Blood Flow Restriction Training in Patients With Lower Extremity Fractures

NCT06496035 | Recruiting FDA Device

• 1 other identifier: 24-0894
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fractures; Lower Extremity Fracture

Outcome Measures

Primary Outcomes (1)

• Fracture healing

  Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures

  6 weeks, 12 weeks, 6 months

Secondary Outcomes (3)

• Muscle strength

  2 weeks, 4 weeks, 6 weeks, 12 weeks, and 6 months

• Muscle girth

  2, 4, 6, 12 weeks and 6 months

• Physical function

  2, 6,12 weeks and 6 months

Study Arms (2)

Blood flow restriction training

EXPERIMENTAL

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

Device: Blood Flow Restriction with low load exercise

Traditional physical therapy

ACTIVE COMPARATOR

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.

Other: Therapeutic Exercise

Interventions

Blood Flow Restriction with low load exercise 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.

Blood flow restriction training

Therapeutic Exercise OTHER

Exercise performed at appropriate load as guided by physical therapist

Traditional physical therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Megan E Smith, PT, DPT

  Denver Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan E Smith, PT, DPT

CONTACT

6513191730; megan.smith@dhha.org

Mathew A Haager, PT, DPT

CONTACT

5639407061; mat.haager@dhha.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible due to evident use or nonuse of device, and documentation in patient's chart.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)