low-load blood flow restriction (BFR) training induces ...

Low-load blood flow re-striction training induces similar morphological and mechanical Achilles tendon adap-tations compared with high-load resistance training.