Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT07103252

Tibial Fracture

NOT_YET_RECRUITING NA

Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery

NCT06589115

Tibial Plateau Fractures

WITHDRAWN NA

Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures

NCT01457326

Lower Extremity Periarticular Fractures

TERMINATED

The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

NCT04809714

Hip Fractures Muscle Atrophy

ACTIVE_NOT_RECRUITING NA

Improving Functional Recovery After Hip Fracture

NCT00000436

Unilateral Hip Fracture

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tibial Fractures Lower Extremity Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be assigned to experimental group performing exercise with blood flow restriction, or to the control group performing exercises without the device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood flow restriction training

Patients will perform exercises as directed by a Doctor of Physical Therapy with the use of blood flow restriction device

Group Type EXPERIMENTAL

Blood Flow Restriction with low load exercise

Intervention Type DEVICE

Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.

Traditional physical therapy

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.

Group Type ACTIVE_COMPARATOR

Therapeutic Exercise

Intervention Type OTHER

Exercise performed at appropriate load as guided by physical therapist

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Flow Restriction with low load exercise

Cuff/tourniquet will be applied to proximal leg at hip crease and inflated to 60-80% of limb occlusion pressure to decrease venous blood flow in the limb while performing exercise.

Intervention Type DEVICE

Therapeutic Exercise

Exercise performed at appropriate load as guided by physical therapist

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes