Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Not Applicable

Not yet recruiting

• Conditions: Lower Extremity Fracture; Tibial Fractures
• Interventions: Device: Blood Flow Restriction with low load exercise; Other: Therapeutic Exercise

• Registration Number: NCT06496035
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

Detailed Description

This study will examine the effect of blood flow restriction (BFR) training in patients with lower extremity fractures. Patients with tibial shaft fractures will be assigned to either the BFR group or control group. The BFR group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a Doctor of Physical Therapy. The control group will perform the exercises without the device, as is current standard practice in physical therapy. Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. The goal of this study is to examine the use of BFR in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Study Start: 2024-10-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult with closed tibial shaft fracture
• Ability to begin physical therapy treatment within 2 weeks post-operatively

Exclusion Criteria

• History of osteoporosis or osteopenia
• Impaired circulation in the limb
• Active deep vein thrombosis
• Clotting disorders or other elevated risk of embolism
• Sickle cell anemia
• Infection in extremity
• Renal compromise
• Severe uncontrolled hypertension (SBP>180)
• Lymphedema
• Under age 18
• Pregnancy
• Prisoner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood flow restriction training	Blood Flow Restriction with low load exercise	Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device
Traditional physical therapy	Therapeutic Exercise	Patients perform physical therapy exercises guided by a Doctor of Physical Therapy without the use of a blood flow restriction device, as is current standard practice.

Primary Outcome Measures

Name	Time	Method
Fracture healing	6 weeks, 12 weeks, 6 months	Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures

Secondary Outcome Measures

Name	Time	Method
Muscle strength	2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months	Knee extension and ankle plantarflexion strength measured with a dynamometer
Muscle girth	2, 4, 6, 12 weeks and 6 months	Quadriceps and gastrocnemius muscle girth measured 15 cm above and below joint line
Physical function	2, 6,12 weeks and 6 months	Subjective measure of function measured by Lower Extremity Functional Scale (LEFS)

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States