Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Fractures

NCT ID: NCT07103252

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-31

Brief Summary

This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone). Personalized blood flow restriction therapy has shown to help people regain muscle size and strength after surgical treatment by allowing them to be able to start physiotherapy on their injured leg sooner. This study aims to evaluate the feasibility and effectiveness of personalized blood flow restriction therapy to improve thigh muscle size and strength in patients with lower limb tibia fractures which require a period of non-weightbearing.

Detailed Description

Lower limb fractures constitute the largest burden of fracture care globally. It is well documented that major upper and lower extremity trauma results in significant disability, with a protracted trajectory of recovery. A large proportion of these fracture can require a period of immobilization or protected weight bearing for up to 12 weeks depending on the nature, location and treatment of the fracture. Loss of muscle bulk and functional strength can occur with immobilization and disuse in as early as five days, and is confounded by severity of injury. Rehabilitation of these patients is focused on regaining range of motion, muscle strength and return to function. Traditional regimens to increase muscle size require exercises to be performed at high loads and intensities, typically at 60%-70% of a person's one repetition maximum. Due to the prolonged period of weight bearing protection and/or immobilization, and the recovery from the traumatic injury itself, most patients are unable to engage in high intensity and load exercises. This limits their ability to improve muscle size and strength and in turn slows down their return to function.

Blood flow restriction therapy (BFRT) originated in the 1960s in Japan. However, this initial approach was wrought with poor safety and reliability. The implementation of the automatic pneumatic tourniquet in 1979 allowed for the pressure applied by the tourniquet to be reliably controlled and replicated. Since then, multiple studies have been done to improve upon the technique, with the main aims to identify the optimal occlusion pressure and extent of blood flow restriction.

Blood flow restriction works on the principle of restricting arterial inflow and occluding venous outflow from the chosen limb. The personalized aspect is drawn from the fact that the pressure applied is a pre-determined percentage of the patient's Limb Occlusion Pressure (LOP). LOP is defined as the minimum pressure required, at a specific time by a specific tourniquet cuff applied to a specific patient's limb at a specific location, to stop the flow of arterial blood into the limb distal to the cuff. Benefits have been shown with blood flow restriction at 40%-80% of the patient's LOP. Further, despite the relationship between blood flow and fracture healing, studies in upper limb fractures have demonstrated that the reduced blood flow does not have a detrimental effect on bony union.

Personalized blood flow restriction therapy (BFRT) can help achieve similar muscle growth by performing exercises at lower loads and intensities (20%-30%) of one repetition maximum. There is significant excitement around this concept in elective orthopaedics, and this treatment modality has been shown to be effective in rehabilitation from ACL reconstruction, total knee replacements, wrist fractures and Achilles tendon ruptures. Although what is known about recovery and long-term disability in lower extremity orthopaedic trauma patients makes them an obvious candidate for this, there is a lack of evidence for use in lower limb fractures. With this pilot study, the investigators hope to demonstrate the feasibility of conducting a larger RCT on this topic.

Hypotheses The investigators hypothesize that personalized BFRT will be tolerated by patients from 2 weeks post injury with increasing tolerance overtime. Personalized BFRT will demonstrate an increase in quadriceps muscle size and strength in the injured leg at 12 weeks following injury. The treatment effects of BFRT on lower extremity strength at 12 weeks in fracture patients will be used to inform the sample size calculation of a future definitive trial. The investigators further hypothesize that the proposed pilot trial will demonstrate feasibility of a future definitive trial.

Research design and methods This is a pilot study at a Level 1 Trauma Center (Vancouver General Hospital) involving patients with a peri-articular tibial fracture (treated operatively or non-operatively) which require a minimum 6 weeks of protected weight bearing (non weight bearing or partial weight bearing). Patients will be randomised to one of two groups - Physiotherapy with or without Blood Flow Restriction Therapy (PT with BFRT or PT without BFRT). Potential patients will be identified in the Orthopaedic Trauma outpatient clinic and physiotherapy departments. Recruitment and screening will be carried out as approved by the UBC Clinical Research Ethics Board. All patients presenting with a peri-articular tibial fracture (treated operatively or non-operatively) will be pre-screened, assigned a screening number, and recorded in a de-identified site screening log by the Orthopaedic Trauma research team. Those deemed potentially eligible will be approached by the research personnel. Informed, voluntary consent will be obtained from patients in a non-coercive manner. Patients will be enrolled for biweekly physiotherapy treatments from week 2 to week 12 post injury or post surgery. They will remain non-weightbearing for 6 weeks following the injury or surgery (first 4 weeks of physiotherapy). They Both groups will have standard clinical follow up at 2 weeks, 6 weeks and 12 weeks post injury/surgery.

Once local ethics approval and the pneumatic tourniquet have been received and the pneumatic tourniquet, the training planned for two of our hospital physiotherapists will be finalized. These therapists work full time in the outpatient setting, which is dedicated to the care of injured patients, and where baseline therapy is completely funded by the local Health Authority. Local expertise for training, and preliminary collaborations have been established. Patients will be assigned to one of two of these physiotherapists regardless of whether they are allocated to the PT with BFRT or PT without BFRT.

Conditions

Tibial Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Physiotherapy without BFRT

Group Type: NO_INTERVENTION

No interventions assigned to this group

Blood Flow Restriction Therapy (BFRT)

Physiotherapy with BFRT

Group Type: EXPERIMENTAL

Blood Flow Restriction Therapy

Intervention Type: OTHER

Personalized Blood Flow Restriction Therapy uses an an inflatable cuff (Delfi PTS system) around the upper thigh which partially restricts arterial inflow during exercise. BFR allows for similar improvements of muscular strength and muscle mass as traditional heavy load strength training while using significantly lower loads. The reduced stress on supporting tissues ( tendons, joints, bones and ligaments) allows people who normally couldn't tolerate high loads to enhance their strength and muscle mass.

Interventions

Blood Flow Restriction Therapy

Personalized Blood Flow Restriction Therapy uses an an inflatable cuff (Delfi PTS system) around the upper thigh which partially restricts arterial inflow during exercise. BFR allows for similar improvements of muscular strength and muscle mass as traditional heavy load strength training while using significantly lower loads. The reduced stress on supporting tissues ( tendons, joints, bones and ligaments) allows people who normally couldn't tolerate high loads to enhance their strength and muscle mass.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients aged 19-60 who have sustained an isolated (single bone/area as per AO/OTA classification) unilateral lower limb fracture of the tibia that requires a period of 6 weeks of protected weight bearing (non-weight bearing or toe touch weight bearing)

2. Must speak English

3. Must be able to comply with protected weight bearing instructions for at least 6 weeks

4. Must be able to consent for inclusion into the trial

Exclusion Criteria

1. Patients who have sustained multiple fractures in the same limb (i.e. AO/OTA 3 and 4, or 4 and 8 etc).

2. Patients who have a neurovascular injury associated with the fracture

3. Patients who have sustained bilateral lower limb injuries

4. Patients aged <19 and >60

5. Patients with known peripheral vascular disease or vascular repair

6. Patients with known coagulation disorders

7. Patients with compartment syndrome

8. Patients with free tissue transfer for soft tissue coverage

9. Patients with ongoing VTE or infection in the affected limb

10. Non-ambulatory patients

11. Patients who are pregnant

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO North America

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kelly A. Lefaivre

MD, MSc, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Stockton, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Kelly Lefaivre, MD MSc FRCSC

Role: CONTACT

Kelly.Lefaivre@vch.ca

604-875-5809

Facility Contacts

Kelly Lefaivre, MD MSc FRCSC

Role: primary

Kelly.Lefaivre@vch.ca

604-875-5809

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Other Identifiers

H25-01080

Identifier Type: -

Identifier Source: org_study_id