Blood Flow Restriction Therapy for Tibial Fractures

(BOOST Trial)

Overseen By Kelly Lefaivre, MD MSc FRCSC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Multiple fractures, Neurovascular injury, Bilateral injuries, Peripheral vascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blood flow restriction therapy can aid recovery in individuals with tibia (lower leg bone) fractures. The therapy aims to enhance muscle size and strength by enabling earlier physiotherapy post-surgery. Participants will receive either standard physiotherapy or physiotherapy combined with this new therapy. Individuals with a single tibia fracture, who are following non-weight bearing instructions for at least six weeks, and can communicate in English may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery for future patients.

Do I need to stop my current medications for the trial?

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 tibial fractures?

Research has shown that blood flow restriction therapy (BFRT) is generally safe. Studies have found that this therapy can increase muscle size and strength without stressing healing tissues, which is especially beneficial for those recovering from injuries like broken shin bones.

In some studies, BFRT combined with sports activities reduced pain and aided muscle recovery. Another study found it did not cause major side effects, indicating most participants did not experience serious problems.

However, clear guidelines for using BFRT safely and effectively are lacking. While many have used it without issues, following healthcare professionals' advice is crucial. Overall, BFRT appears to be a promising and safe option for muscle recovery, especially when regular exercise isn't feasible. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Blood Flow Restriction Therapy (BFRT) is unique because it offers a new approach to rehabilitation for tibial fractures by limiting blood flow during physiotherapy. Unlike traditional physiotherapy, which focuses on standard exercises, BFRT uses cuffs to restrict blood flow to the muscles. This technique potentially enhances muscle strength and recovery with less stress and strain on the healing bone. Researchers are excited about this therapy because it could speed up recovery times and improve outcomes for patients with tibial fractures, offering a promising alternative to conventional methods.

What evidence suggests that blood flow restriction therapy is effective for tibia fractures?

This trial will compare Blood Flow Restriction Therapy (BFRT) with standard physiotherapy for tibial fractures. Studies have shown that BFRT can significantly aid recovery from shinbone fractures. Research indicates that BFRT helps muscles regain strength and size more quickly after surgery by enabling earlier physical therapy. One study found that individuals using BFRT alongside regular therapy experienced better muscle recovery than those who did not. Another study reported positive outcomes, suggesting that BFRT complements standard treatments effectively. Overall, evidence supports that BFRT can enhance recovery after a lower leg fracture. ^{1 2 6 7 8}

Who Is on the Research Team?

David Stockton, MD MSc FRCSC

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 19-60 who have a single lower limb tibia fracture requiring at least 6 weeks of limited weight on the leg. They must be able to follow instructions and consent to participate. Excluded are those with multiple fractures, soft tissue injuries needing surgery, nerve or blood vessel damage, under 19 or over 60 years old, pregnant women, bilateral limb injuries, vascular diseases or repairs, ongoing vein thrombosis or infections in the limb.

Inclusion Criteria

Must be able to consent for inclusion into the trial

Must speak English

I am between 19 and 60 years old with a broken tibia needing 6 weeks of limited weight on it.

Exclusion Criteria

Patients with compartment syndrome

Patients who have sustained multiple fractures in the same limb

I have had surgery to move healthy skin to a part of my body that needed it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive physiotherapy with or without Blood Flow Restriction Therapy from week 2 to week 12 post injury or surgery

10 weeks

Biweekly visits (in-person)

Follow-up

Participants are monitored for muscle strength, size, and range of motion at 0, 2, 6, and 12 weeks post injury/surgery

12 weeks

4 visits (in-person)

Extension

Potential continuation of monitoring for long-term outcomes and feasibility of a future definitive trial

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Therapy

Trial Overview The study tests blood flow restriction therapy's ability to improve muscle size and strength during recovery from lower leg bone fractures. Participants will receive personalized therapy that may enable earlier physiotherapy and better rehabilitation outcomes after their surgical treatment.

How Is the Trial Designed?

Group I: Blood Flow Restriction Therapy (BFRT) Experimental Treatment 1 Intervention

Physiotherapy with BFRT

Group II: Control Active Control 1 Intervention

Physiotherapy without BFRT

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

AO North America

Collaborator

Trials

3

Recruited

140+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07103252

Blood Flow Restriction Therapy to Optimize Muscle Size ... This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368450/

The Impact of Blood Flow Restriction Training on Tibial ... On average, participants completed 6.80 ± 1.15 treatments. The average time under occlusion for an individual treatment session was 21.34 ± 2.71 ...

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08424-2

The effectiveness of individualized blood flow restriction ... The results showed that the individualized blood flow restriction training was feasible and suggested promising outcomes for participants after surgery.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666337623000811

Blood flow restriction training improves the efficacy of ... Four-weeks BFRT improves the effect of the routine intervention, and BFRT-related interventions are recommended for CAI patients with severe ankle muscle mass ...

5. ctv.veeva.com ctv.veeva.com/study/blood-flow-restriction-therapy-improves-tibial-plateau-fracture-recovery

Blood Flow Restriction Therapy Improves Tibial Plateau ... The goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction (BFR) therapy.

6. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/126963-low-load-blood-flow-restriction-training-for-medial-tibial-stress-syndrome-in-athletes-a-case-series

Low-Load Blood-flow Restriction Training for Medial Tibial ... This case series presents a therapeutic exercise program utilizing LL-BFR training, implemented in conjunction with sports activities, that reduced pain and ...

7. scholars.indianastate.edu scholars.indianastate.edu/cgi/viewcontent.cgi?article=1106&context=clinat

Safety of Blood Flow Restriction Training for Musculoskeletal ... Currently, there are no definitive set of parameters for clinicians to follow to ensure safe and effective use of BFRT. The purpose of the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8448465/

Blood Flow Restriction Training - PMC Blood flow restriction (BFR) training offers the ability to mitigate weakness and atrophy without overloading healing tissues. It appears to be a safe and ...