Tibial FractureBOOSTNCT07103252
Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Fractures
A study testing Blood Flow Restriction Therapy in people with Tibial Fracture, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Blood Flow Restriction Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
- Must speak English
- Must be able to comply with protected weight bearing instructions for at least 6 weeks
- Must be able to consent for inclusion into the trial
Who cannot join
- Patients who have sustained multiple fractures in the same limb (i.e. AO/OTA 3 and 4, or 4 and 8 etc).
- Patients who have a neurovascular injury associated with the fracture
- Patients who have sustained bilateral lower limb injuries
- Patients aged <19 and >60
- Patients with known peripheral vascular disease or vascular repair
- Patients with known coagulation disorders
Show all 11Show fewer
- Patients with compartment syndrome
- Patients with free tissue transfer for soft tissue coverage
- Patients with ongoing VTE or infection in the affected limb
- Non-ambulatory patients
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z1M9
Kelly Lefaivre, MD MSc FRCSC, 604-875-5809, Kelly.Lefaivre@vch.ca
Kelly Lefaivre, MD MSc FRCSC
About this study
Official title: BOOST- Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Orthopaedic Trauma
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.
Read the 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
- Being tested
- Blood Flow Restriction Therapy
- Keywords
- Blood Flow Restriction Therapy, Lower Extremity, Tibia, Feasibility Study, Leg Injuries, Fractures, Bone, Quadriceps Muscle
- Medical subject headings
- Tibial Fractures, Leg Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Physiotherapy without BFRT |
| Blood Flow Restriction Therapy (BFRT) | Experimental | Physiotherapy with BFRT Receives: Other: Blood Flow Restriction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who consent to participate
Percentage of participants approached for recruitment who consent to study participation
Measured: 12 weeks
Number of participants self-reporting adherence to treatment protocol
Percentage of participants enrolled in the study who report to completing their prescribed post injury physiotherapy sessions
Measured: 12 weeks
Number of participants missing data on regular assessment
Percentage of participants with missing data on regular assessment
Measured: 12 weeks
Number of participants who withdraw from the study
Percentage of participants enrolled in the study who withdraw before completion of the study
Measured: 12 weeks
Number of participants who complete follow up at 12 weeks
Percentage of enrolled participants who complete all follow up visits
Measured: 12 weeks
Muscle strength tension and compression in pounds
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)
Measured: 0, 2, 6, 12 weeks post injury/surgery
Muscle size of the affected limb measured in centimeters
Muscle size of participants estimated by measuring muscle circumference of thigh at 10 cm above superior pole of patella in affected limb
Measured: 0, 2, 6, 12 weeks post injury/surgery
Range of motion in degrees
Range of motion (degrees) of participants' knees (flexion, extension and rotation) and ankles (dorsiflexion and plantar flexion) using a goniometer.
Measured: 0, 2, 6, 12 weeks post injury/surgery
Physical and mental health (SF12)
Physical and mental health of participants assessed using the short form health survey (SF12)
Measured: 0, 2, 6, 12 weeks post injury/surgery
Ambulatory status
Percentage of participants who do or do not require a walking aid including cane, walker, wheelchair, or other.
Measured: 0, 2, 6 and 12 weeks post the injury/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the treatment arm or control arm.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- AO North America
- Responsible party
- Principal investigator, Kelly A. Lefaivre, University of British Columbia
- Investigators
- David Stockton, MD MSc FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103252
- Sponsor's protocol ID
- H25-01080
- Acronym
- BOOST
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Will Individual participant data be available? Yes- only as permitted by UBC's Clinical Research Ethics Board 2. What data: Individual participant data that underlie the results reported in an published article, after deidentification (text, tables, figures) only as permitted by UBC's Clinical Research Ethics Board 3. Other documentation: Study protocol, statistical analysis plan, informed consent 4. When data is available: Beginning 3 months and ending 24 months following publication. 5. With whom: Researchers whose proposed use of the data has been approved by UBC's Clinical Research Ethics Board. 6. Types of analyses: To achieve the aims in the proposal approved by UBC's Clinical Research Ethics Board. 7. Data made available: proposals may be submitted up to 24 months following article publication.
Publications
Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.
PubMed 28213598Franz A, Ji S, Bittersohl B, Zilkens C, Behringer M. Impact of a Six-Week Prehabilitation With Blood-Flow Restriction Training on Pre- and Postoperative Skeletal Muscle Mass and Strength in Patients Receiving Primary Total Knee Arthroplasty. Front Physiol. 2022 Jun 14;13:881484. doi: 10.3389/fphys.2022.881484. eCollection 2022.
PubMed 35774280Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.
PubMed 31301034Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.
PubMed 31725362Fan Y, Bai D, Cheng C, Tian G. The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. Ann Med. 2023;55(2):2240329. doi: 10.1080/07853890.2023.2240329.
PubMed 37505919Lixandrao ME, Ugrinowitsch C, Laurentino G, Libardi CA, Aihara AY, Cardoso FN, Tricoli V, Roschel H. Effects of exercise intensity and occlusion pressure after 12 weeks of resistance training with blood-flow restriction. Eur J Appl Physiol. 2015 Dec;115(12):2471-80. doi: 10.1007/s00421-015-3253-2. Epub 2015 Sep 1.
PubMed 26323350Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
PubMed 19952261Spranger MD, Krishnan AC, Levy PD, O'Leary DS, Smith SA. Blood flow restriction training and the exercise pressor reflex: a call for concern. Am J Physiol Heart Circ Physiol. 2015 Nov;309(9):H1440-52. doi: 10.1152/ajpheart.00208.2015. Epub 2015 Sep 4.
PubMed 26342064Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Larose G, Roffey DM, Broekhuyse HM, Guy P, O'Brien P, Lefaivre KA. Trajectory of Recovery following ORIF for Distal Radius Fractures. J Wrist Surg. 2023 Jul 13;13(3):230-235. doi: 10.1055/s-0043-1771045. eCollection 2024 Jun.
PubMed 38808181Middleton SD, Guy P, Roffey DM, Broekhuyse HM, O'Brien PJ, Lefaivre KA. Long-Term Trajectory of Recovery Following Pilon Fracture Fixation. J Orthop Trauma. 2022 Jun 1;36(6):e250-e254. doi: 10.1097/BOT.0000000000002312.
PubMed 34799544GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
PubMed 34723233
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOST- Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Orthopaedic Trauma
- ClinicalTrials.gov ID
- NCT07103252
- Acronym / sponsor ID
- BOOST / H25-01080
- Conditions
- Tibial Fracture
- Keywords
- Blood Flow Restriction Therapy, Lower Extremity, Tibia, Feasibility Study, Leg Injuries, Fractures, Bone, Quadriceps Muscle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- AO North America
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the treatment arm or control arm.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Physiotherapy without BFRT |
| Blood Flow Restriction Therapy (BFRT) | Experimental | Other: Blood Flow Restriction TherapyPhysiotherapy with BFRT |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
- Must speak English
- Must be able to comply with protected weight bearing instructions for at least 6 weeks
- Must be able to consent for inclusion into the trial
Key exclusion criteria (11 listed)
- Patients who have sustained multiple fractures in the same limb (i.e. AO/OTA 3 and 4, or 4 and 8 etc).
- Patients who have a neurovascular injury associated with the fracture
- Patients who have sustained bilateral lower limb injuries
- Patients aged <19 and >60
- Patients with known peripheral vascular disease or vascular repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TherapyPersonalized 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. | Other | Blood Flow Restriction Therapy (BFRT) |
Primary outcome
Number of participants who consent to participate
Time frame: 12 weeks
Percentage of participants approached for recruitment who consent to study participation
Number of participants self-reporting adherence to treatment protocol
Time frame: 12 weeks
Percentage of participants enrolled in the study who report to completing their prescribed post injury physiotherapy sessions
Number of participants missing data on regular assessment
Time frame: 12 weeks
Percentage of participants with missing data on regular assessment
Number of participants who withdraw from the study
Time frame: 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
Time frame: 12 weeks
Percentage of enrolled participants who complete all follow up visits
Muscle strength tension and compression in pounds
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 0, 2, 6, 12 weeks post injury/surgery
Physical and mental health of participants assessed using the short form health survey (SF12)
Ambulatory status
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 28213598Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.
- Background: PubMed 35774280Franz A, Ji S, Bittersohl B, Zilkens C, Behringer M. Impact of a Six-Week Prehabilitation With Blood-Flow Restriction Training on Pre- and Postoperative Skeletal Muscle Mass and Strength in Patients Receiving Primary Total Knee Arthroplasty. Front Physiol. 2022 Jun 14;13:881484. doi: 10.3389/fphys.2022.881484. eCollection 2022.
- Background: PubMed 31301034Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.
- Background: PubMed 31725362Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.
- Background: PubMed 37505919Fan Y, Bai D, Cheng C, Tian G. The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. Ann Med. 2023;55(2):2240329. doi: 10.1080/07853890.2023.2240329.
- Background: PubMed 26323350Lixandrao ME, Ugrinowitsch C, Laurentino G, Libardi CA, Aihara AY, Cardoso FN, Tricoli V, Roschel H. Effects of exercise intensity and occlusion pressure after 12 weeks of resistance training with blood-flow restriction. Eur J Appl Physiol. 2015 Dec;115(12):2471-80. doi: 10.1007/s00421-015-3253-2. Epub 2015 Sep 1.
- Background: PubMed 19952261Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
- Background: PubMed 26342064Spranger MD, Krishnan AC, Levy PD, O'Leary DS, Smith SA. Blood flow restriction training and the exercise pressor reflex: a call for concern. Am J Physiol Heart Circ Physiol. 2015 Nov;309(9):H1440-52. doi: 10.1152/ajpheart.00208.2015. Epub 2015 Sep 4.
- Background: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Background: PubMed 38808181Larose G, Roffey DM, Broekhuyse HM, Guy P, O'Brien P, Lefaivre KA. Trajectory of Recovery following ORIF for Distal Radius Fractures. J Wrist Surg. 2023 Jul 13;13(3):230-235. doi: 10.1055/s-0043-1771045. eCollection 2024 Jun.
- Background: PubMed 34799544Middleton SD, Guy P, Roffey DM, Broekhuyse HM, O'Brien PJ, Lefaivre KA. Long-Term Trajectory of Recovery Following Pilon Fracture Fixation. J Orthop Trauma. 2022 Jun 1;36(6):e250-e254. doi: 10.1097/BOT.0000000000002312.
- Background: PubMed 34723233GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
- Individual participant dataSharing planned: Yes. 1. Will Individual participant data be available? Yes- only as permitted by UBC's Clinical Research Ethics Board 2. What data: Individual participant data that underlie the results reported in an published article, after deidentification (text, tables, figures) only as permitted by UBC's Clinical Research Ethics Board 3. Other documentation: Study protocol, statistical analysis plan, informed consent 4. When data is available: Beginning 3 months and ending 24 months following publication. 5. With whom: Researchers whose proposed use of the data has been approved by UBC's Clinical Research Ethics Board. 6. Types of analyses: To achieve the aims in the proposal approved by UBC's Clinical Research Ethics Board. 7. Data made available: proposals may be submitted up to 24 months following article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Stockton, MD MSc FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Therapy in people with Tibial Fracture, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Lefaivre, MD MSc FRCSC (604-875-5809, Kelly.Lefaivre@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who consent to participate (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07103252, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.