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

NCT07103252 | Not Yet Recruiting

• 1 other identifier: H25-01080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fracture

Keywords

Blood Flow Restriction Therapy; Lower Extremity; Tibia; Feasibility Study; Leg Injuries; Fractures, Bone; Quadriceps Muscle

Outcome Measures

Primary Outcomes (10)

• Number of participants who consent to participate

  Percentage of participants approached for recruitment who consent to study participation

  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

  12 weeks

• Number of participants missing data on regular assessment

  Percentage of participants with missing data on regular assessment

  12 weeks

• Number of participants who withdraw from the study

  Percentage of participants enrolled in the study who withdraw before completion of the study

  12 weeks

• Number of participants who complete follow up at 12 weeks

  Percentage of enrolled participants who complete all follow up visits

  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)

  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

  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.

  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)

  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.

  0, 2, 6 and 12 weeks post the injury/surgery

Other Outcomes (2)

• Limb Occlusion Pressure (LOP) in millimeters of mercury (mmHg)

  0, 2, 6, 12 weeks post injury/surgery

• Number of participants with incomplete Limb Occlusion Pressure (LOP)

  0, 2, 6, 12 weeks post injury/surgery

Study Arms (2)

Control

NO INTERVENTION

Physiotherapy without BFRT

Blood Flow Restriction Therapy (BFRT)

EXPERIMENTAL

Physiotherapy with BFRT

Other: Blood Flow Restriction Therapy

Interventions

Blood Flow Restriction Therapy 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.

Blood Flow Restriction Therapy (BFRT)

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of British Columbia: lead
• AO North America: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

Location

Related Publications (12)

• 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.

  PMID: 28213598 BACKGROUND

• Franz 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.

  PMID: 35774280 BACKGROUND

• Hughes 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.

  PMID: 31301034 BACKGROUND

• Centner 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.

  PMID: 31725362 BACKGROUND

• Fan 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.

  PMID: 37505919 BACKGROUND

• Lixandrao 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.

  PMID: 26323350 BACKGROUND

• Noordin 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.

  PMID: 19952261 BACKGROUND

• Spranger 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.

  PMID: 26342064 BACKGROUND

• Garber 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.

  PMID: 21694556 BACKGROUND

• Larose 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.

  PMID: 38808181 BACKGROUND

• Middleton 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.

  PMID: 34799544 BACKGROUND

• GBD 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.

  PMID: 34723233 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures; Leg Injuries; Fractures, Bone

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• David Stockton, MD MSc FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Lefaivre, MD MSc FRCSC

CONTACT

604-875-5809; Kelly.Lefaivre@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCSC

Model Details: Participants are randomly assigned to either the treatment arm or control arm.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 24 months following publication.
• Access Criteria: Individual participant data that underlie the results reported in a published article, after deidentification (text, tables, figures) only as permitted by UBC's Clinical Research Ethics Board. Researchers whose proposed use of the data has been approved by UBC's Clinical Research Ethics Board.

Locations

CA (1)