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

Not Applicable

Not yet recruiting

• Conditions: Tibial Fracture

• Registration Number: NCT07103252
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-09-01
• Primary Completion: 2027-04
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who consent to participate	12 weeks	Percentage of participants approached for recruitment who consent to study participation
Number of participants missing data on regular assessment	12 weeks	Percentage of participants with missing data on regular assessment
Number of participants self-reporting adherence to treatment protocol	12 weeks	Percentage of participants enrolled in the study who report to completing their prescribed post injury physiotherapy sessions
Number of participants who withdraw from the study	12 weeks	Percentage of participants enrolled in the study who withdraw before completion of the study
Number of participants who complete follow up at 12 weeks	12 weeks	Percentage of enrolled participants who complete all follow up visits
Muscle strength tension and compression in pounds	0, 2, 6, 12 weeks post injury/surgery	Muscle strength of participants measured as force, tension and compression in pounds, in the affected limb using a dynamometer force gauge (ergoFET Digital Force Gauge)
Muscle size of the affected limb measured in centimeters	0, 2, 6, 12 weeks post injury/surgery	Muscle size of participants estimated by measuring muscle circumference of thigh at 10 cm above superior pole of patella in affected limb
Range of motion in degrees	0, 2, 6, 12 weeks post injury/surgery	Range of motion (degrees) of participants' knees (flexion, extension and rotation) and ankles (dorsiflexion and plantar flexion) using a goniometer.
Physical and mental health (SF12)	0, 2, 6, 12 weeks post injury/surgery	Physical and mental health of participants assessed using the short form health survey (SF12)
Ambulatory status	0, 2, 6 and 12 weeks post the injury/surgery	Percentage of participants who do or do not require a walking aid including cane, walker, wheelchair, or other.

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada